Adenocarcinoma of the Prostate, Stage II Prostate Cancer
Conditions
Brief summary
This randomized phase II trial studies how well finasteride works in treating patients with stage II prostate cancer who are undergoing surgery. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using finasteride may fight prostate cancer by lowering the amount of testosterone the body makes. Giving finasteride before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Detailed description
PRIMARY OBJECTIVES: I. Compare the frequency of discriminating molecular marker expression in Gleason grade (GG) 3 cores, adjusted for Gleason score (GS) at prostatectomy, in patients with stage II prostate cancer treated with neoadjuvant finasteride vs placebo. SECONDARY OBJECTIVES: I. Compare the frequency with which grade 3 and grade 4 tumors occur in these patients. II. Determine the frequency of discriminating molecular signature expression in tissue microarray cores segregated by GS at prostatectomy in these patients. III. Compare GG 3-appearing areas (in tumors rated GS 6 at prostatectomy) in patients treated with finasteride vs placebo. IV. Compare GG 3-appearing areas (in tumors rated GS 7 at prostatectomy) in patients treated with finasteride vs placebo. V. Compare GG 4-appearing areas (in tumors rated GS 7 at prostatectomy) in patients treated with finasteride vs placebo. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to study site, Gleason score (6 vs 7), and type of prostatectomy (open vs robotic/laparoscopic). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive finasteride orally (PO) once daily (QD) for 4-6 weeks, and then undergo prostatectomy. Arm II: Patients receive placebo PO QD for 4-6 weeks, and then undergo prostatectomy. Tumor tissue obtained at prostatectomy is used to make tissue microarrays and is analyzed by immunohistochemistry for molecular marker expression studies. After completion of study treatment, patients are followed up for 30 days.
Interventions
PROCEDUREProstatectomy
Undergo prostatectomy
OTHERLaboratory biomarker analysis
Correlative studies
DRUGFinasteride
Given PO
OTHERPlacebo
Given PO
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Criteria: * Histologically confirmed adenocarcinoma of the prostate * Clinical stage T1c or T2 (stage II) * Gleason score of 6 or 7 on initial biopsy * Prostate-specific antigen (PSA) level less than 10 ng/mL within the past 3 months * Candidate for and scheduled to undergo prostatectomy * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS 70-100% * Fertile patients must use effective contraception * No active malignancy at any other site * No history of allergic reactions attributed to compounds of similar chemical or biological composition to finasteride * No uncontrolled intercurrent illness including, but not limited to, any of the following: Ongoing or active infection; Symptomatic congestive heart failure; Unstable angina pectoris; Cardiac arrhythmia * No psychiatric illness or social situation that would preclude study compliance * More than 6 months since prior hormonal agents, including dutasteride or finasteride * More than 6 months since prior chemotherapy * More than 1 month since prior participation in another investigational study * No prior radiotherapy for the primary tumor * No concurrent dehydroepiandrosterone, phytoestrogen supplements, antiandrogen therapy, dutasteride, or other finasteride * No concurrent anticoagulation, except for the use of daily acetylsalicylic acid (81 mg to 325 mg)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | At prostatectomy following maximum 6 week treatment period | Molecular marker expression based on tissue microarray (TMA) derived from dominant tumor focus. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: vascular epithelial growth factor (VEFG), estrogen receptor beta (ERβ), androgen receptor (AR), 3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), ubiquitin-conjugating enzyme E2C (UBE2C), and Cleaved Caspase 3 (Caspase). P values are based on non-parametric Wilcoxon rank-sum test. |
| Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | At prostatectomy following maximum 6 week treatment period | Biomarkers using pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. P values are based on non-parametric Wilcoxon rank-sum test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Secondary) | Assessment following maximum 6 week treatment period and prostatectomy | Frequency of Grade 3, Grade 4 and Grade 5 tumors in two treatment groups: Participants will consist of men with adenocarcinoma of the prostate, clinical stage T1c or T2, with a Gleason score of 6 or 7 and a PSA level \< 10 ng/mL, who are scheduled to undergo prostatectomy. |
| Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor, Node, Metastasis (TNM) Stage | Assessment following maximum 6 week treatment period and prostatectomy | American Joint Committee on Cancer (AJCC) system 6th edition (2002) describing amount and spread of cancer body, using TNM. T describes the size of the tumor and any spread of cancer into nearby tissue; N describes spread of cancer to nearby lymph nodes; and M describes metastasis (spread of cancer to other parts of the body). Numbers after the T (such as T1, T2, T3, and T4) describe tumor size and/or amount of spread into nearby structures. The higher the T number, the larger the tumor and/or the more it has grown into nearby tissues where T3a reflects tumor has spread through the capsule on one or both sides; and T3b reflects tumor has invaded one or both seminal vesicles. |
| Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Margin of Resection (MOR) | Assessment following maximum 6 week treatment period and prostatectomy | Edge or border of tissue removed in cancer surgery. The margin is described as negative or clean when the pathologist finds no cancer cells at the edge of the tissue, suggesting that all of the cancer has been removed. The margin is described as positive or involved when the pathologist finds cancer cells at the edge of the tissue, suggesting that all of the cancer has not been removed. |
| Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Lymph Node Status | Assessment following maximum 6 week treatment period and prostatectomy | Status of cancer spread to lymph nodes; PN0 Cancer that has not spread to the lymph nodes. Cancer that has not spread to the lymph nodes. The N category describes whether the cancer has spread into nearby lymph nodes. NX means the nearby lymph nodes cannot be evaluated. N0 means nearby lymph nodes do not contain cancer. Numbers after the N (such as N1, N2, and N3) describe the size, location, and/or the number of nearby lymph nodes affected by cancer. The higher the N number, the greater the cancer spread to nearby lymph nodes. |
| Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci | Assessment following maximum 6 week treatment period and prostatectomy | Diagnosis of a small focus of prostatic adenocarcinoma on a prostate needle biopsy from pathologist's identification of an architecturally abnormal focus of epithelial structures at rather low magnification. |
| Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS) | Assessment following maximum 6 week treatment period and prostatectomy | Tumor distribution within zones of the prostate using radical prostatectomy specimen (RPS) where number of foci categorized by zone defined as: PZ, peripheral zone; TZ, transition zone; CZ, central zone. |
| Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin -- Dominant Tumor Focus | Assessment following maximum 6 week treatment period and prostatectomy | Dominant tumor focus, distribution within zones of the prostate using radical prostatectomy specimen (RPS) where number of foci categorized by zone defined as: PZ, peripheral zone; TZ, transition zone; CZ, central zone. Dominant tumor focus is the largest, index lesion, single high risk focus of the prostate cancer. |
| Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Upgrade Between Biopsy and Prostatectomy | Baseline biopsy to prostatectomy following maximum 6 week treatment period | Change in Gleason Score from biopsy to prostatectomy where an upgrade refers to a higher Gleason Score signifying worsening of tumor. Gleason scoring (GS) to based on microscopic appearance using 2005 International Society of Urological Pathologists recommendation. |
| Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor Volume (Cubic Centimeter) | Baseline biopsy to prostatectomy following maximum 6 week treatment period | Characteristics of tumor considering total zone cancer volume, and cancer volume using zonal foci categorized as: PZ, peripheral zone; TZ, transition zone; CZ, central zone. |
| Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score | Assessment following maximum 6 week treatment period and prostatectomy | Frequency of Grade 3 and Grade 4 tumors in two treatment groups: Participants consist of men with adenocarcinoma of prostate, clinical stage T1c or T2, with Gleason score of 6 or 7 and PSA level \< 10 ng/mL, who are scheduled to undergo prostatectomy. 2005 International Society of Urological Pathologists recommendations for Gleason scoring (GS) used to grade tumors based upon its microscopic appearance: a primary grade is assigned to most common tumor pattern, and a second grade to next most common tumor pattern. Gleason score (GS) is sum of the two Gleason grades, based on scale of 2-10 with lowest numbers indicating slow-growing tumor unlikely to spread and highest numbers indicating an aggressive tumor. Gleason grade = 1-5; Gleason score = 2-10; 5 and 10 indicate worst prognosis. American Joint Committee on Cancer (AJCC) staging describes extent of disease progression utilizing TNM scoring system: Tumor size, Lymph Nodes affected, Metastases. Higher stage cancers are more advanced. |
| Characteristics of Blood Biomarkers: Testosterone (ng/dL) Percentage Change | Baseline biopsy to prostatectomy following maximum 6 week treatment period | Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood tests used for measuring the amount of testosterone in the blood. |
| Characteristics of Blood Biomarkers: Dihydrotestosterone (ng/dL) Percentage Change | Baseline biopsy to prostatectomy following maximum 6 week treatment period | Characteristics of blood biomarkers using pretreatment and posttreatment values. Dihydrotestosterone (DHT) blood test measures serum concentrations of dihydrotestosterone and is closely related to those of testosterone. |
| Characteristics of Blood Biomarkers: Estrone (ng/dL) Percentage Change | Baseline biopsy to prostatectomy following maximum 6 week treatment period | Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood test used to measure Estrone (E1), one of the three estrogens, which also includes estriol and estradiol. |
| Characteristics of Blood Biomarkers: Estradiol (ng/dL) Percentage Change | Baseline biopsy to prostatectomy following maximum 6 week treatment period | Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood test used to measure Estradiol. |
| Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean) | At prostatectomy following maximum 6 week treatment period | Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. |
| Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean) | At prostatectomy following maximum 6 week treatment period. | Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. |
| Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups | At prostatectomy following maximum 6 week treatment period | Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. P values are based on non-parametric Wilcoxon rank-sum test. |
| Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups | At prostatectomy following maximum 6 week treatment period. | Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. P values are based on non-parametric Wilcoxon rank-sum test. |
| Characteristics of Blood Biomarkers: Prostate-specific Antigen (ng/mL) Percentage Change (%) | Baseline biopsy to prostatectomy following maximum 6 week treatment period | Characteristics of blood biomarkers using pretreatment and posttreatment values. Prostate-specific antigen (PSA) blood test measuring protein produced by prostate cells. |
| Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Primary) | Assessment following maximum 6 week treatment period and prostatectomy | Frequency of Grade 3 and Grade 4 tumors in two treatment groups: Participants consist of men with adenocarcinoma of the prostate, clinical stage T1c or T2, with a Gleason score of 6 or 7 and a PSA level \< 10 ng/mL, who are scheduled to undergo prostatectomy. |
Countries
United States
Participant flow
Recruitment details
Recruitment period: From 2007 to 2012 recruitment was done at various medical clinic locations.
Pre-assignment details
Of the 210 participants recruited, 204 were randomized to the study.
Participants by arm
| Arm | Count |
|---|---|
| Arm I (Finasteride) Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy. | 89 |
| Arm II (Placebo) Placebo once daily for 4-6 weeks, then undergo prostatectomy. | 94 |
| Total | 183 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Incomplete data submission | 0 | 2 |
| Overall Study | Terminated Early | 14 | 5 |
Baseline characteristics
| Characteristic | Arm II (Placebo) | Total | Arm I (Finasteride) |
|---|---|---|---|
| Age, Continuous | 62 years | 60 years | 59 years |
| Race/Ethnicity, Customized Asian | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Black | 7 participants | 12 participants | 5 participants |
| Race/Ethnicity, Customized Hispanic | 2 participants | 7 participants | 5 participants |
| Race/Ethnicity, Customized White | 85 participants | 163 participants | 78 participants |
| Region of Enrollment United States | 94 participants | 183 participants | 89 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 94 Participants | 183 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 89 | 0 / 94 |
| serious Total, serious adverse events | 0 / 89 | 0 / 94 |
Outcome results
Primary
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy
Molecular marker expression compared between tumor foci using Biomarkers pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.
Time frame: At prostatectomy following maximum 6 week treatment period.
Population: Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | UBE2C (N=34,55) | 0.5 Percentage of tumor cell involvement | Standard Deviation 0.4 |
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | ERβ (N=35, 55) | 18.1 Percentage of tumor cell involvement | Standard Deviation 15.6 |
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | AR (N=35, 54) | 69.8 Percentage of tumor cell involvement | Standard Deviation 17.3 |
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | Ki-67 (N=37,54) | 1.6 Percentage of tumor cell involvement | Standard Deviation 1.4 |
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | SRD5A2 (N=45,47) | 72.9 Percentage of tumor cell involvement | Standard Deviation 37 |
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | Caspase (N=38,55) | 0.4 Percentage of tumor cell involvement | Standard Deviation 0.7 |
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | VEGF (N=37,55) | 63.9 Percentage of tumor cell involvement | Standard Deviation 36.3 |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | AR (N=35, 54) | 72.4 Percentage of tumor cell involvement | Standard Deviation 16.7 |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | VEGF (N=37,55) | 63.7 Percentage of tumor cell involvement | Standard Deviation 38 |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | UBE2C (N=34,55) | 0.5 Percentage of tumor cell involvement | Standard Deviation 0.5 |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | ERβ (N=35, 55) | 14.8 Percentage of tumor cell involvement | Standard Deviation 14.7 |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | SRD5A2 (N=45,47) | 64.7 Percentage of tumor cell involvement | Standard Deviation 43.7 |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | Caspase (N=38,55) | 0.2 Percentage of tumor cell involvement | Standard Deviation 0.2 |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | Ki-67 (N=37,54) | 1.5 Percentage of tumor cell involvement | Standard Deviation 1 |
Primary
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy
Molecular marker expression based on tissue microarray (TMA) derived from dominant tumor focus. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: vascular epithelial growth factor (VEFG), estrogen receptor beta (ERβ), androgen receptor (AR), 3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), ubiquitin-conjugating enzyme E2C (UBE2C), and Cleaved Caspase 3 (Caspase). P values are based on non-parametric Wilcoxon rank-sum test.
Time frame: At prostatectomy following maximum 6 week treatment period
Population: Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | VEGF (N=37,55) | 80 Percentage tumor cell involvement |
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | AR (N=35, 54) | 75.2 Percentage tumor cell involvement |
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | Ki-67 (N=37,54) | 1.1 Percentage tumor cell involvement |
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | ERβ (N=35, 55) | 15.0 Percentage tumor cell involvement |
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | SRD5A2 (N=45,47) | 100 Percentage tumor cell involvement |
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | UBE2C (N=34,55) | 0.4 Percentage tumor cell involvement |
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | Caspase (N=38,55) | 0.2 Percentage tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | UBE2C (N=34,55) | 0.3 Percentage tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | Caspase (N=38,55) | 0.08 Percentage tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | SRD5A2 (N=45,47) | 90 Percentage tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | VEGF (N=37,55) | 90 Percentage tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | ERβ (N=35, 55) | 6.6 Percentage tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | AR (N=35, 54) | 78.3 Percentage tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy | Ki-67 (N=37,54) | 1.3 Percentage tumor cell involvement |
Comparison: VEGF3, Within GG3p-value: 0.7Wilcoxon (Mann-Whitney)
Comparison: Estrogen receptor beta (ERβ), Within GG3p-value: 0.38Wilcoxon (Mann-Whitney)
Comparison: Androgen receptor (AR), Within GG3p-value: 0.41Wilcoxon (Mann-Whitney)
Comparison: Ki-67 protein, Within GG3p-value: 0.75Wilcoxon (Mann-Whitney)
Comparison: 3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), Within GG3p-value: 0.57Wilcoxon (Mann-Whitney)
Comparison: Ubiquitin-conjugating enzyme E2C (UBE2C), Within GG3p-value: 0.12Wilcoxon (Mann-Whitney)
Comparison: Cleaved Caspase 3 (Caspase), Within GG3p-value: 0.03Wilcoxon (Mann-Whitney)
Primary
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy
Biomarkers using pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. P values are based on non-parametric Wilcoxon rank-sum test.
