An Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

An Open-Label, Multi-Centre, Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Patients With Prostate Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00215683
• Other study ID #: FE200486 CS12A
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 20, 2005
• Last updated: March 12, 2015
• Start date: February 2005
• Est. completion date: November 2009

Study information

• Verified date: March 2015
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPRussia: Ethics CommitteeRussia: FSI Scientific Center of Expertise of Medical ApplicationRussia: Ministry of Health of the Russian FederationRomania: Ministry of Public HealthRomania: National Authority for Scientific ResearchRomania: National Medicines AgencyRomania: State Institute for Drug ControlNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Germany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesSouth Africa: Department of HealthSouth Africa: Human Research Ethics CommitteeSouth Africa: Medicines Control CouncilSouth Africa: National Health Research Ethics CouncilHungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial Summary

This was an extension study for the study FE200486 CS12 (NCT00819156). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.

The study was terminated when all ongoing participants had been treated for at least 5 years (including one year in the main study).

Description:

Participants who completed the main FE200486 CS12 study initially continued with the same dose in the FE200486 CS12A extension study. After a protocol amendment all study participants were treated with 160 mg (40 mg/mL).

The data include data from the participants who participated in both the main study (FE200486 CS12; NCT00819156) and the extension study FE200486 CS12A.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: November 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Had given written consent before any study-related activity was performed (a study-related activity was defined as any procedure that would not have been performed during the normal management of the participant)

• Had completed the FE200486 CS12 study

Exclusion criterion:

• Had been withdrawn from the FE200486 CS12 study

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix
Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 28 days until the end of the study.

Locations

Country	Name	City	State
Belgium	UCL Saint Luc	Bruxelles
Belgium	UZ Gent	Gent
Belgium	UZ Gasthuisberg, Urology Department	Leuven
Germany	Vivantes Klinikum am Urban, Klinik für Urologie	Berlin
Germany	Urologische Universitätsklinikum, Klinikum Mannheim GmbH, Fakultät für Klinische Medizin Mannheim	Mannheim
Hungary	Bajcsy-Zsilinszky Hospital, of local Government of Budapest, Dept. of Urology	Budapest
Hungary	Jahn Ferenc Dél-Pesti Hospital, Dept. of Urology	Budapest
Hungary	Pez Aladar County Hospital, Dept. of Urology	Györ
Hungary	Bács-Kiskun County Hospital, Dept. of Urology	Kecskemét
Hungary	BAZ County Hospital, Dept of Urology	Miskolc
Hungary	Hospital of Local Government of Szeged, Dept. of Urology	Szeged
Hungary	MÁV Hospital, Dept. of Urology	Szolnok
Netherlands	Academic Medical Center, Dept. of Urology	Amsterdam
Netherlands	Atrium MC, Dept. of Urology	Heerlen
Romania	"Prof.Dr.Th.Burghele" Hospital - Bucharest	Bucharest
Romania	"Sf. Ioan" Emergency Hospital - Urology Department	Bucharest
Romania	CF2 Hospital - Bucharest, Urology Department	Bucharest
Romania	Fundeni Clinical Institute - Bucharest, Urology Department	Bucharest
Russian Federation	Moscow State University of Medicine and Dentistry, Department of Urology, Urogynecology and Andrology, City Hospital #50, Urology Department	Moscow
Russian Federation	Russian Medical Academy of Postgraduate Education, Department of Gerontolology and Geriatrics, Moscow City Hospital #60, Urology Department, 84/1, Entuziastov Shosse (Hospital)	Moscow
Russian Federation	Russian Medical Academy of Postgraduate Education, Urology Department, Moscow Clinical Hospital n.a. Botkin, Urology Department, 5/16, 2-oy Botkinsky proezd (Hospital)	Moscow
Russian Federation	Russian State Medical University, Department of Urology and Surgical Nephrology, Moscow City Hospital #1	Moscow
Russian Federation	City Hospital #15, Urology Department	St Petersburg
Russian Federation	City Hospital #26, Urology Department	St Petersburg
Russian Federation	I.I. Mechnikov St. Petersburg State Medical Academy, Urology Department	St Petersburg
Russian Federation	Research Institute of Urology of the Ministry of Healthcare of the Russian Federation	St Petersburg
Russian Federation	St. Petersburg Pavlov Medical School, Urology Department	St Petersburg
Russian Federation	St.Petersburg Pavlov Medical School, Outpatient Diagnostic Center	St Petersburg
Russian Federation	"Andros" Urology Clinic, 36A, Lenina St.	St. Petersburg
South Africa	Glenwood Hospital	Durban
South Africa	WITS Medical School, Level 9	Parktown
South Africa	401 B Medical Centre	Pietermaritzburg
South Africa	Pretoria Urology Hospital, Suite 2, Hatfield	Pretoria
South Africa	Sunninghill Clinic, Suite 3	Sunninghill

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  Germany,  Hungary,  Netherlands,  Romania,  Russian Federation,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants With Markedly Abnormal Change in Vital Signs and Body Weight	Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.	5 years	No
Primary	Liver Function Tests	The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.	5 years	No