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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA138627 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Finasteride | Experimental | Finasteride 5mg tablets every day by mouth for 3 months |
|
| Placebo | Placebo Comparator | Placebo 5mg tablet every day by mouth for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Finasteride | Drug | Finasteride 5mg every day by mouth for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Reported at 90-days: assessment at baseline, 1 month, 2 months and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Reported at 90 days: assessed at baseline, 30 days, 60 days and 90-day |
| T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score AUC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javier Hernandez, MD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30300367 | Derived | Hernandez J, Gelfond J, Goros M, Liss MA, Liang Y, Ankerst D, Thompson IM Jr, Leach RJ. The effect of 3-month finasteride challenge on biomarkers for predicting cancer outcome on biopsy: Results of a randomized trial. PLoS One. 2018 Oct 9;13(10):e0204823. doi: 10.1371/journal.pone.0204823. eCollection 2018. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Finasteride | Finasteride 5mg every day by mouth for 3 months |
| FG001 | Placebo | Placebo every day by mouth for 3 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Finasteride | Finasteride 5mg tablets every day by mouth for 3 months Finasteride: Finasteride 5mg every day by mouth for 3 months |
| BG001 | Placebo | Placebo 5mg tablet every day by mouth for 3 months Placebo: Placebo every day by mouth for 3 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Patients with biopsy | Posted | Number | 95% Confidence Interval | Ratio | Reported at 90-days: assessment at baseline, 1 month, 2 months and 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Finasteride | Finasteride 5mg every day by mouth for 3 months | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fulgurated skin lesions | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Skin Lesions/tags with itching--fulgurated |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Gelfond | UT Health | 210 567-0836 | gelfondjal@uthscsa.edu |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D018120 | Finasteride |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo | Drug | Placebo every day by mouth for 3 months |
|
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 |
| Reported at 90 days: assessed at baseline, 30 days, 60 days, and 90 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Prostate Specific Antigen | Median | Inter-Quartile Range | ng/ml |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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) | Receiving biopsy | Posted | Number | 95% Confidence Interval | ratio | Reported at 90 days: assessed at baseline, 30 days, 60 days and 90-day |
|
|
|
| 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 | Receiving biopsy | Posted | Number | 95% Confidence Interval | Ratio | Reported at 90 days: assessed at baseline, 30 days, 60 days, and 90 days |
|
|
|
| 306 |
| 3 |
| 306 |
| 7 |
| 306 |
| EG001 | Placebo | Placebo every day by mouth for 3 months | 0 | 77 | 1 | 77 | 6 | 77 |
|
| Palpitations | Cardiac disorders | Non-systematic Assessment | "prob" palipitations" heart fluttering X2 seconds |
|
| Dizziness | Ear and labyrinth disorders | Non-systematic Assessment | Morning dizziness while in bed and better when gets out of bed |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment | Severe abdominal pain |
|
| Decreased libido | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | Non-systematic Assessment |
|
| Itch | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Stent placement | Vascular disorders | Non-systematic Assessment |
|
| Syncope | Cardiac disorders | Non-systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011083 |
| Polycyclic Compounds |
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |