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Feasibility and Toxicity of Degarelix for Prostate Downsizing Prior to Permanent Seed Prostate Brachytherapy

NCT01446991 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-01-27

No results posted yet for this study

Summary

This study will investigate the efficacy of Degarelix, a Luteinizing Hormone Releasing Hormone (LHRH) antagonist, to reduce prostate volume prior to permanent seed prostate brachytherapy. There are 2 eligible populations of men, all of whom will have selected brachytherapy as their treatment of choice for their prostate cancer. Either they have an enlarged prostate that requires size reduction to render brachytherapy technically feasible, or they require androgen ablation in conjunction with brachytherapy for optimal tumor control. The hypothesis is that Degarelix will provide \> 30% volume reduction by 3 months in \> 30% of men.

Conditions

Interventions

DRUG

Degarelix

240 mg loading dose followed by monthly 80 mg maintenance dose for 2-3 months

DRUG

Degarelix

240 mg loading dose of Degarelix followed by 80 mg maintenance doses every month for a total duration of 6 months.

Sponsors & Collaborators

  • British Columbia Cancer Agency

    lead OTHER

Principal Investigators

  • Juanita M Crook, MD · British Columbia Cancer Agency

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2017-02-28
Completion
2017-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01446991 on ClinicalTrials.gov