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Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT01446991 (opens ClinicalTrials.gov in a new tab)Other idH11-08172
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
50 participants (actual)
Sponsor
British Columbia Cancer Agency · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

Canada

Start
Apr 2012
Primary completion
Feb 2017
Completion
Dec 2017
First posted
5 Oct 2011 (estimated)
Last update posted
27 Jan 2020
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201320142015201620172018
  1. Ph 2

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

    NCT01446991

    Apr 2012 to Dec 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • DegarelixDrug
  • DegarelixDrug

Arms2

  • Experimental

    Favorable prostate cancer with pubic arch interference

    Men in this arm have chosen brachytherapy for management of localized prostate cancer and do not require androgen ablation for oncologic reasons but have an enlarged prostate causing pubic arch interference and thus require prostate size reduction prior to brachytherapy. They will have 2-3 months of Degarelix with measurement of prostate volume at 8 and 12 weeks.

  • Experimental

    Intermediate risk prostate cancer, 6 months Degarelix

    Men in this arm have higher risk prostate cancer (upper tier intermediate risk by National Comprehensive Cancer Network \[NCCN\] guidelines) and require 6 months of androgen ablation in conjunction with brachytherapy. Prostate size must be \> 40 cc at baseline so that prostate size reduction measurements are appropriate. Prostate measurements by transrectal ultrasound with be taken at 12 weeks and 20 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. prostate volume reduction

    Time frame · 3 months

    Registry description

    determined by transrectal ultrasound with planimetry volume calculation

Secondary outcomes(1)

  1. testosterone recovery

    Time frame · 12 months

    Registry description

    Luteinizing Hormone(LH), Follicle Stimulating Hormone (FSH) and testosterone will be measured at 1, 3, 6, 9 and 12 months following cessation of Degarelix.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2018

4 results

A Phase II trial of 8 weeks of degarelix for prostate volume reduction: Efficacy and hormonal recovery.

Korzeniowski et al. 2018Brachytherapycited by 3

PMID 29398594DOI 10.1016/j.brachy.2017.12.005PUB-29398594

Full text at the publisher4 results
Publisher pageSee results (4)

Eligibility

Who could join, as posted.

Sex
Male
Age
from 40 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Histologic diagnosis of prostate cancer * Favorable risk disease (cT1 or T2a, Gleason score (GS) 6, and Prostate Specific Antigen (PSA) \< 10 ng/mL) * Low-tier intermediate risk disease (cT2c,GS=6,and PSA 10-15 ng/mL, OR GS=7 and PSA \< 10 ng/mL) * Intermediate risk disease AND androgen deprivation therapy recommended by the treating physician for oncologic reasons such as (≥ 50% positive biopsy cores,cT2c,PSA 15-20 ng/mL,GS=7) * Patient requires baseline planning trans-rectal ultrasound for the purposes of prostate brachytherapy, showing prostate volume \> 40 mL and pubic arch interference (not required for those requiring androgen ablation for oncologic reasons) Exclusion Criteria: * castrate serum testosterone level * previous or concurrent pelvic radiotherapy * unable to give written informed consent * contraindications to permanent seed prostate brachytherapy or to androgen deprivation therapy * prior treatment for prostate cancer * prior trans-urethral resection of the prostate * previous therapy with a 5-α reductase inhibitor, anti-androgen agent, or LHRH agonist * previous therapy with degarelix

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