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.
|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|
- prostate volume reduction [ Time Frame: 3 months ] [ Designated as safety issue: No ]determined by transrectal ultrasound with planimetry volume calculation
- 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.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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.
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 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.
240 mg loading dose of Degarelix followed by 80 mg maintenance doses every month for a total duration of 6 months.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446991
|Contact: Juanita M Crook, MD||250 712 email@example.com|
|Contact: Ross Halperin, MD||250 712 firstname.lastname@example.org|
|Canada, British Columbia|
|Abbottsford Cancer Center||Not yet recruiting|
|Abbottsford, British Columbia, Canada|
|Contact: Howard Pai, MD 604 851 4710 email@example.com|
|Principal Investigator: Howard Pai, MD|
|Fraser Valley Cancer Center||Not yet recruiting|
|Surrey, British Columbia, Canada|
|Contact: Stacy Miller, MD 604 930 2098 firstname.lastname@example.org|
|Principal Investigator: Stacy Miller, MD|
|Vancouver Cancer Center||Recruiting|
|Vancouver, British Columbia, Canada, V5Z4E6|
|Contact: Mira Keyes, MD email@example.com|
|Principal Investigator: Mira Keyes, MD|
|Principal Investigator:||Juanita M Crook, MD||British Columbia Cancer Agency|