Clinical trial NCT00295750: The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer
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 DEPOT® 7.5 mg in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-02-24
Enrollment: 620
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment
timeFrame: 2 weeks
measure: Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3
timeFrame: 3 days
measure: Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252
timeFrame: Day 252, Day 255, and Day 259
measure: Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28
timeFrame: Days 14 and 28
measure: Participants Grouped by Time to Prostate-specific Antigen Failure
timeFrame: 12 months
measure: Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)
timeFrame: Baseline to Day 364
measure: The Mean Value of QTc Interval as Measured by Electrocardiogram
timeFrame: 12 months
measure: Participants With Markedly Abnormal Change in Vital Signs and Body Weight
timeFrame: 12 months
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama
state: Alabama
city: Anchorage
country: United States
facility: Alaska Clinical Research Center, LLC
state: Alaska
city: Anaheim
country: United States
facility: Advanced Urology Medical Center
state: California
city: Beverly Hills
country: United States
facility: Pacific Clinical Center
state: California
city: Granada Hills
country: United States
facility: Simi-San Faernando Valley Urology Associates
state: California
city: Laguna Woods,
country: United States
facility: South Orange County Medical Research Center
state: California
city: Torrance
country: United States
facility: Western Clinical Research
state: California
city: Denver
country: United States
facility: Urology Associate PC
state: Colorado
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Ocala
country: United States
facility: Florida Foundation for Healthcare Research
state: Florida
city: Shreveport
country: United States
facility: Regional Urology
state: Louisiana
city: Lawrenceville
country: United States
facility: Lawrenceville Urology
state: New Jersey
city: Carmel
country: United States
facility: Jay A. Motola, MD, FACS
state: New York
city: Concord
country: United States
facility: Northeast Urology Research
state: North Carolina
city: Greensboro
country: United States
facility: The Urology Center
state: North Carolina
city: State College
country: United States
facility: State College Urologic Association
state: Pennsylvania
city: Providence
country: United States
facility: Univeristy Urological Research Institute
state: Rhode Island
city: Providence
country: United States
facility: University Urological Research Institute
state: Rhode Island
city: Myrtle Beach
country: United States
facility: Grand Strand Urology
state: South Carolina
city: San Antonio
country: United States
facility: Urology San Antonio Research
state: Texas
city: Norfolk
country: United States
facility: Urology of Virginia Research
state: Virginia
city: Seattle
country: United States
facility: Office of Jeffrey Frankel
state: Washington
city: Kentville
country: Canada
facility: Bruce W. Palmer Urology Inc, 125-70 Exhibition Street
state: Nova Scotia
city: Jindrichuv Hradec
country: Czech Republic
facility: Nemocnice Jindrichuv Hradec a.s., U Nemocnice 380/III
city: Mannheim
country: Germany
facility: Urologische Klinik, Universitatsklinikum Mannheim, Theodor-Kutzer-Ufer 1-3
city: Szeged
country: Hungary
facility: Szeged M.J.V.O. Korhaza, Urologiai Osztaly, Kalvaria sugarut 57
city: Predio Canoas S/N
country: Mexico
facility: Hospital General "Dr Santiago Ramon y Cajal", ISSSTE
state: Durango, DGO
city: Heerlen
country: Netherlands
facility: Atrium MC, Henri Dunantstraat 5
city: La Hacienda
country: Puerto Rico
facility: Cristo Redentor Hospital
city: San Juan
country: Puerto Rico
facility: San Juan VA Medical Center
city: Constanta
country: Romania
facility: Provita Center, 2 Primaverii Street
city: St Petersburg
country: Russian Federation
facility: Andros Urology Clinic, Ulitsa Lenina 36A
city: Kiev
country: Ukraine
facility: Kiev City Clinical Hospital #3, Petr Ivaschenko 26, Petra Zaporogtsa str.
city: Plymouth
country: United Kingdom
facility: Derriford Hospital, Derriford Road
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
citation: Klotz L, Boccon-Gibod L, Shore ND, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK, Schroder FH. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008 Dec;102(11):1531-8. doi: 10.1111/j.1464-410X.2008.08183.x.
citation: Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.