Trial record 5 of 41 for:
prostate cancer screening | Open Studies
3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer
This study is currently recruiting participants.
(see Contacts and Locations)
Verified February 2014 by The University of Texas Health Science Center at San Antonio
Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborators:
Information provided by (Responsible Party):
Ian Thompson, Jr., The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01296672
First received: February 3, 2011
Last updated: February 8, 2014
Last verified: February 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: Finasteride |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Screening |
| Official Title: | Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test |
Resource links provided by NLM:
Further study details as provided by The University of Texas Health Science Center at San Antonio:
Primary Outcome Measures:
- Determine if finasteride improves the Prostate Specific Antigen (PSA) and the Digital Rectal Exam (DRE) for prostate cancer screening by reducing the PSA and the size of the prostate. [ Time Frame: 3 months ] [ Designated as safety issue: No ]Participants will take Finasteride/Placebo 5mg per day by mouth for 3 months before prostate biopsy.
| Estimated Enrollment: | 500 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Finasteride
Finasteride 5mg tablets every day by mouth for 3 months
|
Drug: Finasteride
Finasteride 5mg every day by mouth for 3 months
Other Names:
|
|
Placebo Comparator: Placebo
Placebo 5mg tablet every day by mouth for 3 months
|
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.
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
- Patient has been recommended to undergo and plans to have a prostate biopsy.
- Patient is willing to delay prostate biopsy for a 3-month finasteride vs placebo treatment.
- No allergy to finasteride or other five alpha reductase inhibitors.
- Patient is willing to take finasteride vs placebo 5 mg orally daily for 3-month treatment period.
- Age 55 or older. (This age is selected as the PCPT risk calculator is only valid for this age range.)
Exclusion Criteria:
- Risk of cancer greater than 60% or less than 20%.
- Prior history of prostate cancer.
- Prior treatment with finasteride or dutasteride in the past 6 months
- Younger than age 55.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296672
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296672
Contacts
| Contact: Joseph Long | (210) 450-0705 | longj4@uthscsa.edu |
Locations
| United States, Texas | |
| The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Joseph Long 210-450-0705 longj4@uthscsa.edu | |
| Principal Investigator: Javier Hernandez, MD | |
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
| Principal Investigator: | Javier Hernandez, MD | The University of Texas Health Science Center at San Antonio |
More Information
No publications provided
| Responsible Party: | Ian Thompson, Jr., Professor, The University of Texas Health Science Center at San Antonio |
| ClinicalTrials.gov Identifier: | NCT01296672 History of Changes |
| Other Study ID Numbers: | ROI10-352, R01CA138627 |
| Study First Received: | February 3, 2011 |
| Last Updated: | February 8, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The University of Texas Health Science Center at San Antonio:
|
Finasteride Placebo Prostate cancer |
Prostate Specific Antigen (PSA) Men at intermediate risk of prostate cancer Men scheduled for prostate biopsy |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Neoplasms Genital Diseases, Male |
Finasteride 5-alpha Reductase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses Urological Agents |
ClinicalTrials.gov processed this record on March 01, 2015