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The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer

Information source: Ferring Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: Degarelix (Drug); Degarelix (Drug); Leuprolide 7.5 mg (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Ferring Pharmaceuticals

Official(s) and/or principal investigator(s):
Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals

Summary

The study was a three-arm, active-control, multi-centre, parallel group study.

Clinical Details

Official title: An Open-label, Multi-Centre, Randomized, Parallel-group Study, Investigating the Efficacy and Safety of Degarelix One Month Dosing Regimens; 160 mg (40 mg/ml) and 80 mg (20mg/ml), in Comparison to LUPRON DEPOTŪ 7.5 mg in Patients With Prostate Cancer Requiring Androgen Ablation Therapy

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

Primary outcome: Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364

Secondary outcome:

Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment

Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3

Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252

Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28

Participants Grouped by Time to Prostate-specific Antigen Failure

Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)

The Mean Value of QTc Interval as Measured by Electrocardiogram

Participants With Markedly Abnormal Change in Vital Signs and Body Weight

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Main Inclusion Criteria:

- Patients, aged 18 years or over, with histologically proven prostate cancer of all

stages in whom endocrine treatment is indicated.

- Baseline testosterone >1. 5 ng/mL.

- Life expectancy of at least 12 months.

Locations and Contacts

Nemocnice Jindrichuv Hradec a.s., U Nemocnice 380/III, Jindrichuv Hradec 37738, Czech Republic

Urologische Klinik, Universitatsklinikum Mannheim, Theodor-Kutzer-Ufer 1-3, Mannheim 68167, Germany

Szeged M.J.V.O. Korhaza, Urologiai Osztaly, Kalvaria sugarut 57, Szeged H-6725, Hungary

Atrium MC, Henri Dunantstraat 5, Heerlen 6419 PC, Netherlands

Cristo Redentor Hospital, La Hacienda 00784, Puerto Rico

San Juan VA Medical Center, San Juan 00921, Puerto Rico

Provita Center, 2 Primaverii Street, Constanta 900635, Romania

Andros Urology Clinic, Ulitsa Lenina 36A, St Petersburg 197136, Russian Federation

Kiev City Clinical Hospital #3, Petr Ivaschenko 26, Petra Zaporogtsa str., Kiev 2125, Ukraine

Derriford Hospital, Derriford Road, Plymouth PL6 8DH, United Kingdom

Urology Centers of Alabama, Homewood, Alabama 35209, United States

Alaska Clinical Research Center, LLC, Anchorage, Alaska 99508, United States

Advanced Urology Medical Center, Anaheim, California 92801, United States

Pacific Clinical Center, Beverly Hills, California 90210, United States

Simi-San Faernando Valley Urology Associates, Granada Hills, California 91344, United States

South Orange County Medical Research Center, Laguna Woods,, California 92653, United States

Western Clinical Research, Torrance, California 90505, United States

University of Colorado, Denver, Colorado 80262, United States

Urology Associate PC, Denver, Colorado 80210, United States

Hospital General "Dr Santiago Ramon y Cajal", ISSSTE, Predio Canoas S/N, Durango, DGO 34079, Mexico

South Florida Medical Research, Aventura, Florida 33180, United States

Florida Foundation for Healthcare Research, Ocala, Florida 34474, United States

Regional Urology, Shreveport, Louisiana 71106, United States

Lawrenceville Urology, Lawrenceville, New Jersey 08648, United States

Jay A. Motola, MD, FACS, Carmel, New York 10512, United States

Northeast Urology Research, Concord, North Carolina 28025, United States

The Urology Center, Greensboro, North Carolina 27401, United States

Bruce W. Palmer Urology Inc, 125-70 Exhibition Street, Kentville, Nova Scotia B4N 4KB, Canada

State College Urologic Association, State College, Pennsylvania 16801, United States

Univeristy Urological Research Institute, Providence, Rhode Island 02904, United States

University Urological Research Institute, Providence, Rhode Island 02904, United States

Grand Strand Urology, Myrtle Beach, South Carolina 29572, United States

Urology San Antonio Research, San Antonio, Texas 78229, United States

Urology of Virginia Research, Norfolk, Virginia 23502, United States

Office of Jeffrey Frankel, Seattle, Washington 98166, United States

Additional Information

Starting date: February 2006
Last updated: December 17, 2012

Page last updated: August 23, 2015

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