Feasibility and Toxicity of Degarelix for Prostate Downsizing Prior to Permanent Seed Prostate Brachytherapy
|ClinicalTrials.gov Identifier: NCT01446991|
Recruitment Status : Active, not recruiting
First Posted : October 5, 2011
Last Update Posted : August 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Degarelix||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial Assessing the Feasibility and Toxicity of Degarelix in Achieving Prostate Downsizing Prior to Treatment With Permanent Seed Prostate Brachytherapy|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||February 2017|
|Estimated Study Completion Date :||December 2017|
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.
- prostate volume reduction [ Time Frame: 3 months ]determined by transrectal ultrasound with planimetry volume calculation
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446991
|Canada, British Columbia|
|Abbottsford Cancer Center|
|Abbottsford, British Columbia, Canada|
|Fraser Valley Cancer Center|
|Surrey, British Columbia, Canada|
|Vancouver Cancer Center|
|Vancouver, British Columbia, Canada, V5Z4E6|
|Principal Investigator:||Juanita M Crook, MD||British Columbia Cancer Agency|