Feasibility and Toxicity of Degarelix for Prostate Downsizing Prior to Permanent Seed Prostate Brachytherapy - Full Text View

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:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Degarelix

U.S. FDA Resources

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.

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 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

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:	May 23, 2012
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 May 19, 2013