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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by British Columbia Cancer Agency
Sponsor:
Information provided by (Responsible Party):
Juanita Crook, British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT01446991
First received: October 4, 2011
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Degarelix
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial Assessing the Feasibility and Toxicity of Degarelix in Achieving Prostate Downsizing Prior to Treatment With Permanent Seed Prostate Brachytherapy

Resource links provided by NLM:


Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • prostate volume reduction [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    determined by transrectal ultrasound with planimetry volume calculation


Secondary Outcome Measures:
  • testosterone recovery [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Luteinizing Hormone(LH), Follicle Stimulating Hormone (FSH) and testosterone will be measured at 1, 3, 6, 9 and 12 months following cessation of Degarelix.


Estimated Enrollment: 50
Study Start Date: April 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Degarelix
240 mg loading dose followed by monthly 80 mg maintenance dose for 2-3 months
Experimental: Intermediate risk prostate cancer, 6 months Degarelix
Men in this arm have higher risk prostate cancer (upper tier intermediate risk by 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.
Drug: Degarelix
240 mg loading dose of Degarelix followed by 80 mg maintenance doses every month for a total duration of 6 months.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446991

Contacts
Contact: Juanita M Crook, MD 250 712 3979 jcrook@bccancer.bc.ca
Contact: Ross Halperin, MD 250 712 3900 rhalperin@bccancer.bc.ca

Locations
Canada, British Columbia
Abbottsford Cancer Center Not yet recruiting
Abbottsford, British Columbia, Canada
Contact: Howard Pai, MD    604 851 4710    hpai@bccancer.bc.ca   
Principal Investigator: Howard Pai, MD         
Fraser Valley Cancer Center Not yet recruiting
Surrey, British Columbia, Canada
Contact: Stacy Miller, MD    604 930 2098    smiller@bccancer.bc.ca   
Principal Investigator: Stacy Miller, MD         
Vancouver Cancer Center Recruiting
Vancouver, British Columbia, Canada, V5Z4E6
Contact: Mira Keyes, MD       mkeyes@bccancer.bc.ca   
Principal Investigator: Mira Keyes, MD         
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
Principal Investigator: Juanita M Crook, MD British Columbia Cancer Agency
  More Information

No publications provided

Responsible Party: Juanita Crook, MD FRCPC Radiation Oncology, British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT01446991     History of Changes
Other Study ID Numbers: H11-08172
Study First Received: October 4, 2011
Last Updated: July 26, 2013
Health Authority: Canada: Institutional Review Board

Keywords provided by British Columbia Cancer Agency:
prostate neoplasm
brachytherapy
androgen ablation
benign prostatic hypertrophy
prostate size reduction
localized prostate cancer with prostate volume > 40 cc

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 29, 2014