Time frame: At prostatectomy following maximum 6 week treatment period
Population: Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | Ki-67 (N=48,62) | 1.3 Percentage of tumor cell involvement |
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | AR (N=48,62) | 63.71 Percentage of tumor cell involvement |
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | SRD5A2 (N=38,69) | 95 Percentage of tumor cell involvement |
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | Caspase (N=47,61) | 0.06 Percentage of tumor cell involvement |
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | UBE2C (N=46,62) | 0.3 Percentage of tumor cell involvement |
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | ERβ (N=48,62) | 8.0 Percentage of tumor cell involvement |
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | VEGF (N=48,61) | 85 Percentage of tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | Caspase (N=47,61) | 0.04 Percentage of tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | AR (N=48,62) | 75.9 Percentage of tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | VEGF (N=48,61) | 70 Percentage of tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | ERβ (N=48,62) | 9.5 Percentage of tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | Ki-67 (N=48,62) | 1.4 Percentage of tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | SRD5A2 (N=38,69) | 90 Percentage of tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | UBE2C (N=46,62) | 0.3 Percentage of tumor cell involvement |
Comparison: Vascular Epithelial Growth Factor (VEGF3), Within GG4p-value: 0.45Wilcoxon (Mann-Whitney)
Comparison: Estrogen receptor beta (ERβ), Within GG4p-value: 0.83Wilcoxon (Mann-Whitney)
Comparison: Androgen receptor (AR), Within GG4p-value: 0.04Wilcoxon (Mann-Whitney)
Comparison: Ki-67 protein, Within GG4p-value: 0.8Wilcoxon (Mann-Whitney)
Comparison: 3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), Within GG4p-value: 0.61Wilcoxon (Mann-Whitney)
Comparison: UBE2C, Within GG4p-value: 0.86Wilcoxon (Mann-Whitney)
Comparison: Caspase, Within GG4p-value: 0.02Wilcoxon (Mann-Whitney)
Primary
Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy
Molecular marker expression compared between tumor foci using biomarkers pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.
Time frame: At prostatectomy following maximum 6 week treatment period.
Population: Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | VEGF (N=48,61) | 63.6 Percentage of tumor cell involvement | Standard Deviation 35.5 |
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | ERβ (N=48,62) | 15.0 Percentage of tumor cell involvement | Standard Deviation 15.1 |
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | AR (N=48,62) | 64.3 Percentage of tumor cell involvement | Standard Deviation 16.67 |
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | Ki-67 (N=48,62) | 1.8 Percentage of tumor cell involvement | Standard Deviation 1.6 |
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | SRD5A2 (N=38,69) | 71.8 Percentage of tumor cell involvement | Standard Deviation 37.6 |
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | UBE2C (N=46,62) | 0.5 Percentage of tumor cell involvement | Standard Deviation 0.4 |
| Arm I (Finasteride) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | Caspase (N=47,61) | 0.1 Percentage of tumor cell involvement | Standard Deviation 0.1 |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | Caspase (N=47,61) | 0.06 Percentage of tumor cell involvement | Standard Deviation 0.08 |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | VEGF (N=48,61) | 59.8 Percentage of tumor cell involvement | Standard Deviation 35.4 |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | Ki-67 (N=48,62) | 1.7 Percentage of tumor cell involvement | Standard Deviation 1.4 |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | ERβ (N=48,62) | 16.7 Percentage of tumor cell involvement | Standard Deviation 18.8 |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | UBE2C (N=46,62) | 0.5 Percentage of tumor cell involvement | Standard Deviation 0.4 |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | AR (N=48,62) | 68.6 Percentage of tumor cell involvement | Standard Deviation 23.1 |
| Arm II (Placebo) | Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy | SRD5A2 (N=38,69) | 64.9 Percentage of tumor cell involvement | Standard Deviation 40.8 |
Secondary
Characteristics of Blood Biomarkers: Dihydrotestosterone (ng/dL) Percentage Change
Characteristics of blood biomarkers using pretreatment and posttreatment values. Dihydrotestosterone (DHT) blood test measures serum concentrations of dihydrotestosterone and is closely related to those of testosterone.
