Triptorelin and Radiation Therapy in Treating Patients Who Have Undergone Surgery for Intermediate-Risk Stage III or Stage IV Prostate Cancer
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00667069 |
Recruitment Status :
Active, not recruiting
First Posted : April 25, 2008
Last Update Posted : April 14, 2023
|
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | April 24, 2008 | ||||
First Posted Date ICMJE | April 25, 2008 | ||||
Last Update Posted Date | April 14, 2023 | ||||
Actual Study Start Date ICMJE | April 7, 2008 | ||||
Actual Primary Completion Date | April 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Event-free survival [ Time Frame: From randomization to disease progression or death, up to 5 years ] The event-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse (clinical progression, biochemical progression, death)
|
||||
Original Primary Outcome Measures ICMJE |
Event-free survival (clinical progression, biochemical progression, death) at 5 years | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE |
|
||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Triptorelin and Radiation Therapy in Treating Patients Who Have Undergone Surgery for Intermediate-Risk Stage III or Stage IV Prostate Cancer | ||||
Official Title ICMJE | Randomized, Multicenter Study Comparing the Immediate Adjuvant Radiotherapy Associate With Hormonal Therapy of LH-RH Analogue (Decapeptyl® LP) vs Delayed Radiotherapy Until Biochemical Relapse Associated With Hormonal Therapy of LH-RH Analogue (Decapeptyl® LP) in Patients With Operable Prostate Cancer pT3 R1 pN0 or pNx at Intermediate Risk. | ||||
Brief Summary | RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as triptorelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving triptorelin and radiation therapy soon after surgery or later after surgery is more effective in treating prostate cancer. PURPOSE: This randomized phase III trial is studying giving triptorelin and radiation therapy soon after surgery to see how well it works compared with giving them later after surgery in treating patients who have undergone surgery for intermediate-risk stage III or stage IV prostate cancer. |
||||
Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed for up to 5 years. |
||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
Condition ICMJE | Prostate Cancer | ||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
Publications * |
|
||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
424 | ||||
Original Enrollment ICMJE |
718 | ||||
Estimated Study Completion Date ICMJE | April 2025 | ||||
Actual Primary Completion Date | April 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00667069 | ||||
Other Study ID Numbers ICMJE | GETUG-AFU 17 - UC-0160/0702 2007-002495-34 ( EudraCT Number ) CDR0000577485 ( Other Identifier: Unicancer ) |
||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE |
|
||||
Current Responsible Party | UNICANCER | ||||
Original Responsible Party | Not Provided | ||||
Current Study Sponsor ICMJE | UNICANCER | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Ipsen | ||||
Investigators ICMJE |
|
||||
PRS Account | UNICANCER | ||||
Verification Date | April 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |