Conditions: Prostate Cancer
Keywords: Prostate Cancer Early Stage Prostate Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 16
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the effect of short-term intake of daily Dutasteride in patients with prostate cancer.

Detailed description:
This is a study of men who have undergone a standard 10 or more core biopsy for detection of prostate cancer and determined to have prostate cancer by having a Gleason score ≤ 7 (low to moderate risk 2-7). Of these men, one arm of a two arm randomized group will be administered a treatment regime of Dutasteride versus the control group who receive standard of care, prior to mapping biopsy. This proposal aims at studying the apparent effect of the use of Dutasteride (3 months) on initial tumor volume (at diagnosis) in men with low volume cancer before undergoing 3D mapping biopsy.

Arms:
arm 1: The drug, Dutasteride, will be administered at 0.5 mg dose and given everyday (QD), for 3 months. arm 2: The placebo group will receive a placebo drug for 3 months, instead of the intervention drug, Dutasteride.

Interventions: intervention 1: Dutasteride intervention 2: Placebo
Intervention descriptions: intervention 1: Dutasteride will be administered at 0.5 mg dose and it will be given every day (QD), for approximately 3 months, followed by 3D mapping biopsy. intervention 2: The placebo group will receive the same standard of care as the intervention group, but instead of receiving the intervention drug, Dutasteride, participants will receive a placebo drug for the same 3 month period.

Protocol document: