Efficacy Study of Switching to a Lutenizing Hormone-releasing Hormone (LHRH) Antagonist From a LHRH Agonist to Treat Progressive Castrate Resistant Prostate Cancer (CRPC)
|ClinicalTrials.gov Identifier: NCT01630967|
Recruitment Status : Unknown
Verified June 2012 by Kim Chi, British Columbia Cancer Agency.
Recruitment status was: Not yet recruiting
First Posted : June 28, 2012
Last Update Posted : June 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Prostate Neoplasm||Drug: Degarelix||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Single Arm Study of Degarelix in Men With Castrate Resistant Prostate Cancer With a Rising Prostate-Specific Antigen (PSA) Despite LHRH Agonist Therapy.|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
Degarelix 240mg subcutaneously loading dose, then 80mg sc every month until disease progression.
Standard dosing and schedule for administration of degarelix will be used. 240mg s.c. loading dose, 80mg s.c. monthly maintenance dose.
Other Name: Firmagon
- 50% fall in PSA [ Time Frame: 8 weekly ]Proportion of patients with castrate resistant prostate cancer (CRPC) who have a PSA decline of ≥50% from baseline when switched from an LHRH agonist to an LHRH antagonist
- Luteinizing hormone (LH) [ Time Frame: 8 weekly ]Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
- Follicle stimulating hormone (FSH) [ Time Frame: 8 weekly ]Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
- Testosterone (TT) [ Time Frame: 8 weekly ]Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
- dehydroepiandrosterone (DHEA) [ Time Frame: 8 weekly ]
- dehydroepiandrosterone-sulfate (DHEA-S) [ Time Frame: 8 weekly ]
- androstenedione (AED) [ Time Frame: 8 weekly ]
- dihydrotestosterone (DHT) [ Time Frame: 8 weekly ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630967
|Contact: Kim N Chi, MD||+1 604 877 6000 ext firstname.lastname@example.org|
|Canada, British Columbia|
|British Columbia Cancer Agency|
|Vancouver, British Columbia, Canada, V5Z4E6|
|Principal Investigator:||Kim N Chi, MD||British Columbia Cancer Agency, Univeristy of British Columbia|