Time frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period
Population: Analysis includes all evaluable participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I (Finasteride) | Characteristics of Blood Biomarkers: Dihydrotestosterone (ng/dL) Percentage Change | -64.8 percentage of change |
| Arm II (Placebo) | Characteristics of Blood Biomarkers: Dihydrotestosterone (ng/dL) Percentage Change | -3.6 percentage of change |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Characteristics of Blood Biomarkers: Estradiol (ng/dL) Percentage Change
Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood test used to measure Estradiol.
Time frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period
Population: Analysis includes all evaluable participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I (Finasteride) | Characteristics of Blood Biomarkers: Estradiol (ng/dL) Percentage Change | 7.2 percentage of change |
| Arm II (Placebo) | Characteristics of Blood Biomarkers: Estradiol (ng/dL) Percentage Change | 0 percentage of change |
p-value: 0.254Wilcoxon (Mann-Whitney)
Secondary
Characteristics of Blood Biomarkers: Estrone (ng/dL) Percentage Change
Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood test used to measure Estrone (E1), one of the three estrogens, which also includes estriol and estradiol.
Time frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period
Population: Analysis includes all evaluable participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I (Finasteride) | Characteristics of Blood Biomarkers: Estrone (ng/dL) Percentage Change | -8.9 percentage of change |
| Arm II (Placebo) | Characteristics of Blood Biomarkers: Estrone (ng/dL) Percentage Change | 0 percentage of change |
p-value: 0.805Wilcoxon (Mann-Whitney)
Secondary
Characteristics of Blood Biomarkers: Prostate-specific Antigen (ng/mL) Percentage Change (%)
Characteristics of blood biomarkers using pretreatment and posttreatment values. Prostate-specific antigen (PSA) blood test measuring protein produced by prostate cells.
Time frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period
Population: Analysis includes all evaluable participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I (Finasteride) | Characteristics of Blood Biomarkers: Prostate-specific Antigen (ng/mL) Percentage Change (%) | -39.4 percentage of change |
| Arm II (Placebo) | Characteristics of Blood Biomarkers: Prostate-specific Antigen (ng/mL) Percentage Change (%) | -4.6 percentage of change |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Characteristics of Blood Biomarkers: Testosterone (ng/dL) Percentage Change
Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood tests used for measuring the amount of testosterone in the blood.
Time frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period
Population: Analysis includes all evaluable participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I (Finasteride) | Characteristics of Blood Biomarkers: Testosterone (ng/dL) Percentage Change | 13 percentage of change |
| Arm II (Placebo) | Characteristics of Blood Biomarkers: Testosterone (ng/dL) Percentage Change | -4.6 percentage of change |
p-value: 0.003Wilcoxon (Mann-Whitney)
Secondary
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups
Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. P values are based on non-parametric Wilcoxon rank-sum test.
Time frame: At prostatectomy following maximum 6 week treatment period
Population: Of total 89 enrolled participants in the Finasteride Arm, 62 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups | ERβ (N=35,48) | 15.0 Percentage of tumor cell involvement |
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups | AR (N=35,48) | 75.2 Percentage of tumor cell involvement |
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups | Ki-67 (N=37,48) | 1.1 Percentage of tumor cell involvement |
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups | SRD5A2 (N=45,38) | 100 Percentage of tumor cell involvement |
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups | UBE2C (N=34,46) | 0.4 Percentage of tumor cell involvement |
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups | Caspase (N=38,47) | 0.2 Percentage of tumor cell involvement |
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups | VEGF (N=37,48) | 80 Percentage of tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups | ERβ (N=35,48) | 8.0 Percentage of tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups | UBE2C (N=34,46) | 0.3 Percentage of tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups | AR (N=35,48) | 63.7 Percentage of tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups | VEGF (N=37,48) | 85 Percentage of tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups | Ki-67 (N=37,48) | 1.3 Percentage of tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups | Caspase (N=38,47) | 0.06 Percentage of tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups | SRD5A2 (N=45,38) | 95 Percentage of tumor cell involvement |
Comparison: VEGF3, Within Finasteride Armp-value: 0.84Wilcoxon (Mann-Whitney)
Comparison: ERβ, Within Finasteride Armp-value: 0.36Wilcoxon (Mann-Whitney)
Comparison: AR, Within Finasteridep-value: 0.09Wilcoxon (Mann-Whitney)
Comparison: Ki-67 protein, Within Finasteride Armp-value: 0.46Wilcoxon (Mann-Whitney)
Comparison: SRD5A2, Within Finasteride Armp-value: 0.88Wilcoxon (Mann-Whitney)
Comparison: UBE2C, Within Finasteride Armp-value: 0.18Wilcoxon (Mann-Whitney)
Comparison: Caspase, Within Finasteride Armp-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean)
Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.
