degarelix
Drug240 mg loading dose followed by monthly 80 mg maintenance dose for 2-3 months
NCT Number: NCT01446991
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.
Looking for future studies?
Notify Me40 year–80 year
Male
Interventional
Phase 2
Abbottsford Cancer Center, Abbottsford, British Columbia, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
240 mg loading dose followed by monthly 80 mg maintenance dose for 2-3 months
Time frame: 3 months
determined by transrectal ultrasound with planimetry volume calculation
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.
British Columbia Cancer Agency
Other
Phase II Trial Assessing the Feasibility and Toxicity of Degarelix in Achieving Prostate Downsizing Prior to Treatment With Permanent Seed Prostate Brachytherapy
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.
Published trials that share one or more normalized conditions with this study.
NCT06589154
Benign Prostatic Hyperplasia, Genital Diseases
Beijing, Beijing Municipality, China
View Trial DetailsNCT05803096
Anxiety Disorders, Anxiety and Fear
Boston, Massachusetts, United States
View Trial DetailsNCT05506735
Genital Diseases, Genital Diseases, Male
Nasiriyah, Thi Qar, Iraq
View Trial DetailsNCT04446429
Alopecia, Androgenetic Alopecia
Brasília, Brazil
View Trial Details