Efficacy Study of Switching to a Lutenizing Hormone-releasing Hormone (LHRH) Antagonist From a LHRH Agonist to Treat Progressive Castrate Resistant Prostate Cancer (CRPC)

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: British Columbia Cancer Agency
• Collaborator: Ferring Pharmaceuticals

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