A Phase II Study of Degarelix in the Management of Non-Metastatic Hormone-Refractory Prostate Cancer

Study Overview
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Brief Summary
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This study is being offered to patients who have hormone resistant prostate cancer (HRPC). This means that their prostate cancer is no longer responding to standard hormonal therapy. The purpose of this study is to determine whether Degarelix will be able to stop the PSA from rising in patients with hormone resistant prostate cancer.

Detailed Description
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This is a phase II study of a GnRH antagonist drug, Degarelix, for use in hormone resistant prostate cancer patients who have had biochemical PSA progression despite the use of total androgen blockade therapy. Patients will receive at least six monthly injections of Degarelix unless the patient shows radiographic or symptomatic disease progression, intolerable toxicity or decides to withdraw from the study. Patients will be evaluated for measures of efficacy, toxicity and disease progression during treatment and afterwards until radiologically confirmed metastatic disease progression or until the patient is removed from the study. Overall objective: The efficacy of Degarelix as a treatment for HRPC will be evaluated

Official Title
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A Phase II Study of Degarelix in the Management of Non-Metastatic Hormone-Refractory Prostate Cancer

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Drug: Degarelix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prior trial of total androgen blockade Confirmed biochemical PSA progression on agonist therapy, defined as ≥ 50% increase in PSA between 2 measurements, taken at least 1 week apart. In patients that are currently on total androgen blockade (LHRH agonist plus non-steroidal anti-androgen) there must be a trial withdrawal of androgen receptor antagonists to ensure that there is no PSA response (6 weeks for bicalutamide and 4 weeks for flutamide or nilutamide). Radiologically confirmed non-metastatic disease within 90 days of registration based on negative chest radiographs, CT Scan Abdomen/Pelvis and Bone scan ECOG ≤ 2 Age ≥ 18 years Serum testosterone of ≤ 50 mg/dl PSA ≥ 2.0 ng/ml White blood cell count ≥ 3000/mm3 Platelets ≥ 100,000/mm3 Serum creatinine ≤ 1.5 x upper limits of normal Bilirubin ≤ 1.5 x upper limits of normal Alanine transaminase ≤ 1.25 x upper limits of normal Estimated life expectancy of at least 12 months Able and willing to sign informed consent Exclusion Criteria: Prior treatment with chemotherapy, radiopharmaceuticals, estrogen, PC-SPES, ketoconazole or other second line hormonal therapy (other than non-steroidal anti-androgens or Androcur) Known allergy to GnRH agonists or antagonists Previous treatment with Degarelix Major surgery within 4 weeks of registration Grade ≥ 3 peripheral neuropathy Severe, active co-morbidity such as unstable angina, congestive heart failure or myocardial infarction within the last 6 months or congenital long QT syndrome Acute deep vein thrombosis or pulmonary embolism Taking anti-arrhythmia medication Second malignancy other than non-melanoma skin cancer unless disease free ≥ 5 years. Prior orchiectomy for prostate cancer PSA > 100 ng/mL

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 treatment will consist of a starting dose of 240mg injected subcutaneously (s.c) and monthly s.c. maintenance doses of 80mg for a total duration of 6 months. | Drug: Degarelix<br>* Treatment will consist of a starting dose of 240mg injected subcutaneously (s.c) and monthly s.c. maintenance doses of 80mg for a total duration of 6 months.<br>* Other names: Firmagon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA Progression | Blood work will be done once a month during the 6 months of treatment then every 3 months until disease progression or participant withdrawal | Monthly for 6 months then every 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Disease progression | Blood work will be done once a month during the 6 months of treatment then every 3 months until disease progression or participant withdrawal | Monthly for 6 months then every 3 months | 
| The efficacy of Testosterone, LH and FSH suppression with Degarelix | Blood work will be done once a month during the 6 months of treatment then every 3 months until disease progression or participant withdrawal | Monthly for 6 months then every 3 months | 
| The impact of monthly injections of Degarelix on Health Related Quality of Life Issues in patients with prostate cancer | The EPIC-26 Expanded Prostate Cancer Index Composite is used to measure quality of life issues in patients with prostate cancer. The questionnaire will be done months 3 and 6 then every 3 months | Month 3 and 6 then every 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anti-androgens, prostate, hormone-resistant, degarelix, firmagon, total androgen blockade, injection