To compare prostate-specific antigen (PSA) progression-free survival (PFS) failure rates during long-term treatment with 3-monthly subcutaneous (s.c.) injections of degarelix or goserelin in prostate cancer patients (PSA PFS failure is defined as…
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint
* Hazard ration of PSA PFS failure rates during 3 years treatment between
degarelix and goserlin.
Secondary outcome
Secondary endpoints
* Hazard ratio of PFS failure rates during 3 years' treatment between degarelix
and goserelin
* Hazard ratio of PSA failure rates during 3 years' treatment between degarelix
and goserelin
* Hazard ratio of the rates of introduction of additional therapy related to
prostate cancer during 3 years' treatment between degarelix and goserelin
* Hazard ratio of mortality rates during 3 years' treatment between degarelix
and goserelin
* Serum levels of testosterone and PSA over time.
* Hazard ratio of testosterone escape rates during 3 years' treatment between
degarelix and goserlin
* Frequency and severity of adverse events
* Changes in alkaline phosphatase over time
* Clinically significant changes in laboratory safety parameters
* Clinically significant changes in physical examinations, ECG's, vital signs
and body weight.
Background summary
Prostate cancer is the most frequent cancer diagnosed in men. Degarelix is a
gonadotrophin releasing hormone receptor blocker (GnRH) and is highly selective
in binding to the GnRH receptor resulting in the suppression of pituitary
gonadotrophins, leading to testosterone suppression.
This is an open-label trial extending the CS35 trial. The patients will
continue to receive the same 3-monthly treatment as they received in the CS35
for 2 additional years after entering the extension phase.
Study objective
To compare prostate-specific antigen (PSA) progression-free survival (PFS)
failure rates during long-term treatment with 3-monthly subcutaneous (s.c.)
injections of degarelix or goserelin in prostate cancer patients (PSA PFS
failure is defined as either PSA failure or death, whichever is first).
Study design
Open-label, multi-center, extension study
Intervention
Degarelix powder and solvent for suspension for s.c. injection: three-month
dose of 480 mg degarelix.
Goserlin acetate (Zoladex) implant: three-month implant of 10,8 mg s.c.
Study burden and risks
Procedures during 2 years of study participation:
3 x weight & length
2 x physical examination
3 x ECG
5 x urine analysis
10 x blood sampling
10 x vital signs
Kay Fiskers Plads 11
DK-2300 Copenhagen
Denmark
Kay Fiskers Plads 11
DK-2300 Copenhagen
Denmark
Listed location countries
Age
Inclusion criteria
Patients who complete the main trial (CS35) after the initiation of CS35A will be eligible for inclusion in the CS35A extension trial. Signed informed consent will be obtained before any trial-related activity is performed.
Exclusion criteria
Patients who complete the main trial (CS35) after the initiation of CS35A will be eligible for inclusion in the CS35A extension trial. Signed informed consent will be obtained before any trial-related activity is performed.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-021434-55-NL |
| CCMO | NL34265.060.10 |