Degarelix Neo-Adjuvant Radical Prostatectomy Trial

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01674270
• Other study ID #: DEG_PRE-OP_001
• Secondary ID: Degarelix Pre-Op
• Status: Completed
• Phase: Phase 2
• First received: August 23, 2012
• Last updated: December 21, 2015
• Start date: August 2012
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix

• Casodex

• LHRH Agonist

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum levels of Androgen Receptor after neo-adjuvant therapy		Baseline, Week 12	No
Other	Serum level of Follicle Stimulating Hormone (FSH) after neo-adjuvant therapy		Baseline, Week 12	No
Other	Serum Level of Inhibin-b and GnRH after neo-adjuvant therapy		Baseline, Week 12	No
Primary	Intratumoral androgen levels		Week 12	No
Secondary	Prostate tumour morphology related to androgen withdrawal after neo-adjuvant therapy		Week 12	No