Finasteride Before Prostate Biopsy in Screening Patients For Prostate Cancer

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Basic Trial Information

PhaseTypeAgeTrial IDs
No phase specifiedPrevention55 and overHSC20100352H
NCI-2012-02003, CTRC 20100352H, RO1CA138627, NCT01296672

Trial Description

Summary

This clinical trial studies finasteride before prostate biopsy in screening patients for prostate cancer. Screening tests may help doctors find cancer cells early and plan better treatment for prostate cancer. Giving finasteride may result in more accurate prostate-specific antigen (PSA) testing by shrinking non-cancerous prostate tissue.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine if a five alpha reductase 'challenge' with finasteride improves the performance of the combination of PSA and digital rectal examination (DRE) in men who are scheduled for prostate biopsy.

SECONDARY OBJECTIVES:

I. To evaluate the independent predictive value of other prostate cancer markers including prostate cancer antigen 3 (PCA3), transmembrane protease, serine 2 (TMPRSS2):v-ets erythroblastosis virus E26 oncogene homolog (ERG), and 3-month finasteride PSA velocity on the performance of the Prostate Cancer Prevention Trial (PCPT) risk calculator.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive finasteride orally (PO) once daily (QD) for 3 months, and then undergo prostate biopsy at 90 days.

ARM II: Patients receive placebo PO QD for 3 months, and then undergo prostate biopsy at 90 days.

Eligibility Criteria

Inclusion Criteria:

Risk of prostate cancer 20-60% calculated with the on-line PCPT prostate cancer risk calculator; PSA value must be obtained within 3 months prior to study entry

No allergy to finasteride or other five alpha reductase inhibitors

Patient is willing to take finasteride 5 mg orally daily for 3-month treatment period

Patient is willing to delay prostate biopsy for a 3-month finasteride treatment

Patient has been recommended to undergo and plans to have a prostate biopsy

Exclusion Criteria:

Prior treatment with finasteride or dutasteride in the past 6 months

Prior history of prostate cancer

Risk of cancer greater than 60% or less than 20%

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

University of Texas Health Science Center at San Antonio

  • National Cancer Institute
Javier Hernandez, Principal Investigator

Trial Sites

U.S.A.

Texas
San Antonio

University of Texas Health Science Center at San Antonio

Javier Hernandez
Ph: 210-567-5676
Email: hernandezj7@uthscsa.edu

Javier Hernandez
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01296672

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.