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

Phase 2

• Conditions: Prostate Neoplasm
• Interventions: Drug: Degarelix

• Registration Number: NCT01630967
• Lead Sponsor: British Columbia Cancer Agency

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.

Study Timeline

• Status Verified: 2012-06
• Study First Submitted: 2012-06-25
• Study First Submitted QC: 2012-06-27
• Last Update Submitted: 2012-06-27
• Study First Posted: 2012-06-28
• Last Update Posted: 2012-06-28
• Study Start: 2012-08
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
50% fall in PSA	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 Outcome Measures

Name	Time	Method
Luteinizing hormone (LH)	8 weekly	Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
Follicle stimulating hormone (FSH)	8 weekly	Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
Testosterone (TT)	8 weekly	Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
dehydroepiandrosterone (DHEA)	8 weekly	Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
dehydroepiandrosterone-sulfate (DHEA-S)	8 weekly	Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
androstenedione (AED)	8 weekly	Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
dihydrotestosterone (DHT)	8 weekly	Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

Trial Locations

Locations (1)

British Columbia Cancer Agency; 🇨🇦 Vancouver, British Columbia, Canada