A Trial of PROSCAR (Finasteride) Versus Placebo in Men With an Initial Negative Prostate Biopsy (Prostress)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University Health Network, Toronto.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Health Network, Toronto
Collaborator:
Merck Frosst Canada Ltd.
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00542243
First received: October 9, 2007
Last updated: May 12, 2011
Last verified: May 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to assess whether six months of daily finasteride (PROSCAR), following an initial negative prostate biopsy, will improve the detection of prostate cancer on repeat biopsy.
144 subjects with an initial negative prostate biopsy will be randomized to receive either finasteride or placebo for 6 months. The subjects will undergo a second prostate biopsy following drug intervention. PSA (prostate specific antigen) measurements, testosterone levels, and quality of life questionnaires will also be assessed during the study. The two groups will then be compared.
| Condition | Intervention | Phase |
|---|---|---|
|
Enlarged Prostate |
Drug: Finasteride Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic |
| Official Title: | A Phase III, Randomized, Double-Blind, Placebo Controlled Trial of PROSCAR in Men With Initial Negative Prostate Biopsies |
Resource links provided by NLM:
Further study details as provided by University Health Network, Toronto:
Primary Outcome Measures:
- The rate of prostate cancer at repeat TRUS (Transrectal Ultrasound) guided biopsy after 6 months of therapy with Finasteride/placebo. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in PSA parameters over time: a. PSA velocity b. PSA density c. Free/total PSA. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- TRUS at baseline and at the 6-month biopsy will be used to measure the total gland and transition zone volumes. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- TRUS nodule detection/visibility. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Prostate vascularity as detected by Doppler ultrasound. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Quality of life as tested by the IPSS (International Prostate Symptom Score). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 144 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Finasteride |
Drug: Finasteride
Finasteride (5mg) will be given once per day for 6 months.
Other Name: PROSCAR
|
|
Placebo Comparator: Placebo
Patient will receive a placebo comparator each day for 6 months.
|
Drug: Placebo
Placebo will be given once a day for 6 months.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Initial biopsy, performed at UHN, of at least 8 cores with no evidence of cancer (HGPIN or ASAP allowed)
- PSA < 20 ng/ml
- Able to swallow and retain oral medication
- Able to read and write (IPSS questionnaire is self-administered), understand instructions related to study procedures and to give written informed consent.
Exclusion Criteria:
- Glucocorticoids, except inhaled or topical, are not permitted within 3 months prior to visit one.
- Concurrent and previous use within the past 12 months of the following medications: Finasteride (PROSCAR, Propecia), Dutasteride (Avodart), Any other investigational 5 alpha-reductase inhibitors, Anabolic steroids, drugs with antiandrogenic properties.
- Participation in an investigational or marketed drug trial within the 30 days prior to the first dose of study drug or anytime during the study period.
- Abnormal liver function test (greater than 2 times the upper limit of normal) for alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase; or bilirubin > 1.5 times the upper limit of normal.
- Serum creatinine > 1.5 times the upper limit of normal.
- Any unstable serious co-existing medical conditions including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.
- History of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject.
- Known hypersensitivity to any 5 alpha-reductase inhibitor or to any drug chemically related to finasteride.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00542243
Contacts
| Contact: Keri L Durrant, BSc., PGCR, CCRP | 416-946-4501 ext 3431 | keri.durrant@uhn.on.ca |
| Contact: Hersey Karen, RN | 416-946-2155 | karen.hersey@uhn.on.ca |
Locations
| Canada, Ontario | |
| University Health Network, Princess Margaret Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
Sponsors and Collaborators
University Health Network, Toronto
Merck Frosst Canada Ltd.
Investigators
| Principal Investigator: | Antonio Finelli, MD MSc FRCSC | University Health Network, Toronto |
More Information
Publications:
| Responsible Party: | Dr. Antonio Finelli/Urologic Oncologist, University Health Network |
| ClinicalTrials.gov Identifier: | NCT00542243 History of Changes |
| Obsolete Identifiers: | NCT00547079 |
| Other Study ID Numbers: | 07-0499-B |
| Study First Received: | October 9, 2007 |
| Last Updated: | May 12, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University Health Network, Toronto:
|
enlarged prostate finasteride |
Additional relevant MeSH terms:
|
Finasteride 5-alpha Reductase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013