Degarelix Neo-Adjuvant Radical Prostatectomy Trial

Study Overview
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Brief Summary
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To assess the effect of neo-adjuvant GnRH antagonist, degarelix, versus LHRH agonist on intratumoral levels of androgens.

Official Title
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Phase II Randomized Open Label Study of Neo-Adjuvant Degarelix vs. LHRH Agonist in Prostate Cancer Patients Prior to Radical Prostatectomy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Degarelix
* Drug: Casodex
* Drug: LHRH Agonist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men >18 and =< 75 years of age Willing and able to provide informed consent, either alone or with the aid of a translator Histologically confirmed prostate cancer as determined by transrectal ultrasound (TRUS) guided prostate biopsy performed within 6 months of study enrolment Gleason Score >= 7and/or prostate cancer that is clinical stage T2 disease. Candidates for open radical prostatectomy considered surgically resectable by urologic evaluation Normal organ and marrow function as defined by the following criteria: Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 Exclusion Criteria: Previous or current use of hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, megestrol acetate, and ketoconazole) History of receiving radiation to the pelvic area. Previously received therapy with 5-alpha reductase inhibitors finasteride and/or dutasteride 4 weeks prior to randomization. History of bilateral orchiectomy, adrenalectomy, or hypophysectomy. History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema. Known hypersensitivity towards any component of the investigational medicinal product or Casodex (bicalutamide) or their excipients. Marked baseline prolongation of QT/QTcF interval (e.g. repeated demonstration of a QTcF interval >450 ms). History of risk factors for Torsade de Pointes ventricular arrhythmias (e.g. heart failure, hypokalemia, or family history of Long QT Syndrome). Previous history or presence of another malignancy, other than prostate cancer or treated squamous / basal cell carcinoma of the skin, within the last five years. Clinically significant laboratory abnormalities (e.g. severe renal or hepatic impairment) which in the judgment of the Investigator would affect the patient's health or the outcome of the trial. Clinically significant disorder (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient's health or the outcome of the trial as judged by the Investigator. Use of natural medicines thought to have endocrine effects on prostate cancer (e.g. saw palmetto and St. John's Wort) 4 weeks prior to randomization. Mental incapacity or language barrier precluding adequate understanding or co operation. Use of an investigational drug within the last 28 days preceding the Screening Visit or longer if considered to possibly influence the outcome of the current trial. Previously participated in any degarelix trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Degarelix<br>Degarelix Alone | Drug: Degarelix<br> <br> |
| Experimental: Degarelix + Casodex<br>Degarelix and Casodex | Drug: Degarelix<br> <br> Drug: Casodex<br> <br> |
| Active Comparator: LHRH Agonist + Casodex<br>LHRH Agonist and Casodex | Drug: Casodex<br> <br> Drug: LHRH Agonist<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intratumoral androgen levels |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate tumour morphology related to androgen withdrawal after neo-adjuvant therapy |  | Week 12 |