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.
Overview
- Phase
- Phase 2
- Intervention
- Degarelix
- Conditions
- Prostate Neoplasm
- Sponsor
- British Columbia Cancer Agency
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 50% fall in PSA
- Last Updated
- 13 years ago
Overview
Brief Summary
Men with castrate resistant prostate cancer who are switched from a luteinizing hormone-releasing hormone (LHRH) antagonists from a LHRH agonist will experience a fall in prostate-specific antigen (PSA).
Detailed Description
To determine the proportion of patients with castrate resistant Prostate Cancer who have a PSA decline of ≥50% from baseline PSA when switched from an LHRH agonist to an LHRH antagonist.
Investigators
Kim Chi
Associate Professor of Medicine, University of British Columbia
British Columbia Cancer Agency
Eligibility Criteria
Inclusion Criteria
- •histologically confirmed adenocarcinoma of the prostate
- •currently receiving LHRH agonist
- •Anti-androgen oral therapy is permitted but will be discontinued upon enrollment
- •PSA \> 2 ng/ml
- •rising PSA despite LHRH agonist
- •patients may or may not have clinical evidence off metastases. If metastases are present, they must be asymptomatic and in bone or lymph node only
- •Prior chemotherapy allowed
- •ECOG performance status 0-1
Exclusion Criteria
- •Patients with a history of other active malignancies, except: adequately treated non-melanoma skin cancer, superficial bladder cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 3 years.
- •Other serious illness, psychiatric or medical condition that would not permit the patient to be managed according to the protocol including: i)Significant cardiovascular condition including but not limited to: uncontrolled hypertension, unstable angina, significant congestive heart failure or myocardial infarction, deep venous thrombosis, pulmonary embolus or cerebrovascular attack within the last 6 months. ii) History of significant neurological disorder that would impair the ability to obtain consent
Arms & Interventions
Degarelix
Degarelix 240mg subcutaneously loading dose, then 80mg sc every month until disease progression.
Intervention: Degarelix
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Luteinizing hormone (LH)(8 weekly)
- Follicle stimulating hormone (FSH)(8 weekly)
- Testosterone (TT)(8 weekly)
- dehydroepiandrosterone (DHEA)(8 weekly)
- dehydroepiandrosterone-sulfate (DHEA-S)(8 weekly)
- androstenedione (AED)(8 weekly)
- dihydrotestosterone (DHT)(8 weekly)