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

Sponsor:	University Health Network, Toronto
Collaborator:	Merck Frosst Canada Ltd.
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00542243

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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control 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:

Drug Information available for: Finasteride

U.S. FDA Resources

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 2011
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Finasteride: Active Comparator	Drug: Finasteride Finasteride (5mg) will be given once per day for 6 months.
Placebo: Placebo Comparator 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:

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.

Responsible Party:	University Health Network ( Dr. Antonio Finelli/Urologic Oncologist )
Study ID Numbers:	07-0499-B
Study First Received:	October 9, 2007
Last Updated:	January 21, 2010
ClinicalTrials.gov Identifier:	NCT00542243 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University Health Network, Toronto:

enlarged prostate
finasteride

Additional relevant MeSH terms:

Finasteride
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on March 18, 2010