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Degarelix Neo-Adjuvant Radical Prostatectomy Trial | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Degarelix Neo-Adjuvant Radical Prostatectomy Trial

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

NCT01674270•University Health Network, Toronto

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 75 years

Sex

MALE

Healthy Volunteers

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.
+5 more criteria

Locations (2)

Vancouver General Hospital

Vancouver, British Columbia, Canada

University Health Network

Toronto, Ontario, Canada

Key Dates

Start Date

August 1, 2012

Primary Completion Date

December 1, 2014

Completion Date

November 1, 2015

Last Updated

December 22, 2015

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

Degarelix

DRUG

Casodex

DRUG

LHRH Agonist

DRUG

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

NCT05691465

Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationMetastatic Prostate Neuroendocrine Carcinoma+2 more

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RECRUITINGPHASE2

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Degarelix Neo-Adjuvant Radical Prostatectomy Trial

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC