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A Comparative Study of Degarelix Three-month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Comparative Study of Degarelix Three-month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer

An Open-label Multi-center, Randomized Parallel Group Comparison of Efficacy and Safety of Degarelix Three-Month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer

NCT00116753•Ferring Pharmaceuticals

View on ClinicalTrials.gov

Summary

The rationale of the study was to evaluate different degarelix dosing regimens for a three-month interval that was to produce and maintain castration in prostate cancer patients through immediate and prolonged testosterone suppression, and to provide confirmatory evidence of the safety of degarelix.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Has given written consent before any study-related activity is performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient.
•Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages) in whom endocrine treatment, except for neoadjuvant hormonal therapy, is indicated. This includes patients with rising PSA after having undergone prostatectomy or radiotherapy with curative intention.
•Is a male patient aged 18 years or over.
•Has a baseline serum testosterone level above the lower limit of normal range, globally defined as \>2.2 ng/mL.
•Has an ECOG (Eastern Cooperative Oncology Group) score of 2.
•Has a PSA value of 2 ng/mL.
•Has a life expectancy of at least 13 months.

Exclusion Criteria

•Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, oestrogens). However, patients having undergone prostatectomy or radiotherapy with curative intention, neoadjuvant hormonal therapy is accepted for a maximal duration of 6 months. This treatment should have been terminated at least 6 months prior to the Screening Visit.
•Is considered to be a candidate for curative therapy, i.e. radical prostatectomy or radiotherapy within 13 months from Screening Visit.
•Has a history of, or predisposition to, severe hypersensitivity reactions such as severe asthma (defined as a need for daily treatment with inhalation steroids to control the asthma), anaphylactic reactions, or chronic or recurrent urticaria and/or angioedema.
•Has hypersensitivity towards any component of the investigational medicinal product. 5. Has had a cancer disease within the last five years except for prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.
•Has a known or suspected hepatic or symptomatic biliary disease.
•Has elevated serum ALT level above upper level of normal range or serum total bilirubin level above upper level of normal range as measured by the laboratory at the Screening Visit.
•Has other clinically significant laboratory abnormalities, which in the judgment of the investigator would interfere with the patient's participation in this study or evaluation of study results.
•Has a clinically significant disorder (other than prostate cancer) or any other condition, including excessive alcohol or drug abuse, which may interfere with study participation or which may affect the conclusion of the study as judged by the investigator.
•Has a mental incapacity or language barriers precluding adequate understanding or cooperation.
•Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered by the investigator to possibly influence the outcome of the current study.
+1 more criteria

Locations (56)

Urology Centers of Alabama

Homewood, Alabama, United States

Medical Affiliationed Research Center

Huntsville, Alabama, United States

Alaska Clinical Research Center, LLC

Anchorage, Alaska, United States

Advanced Urology Medical Center

Anaheim, California, United States

Center for Urological Research

La Mesa, California, United States

South Orange County Medical Research Center

Laguna Woods, California, United States

West Coast Clinical Research

Tarzana, California, United States

Western Clinical Research

Torrance, California, United States

Urology Research Option

Aurora, Colorado, United States

South Florida Medical Research

Aventura, Florida, United States

Key Dates

Start Date

January 1, 2005

Primary Completion Date

November 1, 2006

Completion Date

November 1, 2006

Last Updated

December 10, 2010

Enrollment

460

ACTUAL participants

Conditions

Prostate Cancer

Interventions

Degarelix

DRUG

Degarelix

DRUG

Degarelix

DRUG

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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 10, 2010Data 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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A Comparative Study of Degarelix Three-month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer

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

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

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

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

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