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

This study has been completed.
Sponsor:
Collaborator:
Merck Frosst Canada Ltd.
Information provided by (Responsible Party):
Antonio (Tony) Finelli, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00542243
First received: October 9, 2007
Last updated: December 10, 2013
Last verified: December 2013
  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 ]

Enrollment: 19
Study Start Date: February 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.

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.

Detailed Description:

5.0. Study Design and Treatment 5.1. Study Design This is a randomized, two-arm, double blind, placebo controlled study of daily PROSCAR® or placebo for 6 months in men with an initial negative prostate biopsy.

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542243

Locations
Canada, Ontario
University Health Network, Princess Margaret Hospital
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: Antonio (Tony) Finelli, MD, MSc, FRCSC, University Health Network, Toronto
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: December 10, 2013
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
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on October 21, 2014