Time frame: At prostatectomy following maximum 6 week treatment period
Population: Of total 89 enrolled participants in the Finasteride Arm, 62 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean) | AR (N=35,48) | 69.8 Percentage of tumor cell involvement | Standard Deviation 17.3 |
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean) | SRD5A2 (N=45,38) | 72.9 Percentage of tumor cell involvement | Standard Deviation 37 |
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean) | ERβ (N=35,48) | 18.1 Percentage of tumor cell involvement | Standard Deviation 15.6 |
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean) | UBE2C (N=34,46) | 0.5 Percentage of tumor cell involvement | Standard Deviation 0.4 |
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean) | Ki-67 (N=37,48) | 1.6 Percentage of tumor cell involvement | Standard Deviation 1.4 |
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean) | Caspase (N=38,47) | 0.4 Percentage of tumor cell involvement | Standard Deviation 0.7 |
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean) | VEGF (N=37,48) | 63.9 Percentage of tumor cell involvement | Standard Deviation 36.3 |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean) | Caspase (N=38,47) | 0.1 Percentage of tumor cell involvement | Standard Deviation 0.1 |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean) | VEGF (N=37,48) | 63.7 Percentage of tumor cell involvement | Standard Deviation 35.5 |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean) | ERβ (N=35,48) | 15.0 Percentage of tumor cell involvement | Standard Deviation 15.1 |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean) | AR (N=35,48) | 64.3 Percentage of tumor cell involvement | Standard Deviation 16.7 |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean) | Ki-67 (N=37,48) | 1.8 Percentage of tumor cell involvement | Standard Deviation 1.6 |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean) | SRD5A2 (N=45,38) | 71.8 Percentage of tumor cell involvement | Standard Deviation 37.6 |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean) | UBE2C (N=34,46) | 0.5 Percentage of tumor cell involvement | Standard Deviation 0.4 |
Secondary
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean)
Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.
Time frame: At prostatectomy following maximum 6 week treatment period.
Population: Of total 94 enrolled participants in the Placebo Arm, 68 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean) | AR (N=54,62) | 72.4 Percentage of tumor cell involvement | Standard Deviation 16.7 |
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean) | SRD5A2 (N=47,69) | 64.7 Percentage of tumor cell involvement | Standard Deviation 43.7 |
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean) | ERβ (N=55,62) | 14.8 Percentage of tumor cell involvement | Standard Deviation 14.7 |
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean) | UBE2C (N=55,62) | 0.5 Percentage of tumor cell involvement | Standard Deviation 0.5 |
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean) | Ki-67 (N=54,62) | 1.5 Percentage of tumor cell involvement | Standard Deviation 1 |
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean) | Caspase (N=55,61) | 0.2 Percentage of tumor cell involvement | Standard Deviation 0.2 |
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean) | VEGF (N=55,61) | 63.7 Percentage of tumor cell involvement | Standard Deviation 38 |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean) | Caspase (N=55,61) | 0.06 Percentage of tumor cell involvement | Standard Deviation 0.08 |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean) | VEGF (N=55,61) | 59.7 Percentage of tumor cell involvement | Standard Deviation 35.4 |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean) | ERβ (N=55,62) | 16.7 Percentage of tumor cell involvement | Standard Deviation 18.8 |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean) | AR (N=54,62) | 68.6 Percentage of tumor cell involvement | Standard Deviation 23.1 |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean) | Ki-67 (N=54,62) | 1.7 Percentage of tumor cell involvement | Standard Deviation 1.4 |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean) | SRD5A2 (N=47,69) | 64.9 Percentage of tumor cell involvement | Standard Deviation 40.8 |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean) | UBE2C (N=55,62) | 0.5 Percentage of tumor cell involvement | Standard Deviation 0.4 |
Secondary
Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups
Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. P values are based on non-parametric Wilcoxon rank-sum test.
Time frame: At prostatectomy following maximum 6 week treatment period.
Population: Of total 94 enrolled participants in the Placebo Arm, 68 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups | Ki-67 (N=54,62) | 1.3 Percentage of tumor cell involvement |
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups | ERβ (N=55,62) | 6.6 Percentage of tumor cell involvement |
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups | AR (N=54,62) | 78.3 Percentage of tumor cell involvement |
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups | SRD5A2 (N=47,69) | 90 Percentage of tumor cell involvement |
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups | UBE2C (N=55,62) | 0.3 Percentage of tumor cell involvement |
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups | Caspase (N=55,61) | 0.08 Percentage of tumor cell involvement |
| Arm I (Finasteride) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups | VEGF (N=55,61) | 90 Percentage of tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups | VEGF (N=55,61) | 70 Percentage of tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups | UBE2C (N=55,62) | 0.3 Percentage of tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups | ERβ (N=55,62) | 9.5 Percentage of tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups | AR (N=54,62) | 75.9 Percentage of tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups | Ki-67 (N=54,62) | 1.4 Percentage of tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups | Caspase (N=55,61) | 0.04 Percentage of tumor cell involvement |
| Arm II (Placebo) | Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups | SRD5A2 (N=47,69) | 90 Percentage of tumor cell involvement |
Comparison: VEGF3, Within Placebo Armp-value: 0.32Wilcoxon (Mann-Whitney)
Comparison: ERβ, Within Placebo Armp-value: 0.83Wilcoxon (Mann-Whitney)
Comparison: AR, Within Placebo Armp-value: 0.77Wilcoxon (Mann-Whitney)
Comparison: Ki-67 protein, Within Placebo Armp-value: 0.87Wilcoxon (Mann-Whitney)
Comparison: SRD5A2, Within Placebo Armp-value: 0.91Wilcoxon (Mann-Whitney)
Comparison: UBE2C, Within Placebo Armp-value: 0.9Wilcoxon (Mann-Whitney)
Comparison: Caspase, Within Placebo Armp-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci
Diagnosis of a small focus of prostatic adenocarcinoma on a prostate needle biopsy from pathologist's identification of an architecturally abnormal focus of epithelial structures at rather low magnification.
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
Population: Analysis includes all evaluable participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci | >/= 5 Foci | 15 participants |
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci | 1 Focus | 15 participants |
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci | 2 Foci | 18 participants |
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci | 3 Foci | 28 participants |
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci | 4 Foci | 13 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci | 4 Foci | 20 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci | 3 Foci | 28 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci | 1 Focus | 11 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci | >/= 5 Foci | 15 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci | 2 Foci | 20 participants |
Secondary
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Primary)
Frequency of Grade 3 and Grade 4 tumors in two treatment groups: Participants consist of men with adenocarcinoma of the prostate, clinical stage T1c or T2, with a Gleason score of 6 or 7 and a PSA level \< 10 ng/mL, who are scheduled to undergo prostatectomy.
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
Population: Analysis includes all evaluable participants. One participant in each arm was excluded due to hormonal therapy effect resulting in lack of assignment of Gleason Grade.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Primary) | Grade 3 | 65 participants |
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Primary) | Grade 4 | 23 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Primary) | Grade 3 | 75 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Primary) | Grade 4 | 18 participants |
Secondary
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Secondary)
Frequency of Grade 3, Grade 4 and Grade 5 tumors in two treatment groups: Participants will consist of men with adenocarcinoma of the prostate, clinical stage T1c or T2, with a Gleason score of 6 or 7 and a PSA level \< 10 ng/mL, who are scheduled to undergo prostatectomy.
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
Population: Analysis includes all evaluable participants. One participant in each arm was excluded due to hormonal therapy effect resulting in lack of assignment of Gleason Grade.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Secondary) | Grade 3 | 31 participants |
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Secondary) | Grade 4 | 53 participants |
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Secondary) | Grade 5 | 4 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Secondary) | Grade 3 | 24 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Secondary) | Grade 4 | 64 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Secondary) | Grade 5 | 5 participants |
Secondary
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score
Frequency of Grade 3 and Grade 4 tumors in two treatment groups: Participants consist of men with adenocarcinoma of prostate, clinical stage T1c or T2, with Gleason score of 6 or 7 and PSA level \< 10 ng/mL, who are scheduled to undergo prostatectomy. 2005 International Society of Urological Pathologists recommendations for Gleason scoring (GS) used to grade tumors based upon its microscopic appearance: a primary grade is assigned to most common tumor pattern, and a second grade to next most common tumor pattern. Gleason score (GS) is sum of the two Gleason grades, based on scale of 2-10 with lowest numbers indicating slow-growing tumor unlikely to spread and highest numbers indicating an aggressive tumor. Gleason grade = 1-5; Gleason score = 2-10; 5 and 10 indicate worst prognosis. American Joint Committee on Cancer (AJCC) staging describes extent of disease progression utilizing TNM scoring system: Tumor size, Lymph Nodes affected, Metastases. Higher stage cancers are more advanced.
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
Population: Analysis includes all evaluable participants. One participant in each arm was excluded due to hormonal therapy effect resulting in lack of assignment of Gleason Grade.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score | Gleason Score 8 | 2 participants |
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score | Gleason Score 9 | 3 participants |
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score | Gleason Score 6 | 12 participants |
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score | Gleason Score 7 | 71 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score | Gleason Score 7 | 78 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score | Gleason Score 8 | 1 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score | Gleason Score 6 | 10 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score | Gleason Score 9 | 4 participants |
Secondary
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Upgrade Between Biopsy and Prostatectomy
Change in Gleason Score from biopsy to prostatectomy where an upgrade refers to a higher Gleason Score signifying worsening of tumor. Gleason scoring (GS) to based on microscopic appearance using 2005 International Society of Urological Pathologists recommendation.
Time frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period
Population: Analysis includes all evaluable participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Upgrade Between Biopsy and Prostatectomy | No | 63 participants |
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Upgrade Between Biopsy and Prostatectomy | Yes | 26 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Upgrade Between Biopsy and Prostatectomy | No | 70 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Upgrade Between Biopsy and Prostatectomy | Yes | 24 participants |
Secondary
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Lymph Node Status
Status of cancer spread to lymph nodes; PN0 Cancer that has not spread to the lymph nodes. Cancer that has not spread to the lymph nodes. The N category describes whether the cancer has spread into nearby lymph nodes. NX means the nearby lymph nodes cannot be evaluated. N0 means nearby lymph nodes do not contain cancer. Numbers after the N (such as N1, N2, and N3) describe the size, location, and/or the number of nearby lymph nodes affected by cancer. The higher the N number, the greater the cancer spread to nearby lymph nodes.
