Dutasteride in Treating Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title: Single Site, Phase II, Double Blind, Randomized, Placebo Controlled Study of the Effect of Dutasteride (Avodart) 0.5mg on the Volume and Characteristics of Prostate Cancer, as Assessed by Multifunctional Magnetic Resonance Imaging (MRI) With Lower Risk Prostate Cancer Suitable for Active Surveillance. (MAPPED TRIAL)

Status Recruiting

Clinical Trial Summary

RATIONALE: Dutasteride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This randomized phase II trial is studying how well giving dutasteride works in treating patients with prostate cancer.

Clinical Trial Description

OBJECTIVES:

Primary

• To evaluate the change in volume of foci of prostate cancer as assessed by T2-weighted MRI, following exposure to dutasteride (Avodart) 0.5 mg daily for six months.

Secondary

• To determine the change in volume of prostate cancer as determined by gadolinium-enhanced MRI and diffusion-weighted MRI after 6 months of dutasteride 0.5 mg compared to placebo.

• To determine the change in volume of prostate cancer as determined by T2-weighted MRI, gadolinium-enhanced MRI, and diffusion-weighted MRI after 3 months of dutasteride compared to placebo.

• To determine the changes in MR characteristics of prostate cancer (perfusion, cell density) between baseline and six months in patients on dutasteride compared to placebo.

• To determine the change in volume of prostate cancer as assessed by HistoScan transrectal ultrasound between baseline and six months, in patients on dutasteride compared to placebo.

• To determine the association between the measured prostate cancer volumes on MRI with the measured prostate cancer volumes on HistoScan at baseline and six months in patients on dutasteride compared to placebo.

• To determine the association between the measured changes in prostate cancer volume using MRI, and the measured changes in prostate cancer volume using HistoScan transrectal ultrasound, at baseline and at six months, in patients on dutasteride compared to placebo.

• To correlate changes in tumor volume and characteristics seen on MRI with changes seen on HistoScan between baseline and six months in patients on dutasteride compared to placebo.

• To correlate change in tumor volume and characteristics seen on MRI with histological features as seen on 6-month biopsy (Gleason score and sum, number of cores involved, cancer core length) in patients on dutasteride compared to placebo.

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

• Arm I: Patients receive oral dutasteride once daily for 6 months. Treatment continues in the absence of unacceptable toxicity.

• Arm II: Patients receive oral placebo once daily for 6 months. Treatment continues in the absence of unacceptable toxicity.

Patients undergo a multi-sequence MRI at baseline, 3 months, and 6 months and HistoScan transrectal ultrasound at baseline and 6 months. Patients may also undergo a targeted biopsy of the prostate (standard transrectal biopsy plus ultrasound-guided targeting of lesions seen on MRI) at 6 months. ;

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT01193855
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Recruiting
• Phase: Phase 2
• Start date: June 2010