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Completed

NCT Number: NCT01446991

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

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.

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Key information

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Abbottsford Cancer Center, Abbottsford, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

degarelix

Drug

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

Primary outcomes

  1. prostate volume reduction

    Time frame: 3 months

    determined by transrectal ultrasound with planimetry volume calculation

Secondary outcomes

  1. testosterone recovery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

British Columbia Cancer Agency

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Oct 5, 2011
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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