Trial intelligence / Profile preview

Degarelix for Prostate Downsizing Prior to Brachytherapy

NCT01446991Phase 2

Key facts

Status
Completed
Start
Apr 2012
Primary completion
Feb 2017
Countries
1
Sponsor
BC Cancer
Modality
Peptides, Small Molecules
Conditions
prostate cancer (PCa)
01

Overview

Phase 2, open-label trial of degarelix in prostate cancer (PCa) (2 arms), sponsored by BC Cancer. Primary endpoint: Prostate volume reduction at 3 months. Started Apr 2012; status: completed.

02

Design

2 arms
Study design
Non-randomizedOpen-label
  • Favorable prostate cancer with pubic arch interference

    Men with favorable risk disease requiring downsizing. Degarelix for 2-3 months.

  • Intermediate risk prostate cancer

    Men with intermediate risk disease requiring 6 months androgen ablation. Degarelix for 6 months.

03

Who it enrols

Men with favorable or intermediate risk prostate cancer requiring prostate downsizing or androgen ablation prior to brachytherapy.

04

Endpoints

Primary

  • Prostate volume reduction

Secondary

  • Testosterone recovery

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