Androgen Deprivation Therapy in Treating Patients With Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00110162|
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : May 4, 2005
Last Update Posted : August 7, 2013
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens.
PURPOSE: This randomized phase III trial is studying how well androgen deprivation therapy works in treating patients with prostate cancer.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: antiandrogen therapy Drug: releasing hormone agonist therapy Procedure: orchiectomy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Official Title:||A Collaborative Randomized Phase III Trial: The Timing of Intervention With Androgen Deprivation in Prostate Cancer Patients With Rising PSA|
|Study Start Date :||October 2004|
|Estimated Primary Completion Date :||December 2009|
- Death from any cause at 8 years
- Cancer specific survival
- Clinical progression
- Time to first androgen independence
- Complication rate incidence and timing (e.g., cord compression, pathological fracture)
- Treatment-related morbidity (including cognitive, osteoporosis)
- Prognostic factors for progression (delayed group)
- EORTC Quality of life - general QLQC30 and prostate module for Quality of life annually for 5 years
- CTC v3.0 Survival endpoints: actuarial analysis at eight years
- Morbidity continuously
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00110162
|Study Chair:||Gillian M. Duchesne, MD, FRCR||Peter MacCallum Cancer Centre, Australia|