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

Phase II Trial Assessing the Feasibility and Toxicity of Degarelix in Achieving Prostate Downsizing Prior to Treatment With Permanent Seed Prostate Brachytherapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01446991

Enrollment

Registered

2011-10-05

Start date

2012-04-30

Completion date

2017-12-31

Last updated

2020-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate neoplasm, brachytherapy, androgen ablation, benign prostatic hypertrophy, prostate size reduction, localized prostate cancer with prostate volume > 40 cc

Brief 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.

Detailed description

All men will have a baseline transrectal ultrasound for brachytherapy planning that has demonstrated an enlarged prostate with or without pubic arch obstruction. After signing the informed consent document they will have a loading dose of 240 mg Degarelix and then monthly maintenance dose injections of 80 mg until such time as sufficient prostate reduction has occured (2-3 months) or they complete the 6 months of required androgen ablation for their disease status.

Interventions

DRUGDegarelix

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

40 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
prostate volume reduction	3 months	determined by transrectal ultrasound with planimetry volume calculation

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026