A Trial of PROSCAR (Finasteride) Versus Placebo in Men With an Initial Negative Prostate Biopsy

NCT00542243 | Completed Phase 3

• 1 other identifier: 07-0499-B
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Enlarged Prostate

Keywords

enlarged prostate; finasteride

Outcome Measures

Primary Outcomes (1)

• The rate of prostate cancer at repeat TRUS (Transrectal Ultrasound) guided biopsy after 6 months of therapy with Finasteride/placebo.

  6 months

Secondary Outcomes (5)

• Change in PSA parameters over time: a. PSA velocity b. PSA density c. Free/total PSA.

  6 months

• TRUS at baseline and at the 6-month biopsy will be used to measure the total gland and transition zone volumes.

  6 months

• TRUS nodule detection/visibility.

  6 months

• Prostate vascularity as detected by Doppler ultrasound.

  6 months

• Quality of life as tested by the IPSS (International Prostate Symptom Score).

  6 months

Study Arms (2)

Finasteride

ACTIVE COMPARATOR

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.

Drug: Finasteride

Placebo

PLACEBO COMPARATOR

Patient will receive a placebo comparator each day for 6 months.

Drug: Placebo

Interventions

Finasteride DRUG

Finasteride (5mg) will be given once per day for 6 months.

Also known as: PROSCAR

Finasteride

Placebo DRUG

Placebo will be given once a day for 6 months.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Merck Frosst Canada Ltd.: collaborator

Study Sites (1)

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (4)

• 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.

  PMID: 12350485 BACKGROUND

• 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.

  PMID: 17141826 BACKGROUND

• 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.

  PMID: 16912265 BACKGROUND

• 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.

  PMID: 17437804 BACKGROUND

MeSH Terms

Interventions

Finasteride

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic

Study Officials

• Antonio Finelli, MD MSc FRCSC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2007
• First Posted: October 11, 2007
• Study Start: February 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 9, 2015

Record last verified: 2015-12

Locations

CA (1)