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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Prostate Neoplasm

Intervention / Treatment
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* Drug: Degarelix


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Degarelix<br>Degarelix 240mg subcutaneously loading dose, then 80mg sc every month until disease progression. | Drug: Degarelix<br>* Standard dosing and schedule for administration of degarelix will be used. 240mg s.c. loading dose, 80mg s.c. monthly maintenance dose.<br>* Other names: Firmagon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 50% fall in PSA | 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 | 8 weekly | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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castrate resistance, PSA progression, LHRH antagonism