Prostate Cancer
Conditions
Keywords
stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
Brief summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Docetaxel may make tumor cells more sensitive to radiation therapy. Giving docetaxel together with radiation therapy and prednisone after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving docetaxel together with radiation therapy and prednisone works in treating patients who have undergone surgery for prostate cancer.
Detailed description
OBJECTIVES: Primary * Determine the rate of prostate-specific antigen (PSA) decline and the number of patients reaching a PSA nadir of zero after treatment with chemoradiotherapy comprising docetaxel and external-beam radiotherapy followed by docetaxel and prednisone in patients with hormone-naive prostate cancer who have a persistent or rising PSA after radical prostatectomy. Secondary * Determine the tolerability of this regimen in these patients. * Determine the progression-free survival, based on PSA progression, of these patients. * Determine the overall survival of patients treated with chemoradiotherapy for rising PSA after radical prostatectomy. * Determine if the velocity of subsequent PSA failure impacts survival of these patients. Tertiary * Document subsequent therapy for patients whose previous treatment has failed and if there is a response to that therapy. Quaternary: To collect data on a contemporary cohort to those on study that received radiation alone. We will match cancer and patient characteristics to determine if the variable of chemotherapy has any impact on outcomes. OUTLINE: Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, 36, and 43 and undergo external-beam radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47. Beginning within 6 weeks after completion of chemoradiotherapy, patients receive docetaxel IV over 1 hour on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 1 month, every 4 months for 2 years, and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Interventions
DRUGdocetaxel
Docetaxel 20mg/m2/week IV every week during standard of care radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.
DRUGprednisone
Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.
PROCEDURERadical prostatectomy
Radical prostatectomy as part of standard care
RADIATIONRadiation therapy
Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions.
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed prostate cancer * Prostate-specific antigen (PSA) level \> 0.2 ng/mL after radical prostatectomy performed ≥ 6 weeks ago * No lymph node-positive prostate cancer * No documented metastatic disease * CT scan of the abdomen and pelvis negative (within the past 6 months) * No bone pain OR negative bone scan (within the past 6 months) * ECOG performance status 0-2 * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9 g/dL * Bilirubin normal * ALT and AST ≤ 1.5 times upper limit of normal * Alkaline phosphatase normal * Fertile patients must use effective contraception * No peripheral neuropathy \> grade 1 * No other malignancy within the last 5 years that could affect the diagnosis or assessment of prostate cancer * No serious illness with a life expectancy of \< 5 years * No concurrent medical, psychological, or social circumstance that would preclude study compliance * No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
Exclusion criteria
* No prior orchiectomy * No prior chemotherapy regimen for this disease * No prior pelvic radiotherapy * No pre- or postoperative androgen manipulation, such as luteinizing hormone-releasing hormone agonists, antiandrogens (flutamide, bicalutamide, or nilutamide), or finasteride * Preoperative androgen manipulation for a duration of ≤ 3 months allowed * No prior immunotherapy * No prior strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium, or other systemic radioisotopes * No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) * No concurrent herbal or alternative regimens including, but not limited to, any of the following: * Saw palmetto * PC-SPES * Shark cartilage * No other concurrent investigational agents * No other concurrent chemotherapy, immunotherapy, or hormonal therapy (except for replacement steroids)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Prostate-Specific Antigen (PSA) Decline Reported as the Number of Subjects Reaching a PSA Nadir of Zero Following the Intervention. | 5 years | Subjects were followed after the intervention and monitored for PSA (Prostate Specific Antigen) decline for up to 5 years of follow-up, to determine how many had a decline and reached a PSA nadir of zero.. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival Based on PSA Progression | 5 years | Subjects were monitored for PSA (Prostate Specific Antigen) for up to 5 years of follow-up. |
| Overall Survival | 5 years | — |
| Correlation Between Velocity of Subsequent PSA Failure and Survival | 5 years | — |
Countries
United States
Participant flow
Recruitment details
Enrollment opened on 21 Mar 2006 and closed on 15 Apr 2009. The first subject was consented on 18 May 2007 and the final subject on 14 Apr 2009. Subjects were all enrolled in outpatient clinics and received treatment as outpatients.
Pre-assignment details
Subjects must have histologic diagnosis of prostate cancer and be post prostatectomy. They must have a PSA \> 0.2 ng/ml (verified on 2 separate tests, at least 2 weeks apart). CT abdomen/pelvis and bone scan must be negative. One subject was a screen failure due to CT showed lung mass (not related to prostate cancer).
Participants by arm
| Arm | Count |
|---|---|
| Docetaxel (Single Arm) Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.
Adjuvant therapy: radical prostatectomy as part of standard care
Radiation therapy: Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions. | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Noncompliance with radiation treatment | 1 |
Baseline characteristics
| Characteristic | Docetaxel (Single Arm) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 65 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 12 / 20 |
| other Total, other adverse events | 20 / 20 |
| serious Total, serious adverse events | 12 / 20 |
Outcome results
Primary
Rate of Prostate-Specific Antigen (PSA) Decline Reported as the Number of Subjects Reaching a PSA Nadir of Zero Following the Intervention.
Subjects were followed after the intervention and monitored for PSA (Prostate Specific Antigen) decline for up to 5 years of follow-up, to determine how many had a decline and reached a PSA nadir of zero..
Time frame: 5 years
Population: Exceptions to group description: (1) one subject non-compliant and taken off study (not included in analysis); (2) one subject did not receive docetaxel #7 during radiation due to change in performance status; (3) one subject received only 1 post radiation docetaxel; (4) two subjects did not receive post radiation docetaxel #4.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Docetaxel (Single Arm) | Rate of Prostate-Specific Antigen (PSA) Decline Reported as the Number of Subjects Reaching a PSA Nadir of Zero Following the Intervention. | 12 Participants |
Secondary
Correlation Between Velocity of Subsequent PSA Failure and Survival
Time frame: 5 years
Population: N/A no study data was recorded for this outcome
Secondary
Overall Survival
Time frame: 5 years
Population: N/A no data recorded
Secondary
Progression-free Survival Based on PSA Progression
Subjects were monitored for PSA (Prostate Specific Antigen) for up to 5 years of follow-up.
Time frame: 5 years
Population: One subject was not included in analysis due to taken off study due to non-compliance
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Docetaxel (Single Arm) | Progression-free Survival Based on PSA Progression | 12 Participants |