A Trial of PROSCAR (Finasteride) Versus Placebo in Men With an Initial Negative Prostate Biopsy
NCT ID: NCT00542243
Last Updated: 2015-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
19 participants
INTERVENTIONAL
2008-02-29
2012-12-31
Brief Summary
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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.
Detailed Description
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5.1.1. Biopsy The TRUS guided biopsy, to be carried out at Visit 4, will be performed by one physician. The biopsy will be performed as per the standard protocol at UHN, including 13-15 cores. The physician performing the biopsy will be blinded to the initial biopsy results and the PSA change over time. Before biopsy, a DRE will be performed. Aside from the standard biopsy scheme, suspicious areas on TRUS can be further biopsied. (e.g. a hypoechoic nodule).
5.2. Methods for Accrual and Randomization: Patients with an initial negative prostate biopsy that was performed at UHN and seen at the Prostate Center of the Princess Margaret Hospital will be considered for enrolment. Randomization by a random numbers table will be performed in blocks of 4 patients. After patients are deemed eligible for the study, the central office at Merck will be contacted and patient assignment given. The code will match the study drug label and the drug shipment will contain a blinded allocation envelope. The investigators, study participants and research coordinators will be blinded to the intervention.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
QUADRUPLE
Study Groups
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Finasteride
The recommended dosage of PROSCAR© is one 5 mg tablet daily with or without food. If a tablet is missed at its usual time, an extra dose should not be taken. The next dose should be taken as usual.
PROSCAR© 5 mg tablets are blue, apple-shaped; film coated with the code MSD 72 on one side and PROSCAR on the other. They will be provided in bottles of 35 tablets.
Finasteride
Finasteride (5mg) will be given once per day for 6 months.
Placebo
Patient will receive a placebo comparator each day for 6 months.
Placebo
Placebo will be given once a day for 6 months.
Interventions
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Finasteride
Finasteride (5mg) will be given once per day for 6 months.
Placebo
Placebo will be given once a day for 6 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
MALE
No
Sponsors
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Merck Frosst Canada Ltd.
INDUSTRY
University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Antonio Finelli, MD MSc FRCSC
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada
Countries
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References
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Kaplan SA, Ghafar MA, Volpe MA, Lam JS, Fromer D, Te AE. PSA response to finasteride challenge in men with a serum PSA greater than 4 ng/ml and previous negative prostate biopsy: preliminary study. Urology. 2002 Sep;60(3):464-8. doi: 10.1016/s0090-4295(02)01760-0.
Handel LN, Agarwal S, Schiff SF, Kelty PJ, Cohen SI. Can effect of finasteride on prostate-specific antigen be used to decrease repeat prostate biopsy? Urology. 2006 Dec;68(6):1220-3. doi: 10.1016/j.urology.2006.08.1070. Epub 2006 Dec 4.
Thompson IM, Chi C, Ankerst DP, Goodman PJ, Tangen CM, Lippman SM, Lucia MS, Parnes HL, Coltman CA Jr. Effect of finasteride on the sensitivity of PSA for detecting prostate cancer. J Natl Cancer Inst. 2006 Aug 16;98(16):1128-33. doi: 10.1093/jnci/djj307.
Thompson IM, Tangen CM, Goodman PJ, Lucia MS, Parnes HL, Lippman SM, Coltman CA Jr. Finasteride improves the sensitivity of digital rectal examination for prostate cancer detection. J Urol. 2007 May;177(5):1749-52. doi: 10.1016/j.juro.2007.01.071.
Other Identifiers
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07-0499-B
Identifier Type: -
Identifier Source: org_study_id
NCT00547079
Identifier Type: -
Identifier Source: nct_alias