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

Condition(s) targeted: Enlarged Prostate

Intervention: Finasteride (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: University Health Network, Toronto

Official(s) and/or principal investigator(s):
Antonio Finelli, MD MSc FRCSC, Principal Investigator, Affiliation: University Health Network, Toronto

Overall contact:
Keri L Durrant, BSc., Phone: 416-946-4501, Ext: 3431, Email: keri.durrant@uhn.on.ca

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.

Official title: A Phase III, Randomized, Double-Blind, Placebo Controlled Trial of PROSCAR in Men With Initial Negative Prostate Biopsies

Study design: Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

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

Secondary outcome:

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

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

TRUS nodule detection/visibility.

Prostate vascularity as detected by Doppler ultrasound.

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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.

Keri L Durrant, BSc., Phone: 416-946-4501, Ext: 3431, Email: keri.durrant@uhn.on.ca

University Health Network, Princess Margaret Hospital, Toronto, Ontario M5G 2M9, Canada; Recruiting

Related publications:

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.

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. 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.

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.

Starting date: February 2008
Ending date: January 2010
Last updated: November 20, 2008