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

British Columbia Cancer Agency

Status and phase: Unknown; Phase 2

Conditions: Prostate Neoplasm

Treatments: Drug: Degarelix

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01630967

BCCA_Deg01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Degarelix

Experimental group

Description:

Degarelix 240mg subcutaneously loading dose, then 80mg sc every month until disease progression.

Treatment:

Drug: Degarelix