Dutasteride in Treating Patients With Prostate Cancer

Phase 2

• Conditions: Prostate Cancer

• Registration Number: NCT01193855
• Lead Sponsor: University College London Hospitals

Brief 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.

Detailed 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 Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-09-01
• Study First Submitted QC: 2010-09-01
• Study First Posted: 2010-09-02
• Status Verified: 2011-08
• Primary Completion: 2012-01
• Last Update Submitted: 2013-08-23
• Last Update Posted: 2013-08-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in volume of foci of prostate cancer (PC) as assessed by T2-weighted (T2w) MRI between baseline and 6 months

Secondary Outcome Measures

Name	Time	Method
The change in volume of PC as determined by T2w MRI, GE MRI, and DW MRI at 3 months
The changes in MR characteristics of PC (perfusion, cell density) between baseline and 6 months
The change in volume of PC as assessed by HistoScan transrectal ultrasound (TRUS) between baseline and 6 months
The association between the measured PC volumes on MRI with the measured PC volumes on TRUS at baseline and 6 months
The association between the measured changes in PC volume using MRI vs TRUS at baseline and 6 months
The association of PC volume change with qualitative changes seen on TRUS between baseline and 6 months
The association between MR changes in volume and characteristics with histological features as seen on 6-month biopsy (Gleason score and sum, number of cores involved, cancer core length)
The change in volume of PC as determined by gadolinium-enhanced (GE) MRI and diffusion-weighted (DW) MRI at 6 months

Trial Locations

Locations (1)

University College of London Hospitals; 🇬🇧 London, England, United Kingdom