Prostate Cancer
Conditions
Keywords
Finasteride, Placebo, Prostate cancer, Prostate Specific Antigen (PSA), Men at intermediate risk of prostate cancer, Men scheduled for prostate biopsy
Brief summary
The investigators will propose a novel method to improve prostate cancer screening with PSA, using a 3-month treatment with finasteride, a drug used to treat Benign Prostatic Hyperplasia (BPH) and proven to reduce a man's risk of developing prostate cancer. The investigators will also examine three additional promising tests that may further improve diagnosis of prostate cancer.
Detailed description
The primary goal of this proposal is to determine if a 5-alpha reductase 'challenge' improves screening performance of PSA and DRE in men who are scheduled for prostate biopsy. Currently a higher PSA level leads to a recommendation for prostate biopsy, causing hundreds of thousands of unnecessary biopsies annually in the U.S. We will show that a three-month treatment with finasteride for men with high PSA levels will better predict the man who should have a prostate biopsy. PSA performance after finasteride 'challenge' will also be compared with new tests for prostate cancer. Finasteride is supplied by Merck and Company, Incorporated.
Interventions
DRUGFinasteride
Finasteride 5mg every day by mouth for 3 months
DRUGPlacebo
Placebo every day by mouth for 3 months
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Risk of prostate cancer 20-60% calculated with the on-line Prostate Cancer Prevention Trial (PCPT) prostate cancer risk calculator. (www.prostate-cancer-risk-calculator.com). PSA value must be obtained within 3 months prior to study entry. A description of the frequency of these individuals in the population is provided in Specific Aim 2 2. Patient has been recommended to undergo and plans to have a prostate biopsy. 3. Patient is willing to delay prostate biopsy for a 3-month finasteride vs placebo treatment. 4. No allergy to finasteride or other five alpha reductase inhibitors. 5. Patient is willing to take finasteride vs placebo 5 mg orally daily for 3-month treatment period. 6. Age 55 or older. (This age is selected as the PCPT risk calculator is only valid for this age range.)
Exclusion criteria
1. Risk of cancer greater than 60% or less than 20%. 2. Prior history of prostate cancer. 3. Prior treatment with finasteride or dutasteride in the past 6 months 4. Younger than age 55.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre/Post Ratio PSA Area Under the Curve (AUC) | Reported at 90-days: assessment at baseline, 1 month, 2 months and 3 months | Pre/Post Ratio prediction area under the receiver operating characteristics curve (AUC) for subjects taking finasteride 5mg every day for 3 months. Measurements of PSA are measured from Baseline until 3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PCA3 (Prostate Cancer Antigen 3)Score AUC | Reported at 90 days: assessed at baseline, 30 days, 60 days and 90-day | Area under the Receiver Operating Characteristic Curve (ROC-AUC) of the PCA3 (Prostate Cancer Antigen 3) to detect difference in PSA decline between cases and controls (non-cases) |
| T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score AUC | Reported at 90 days: assessed at baseline, 30 days, 60 days, and 90 days | Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score to Predict the Risk of Prostate Cancer |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Finasteride Finasteride 5mg tablets every day by mouth for 3 months
Finasteride: Finasteride 5mg every day by mouth for 3 months | 306 |
| Placebo Placebo 5mg tablet every day by mouth for 3 months
Placebo: Placebo every day by mouth for 3 months | 77 |
| Total | 383 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 73 | 18 |
Baseline characteristics
| Characteristic | Finasteride | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 65 years | 66 years | 65 years |
| Prostate Specific Antigen | 5.2 ng/ml | 5.3 ng/ml | 5.2 ng/ml |
| Race/Ethnicity, Customized Race Hispanic | 134 Participants | 34 Participants | 168 Participants |
| Race/Ethnicity, Customized Race Non-Hispanic black | 42 Participants | 12 Participants | 54 Participants |
| Race/Ethnicity, Customized Race Non-Hispanic white | 125 Participants | 31 Participants | 156 Participants |
| Race/Ethnicity, Customized Race Other race | 5 Participants | 0 Participants | 5 Participants |
| Region of Enrollment United States | 306 participants | 77 participants | 383 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 306 Participants | 77 Participants | 383 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 306 | 0 / 77 |
| other Total, other adverse events | 7 / 306 | 6 / 77 |
| serious Total, serious adverse events | 3 / 306 | 1 / 77 |
Outcome results
Primary
Pre/Post Ratio PSA Area Under the Curve (AUC)
Pre/Post Ratio prediction area under the receiver operating characteristics curve (AUC) for subjects taking finasteride 5mg every day for 3 months. Measurements of PSA are measured from Baseline until 3 months.
Time frame: Reported at 90-days: assessment at baseline, 1 month, 2 months and 3 months
Population: Patients with biopsy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Finasteride | Pre/Post Ratio PSA Area Under the Curve (AUC) | 0.57 Ratio |
| Placebo | Pre/Post Ratio PSA Area Under the Curve (AUC) | 0.61 Ratio |
Secondary
PCA3 (Prostate Cancer Antigen 3)Score AUC
Area under the Receiver Operating Characteristic Curve (ROC-AUC) of the PCA3 (Prostate Cancer Antigen 3) to detect difference in PSA decline between cases and controls (non-cases)
Time frame: Reported at 90 days: assessed at baseline, 30 days, 60 days and 90-day
Population: Receiving biopsy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Finasteride | PCA3 (Prostate Cancer Antigen 3)Score AUC | 0.65 ratio |
| Placebo | PCA3 (Prostate Cancer Antigen 3)Score AUC | 0.84 ratio |
Secondary
T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score AUC
Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score to Predict the Risk of Prostate Cancer
Time frame: Reported at 90 days: assessed at baseline, 30 days, 60 days, and 90 days
Population: Receiving biopsy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Finasteride | T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score AUC | 0.62 Ratio |
| Placebo | T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score AUC | 0.62 Ratio |