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
Population: Analysis includes all evaluable participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Lymph Node Status | PN0 | 46 participants |
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Lymph Node Status | PN1 | 2 participants |
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Lymph Node Status | pNX | 41 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Lymph Node Status | PN0 | 43 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Lymph Node Status | PN1 | 2 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Lymph Node Status | pNX | 49 participants |
Secondary
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Margin of Resection (MOR)
Edge or border of tissue removed in cancer surgery. The margin is described as negative or clean when the pathologist finds no cancer cells at the edge of the tissue, suggesting that all of the cancer has been removed. The margin is described as positive or involved when the pathologist finds cancer cells at the edge of the tissue, suggesting that all of the cancer has not been removed.
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
Population: Analysis includes all evaluable participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Margin of Resection (MOR) | Positive | 17 participants |
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Margin of Resection (MOR) | Negative | 67 participants |
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Margin of Resection (MOR) | Equivocal | 5 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Margin of Resection (MOR) | Positive | 16 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Margin of Resection (MOR) | Negative | 76 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Margin of Resection (MOR) | Equivocal | 2 participants |
Secondary
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor, Node, Metastasis (TNM) Stage
American Joint Committee on Cancer (AJCC) system 6th edition (2002) describing amount and spread of cancer body, using TNM. T describes the size of the tumor and any spread of cancer into nearby tissue; N describes spread of cancer to nearby lymph nodes; and M describes metastasis (spread of cancer to other parts of the body). Numbers after the T (such as T1, T2, T3, and T4) describe tumor size and/or amount of spread into nearby structures. The higher the T number, the larger the tumor and/or the more it has grown into nearby tissues where T3a reflects tumor has spread through the capsule on one or both sides; and T3b reflects tumor has invaded one or both seminal vesicles.
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
Population: All evaluable participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor, Node, Metastasis (TNM) Stage | pT2 | 73 participants |
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor, Node, Metastasis (TNM) Stage | pT3a | 11 participants |
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor, Node, Metastasis (TNM) Stage | pT3b | 5 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor, Node, Metastasis (TNM) Stage | pT2 | 74 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor, Node, Metastasis (TNM) Stage | pT3a | 15 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor, Node, Metastasis (TNM) Stage | pT3b | 5 participants |
Secondary
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor Volume (Cubic Centimeter)
Characteristics of tumor considering total zone cancer volume, and cancer volume using zonal foci categorized as: PZ, peripheral zone; TZ, transition zone; CZ, central zone.
Time frame: Baseline biopsy to prostatectomy following maximum 6 week treatment period
Population: Analysis includes all evaluable participants.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor Volume (Cubic Centimeter) | Total | 1.0 cubic centimeter |
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor Volume (Cubic Centimeter) | PZ Cancer focus/foci | 0.6 cubic centimeter |
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor Volume (Cubic Centimeter) | TZ cancer focus/foci | 0.0 cubic centimeter |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor Volume (Cubic Centimeter) | Total | 0.8 cubic centimeter |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor Volume (Cubic Centimeter) | PZ Cancer focus/foci | 0.5 cubic centimeter |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor Volume (Cubic Centimeter) | TZ cancer focus/foci | 0.0 cubic centimeter |
Secondary
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin -- Dominant Tumor Focus
Dominant tumor focus, distribution within zones of the prostate using radical prostatectomy specimen (RPS) where number of foci categorized by zone defined as: PZ, peripheral zone; TZ, transition zone; CZ, central zone. Dominant tumor focus is the largest, index lesion, single high risk focus of the prostate cancer.
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
Population: Analysis includes all evaluable participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin -- Dominant Tumor Focus | PZ | 67 participants |
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin -- Dominant Tumor Focus | TZ | 22 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin -- Dominant Tumor Focus | PZ | 73 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin -- Dominant Tumor Focus | TZ | 21 participants |
Secondary
Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS)
Tumor distribution within zones of the prostate using radical prostatectomy specimen (RPS) where number of foci categorized by zone defined as: PZ, peripheral zone; TZ, transition zone; CZ, central zone.
Time frame: Assessment following maximum 6 week treatment period and prostatectomy
Population: Analysis includes all evaluable participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS) | PZ + TZ | 49 participants |
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS) | PZ + CZ | 0 participants |
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS) | PZ + TZ + CZ | 2 participants |
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS) | TZ | 3 participants |
| Arm I (Finasteride) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS) | PZ | 35 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS) | TZ | 3 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS) | PZ | 38 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS) | PZ + TZ | 50 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS) | PZ + TZ + CZ | 2 participants |
| Arm II (Placebo) | Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS) | PZ + CZ | 1 participants |