Overview

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