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Clinical Trial Details

Trial Information
 
Trial:  Prostate Cancer - Adjuvant treatment after prostatectomy for high risk patients
   
 
Principal Investigator:  Robert E. Reiter, MD
Co-Investigator(s):  Jean B. deKernion, MD; Arie Belldegrun, MD; Mark S. Litwin, MD, MPH; Allan Pantuck, MD, MS, FACS;
   
This trial is currently accepting new patient applications.  (Apply)


Objective
  A Multicenter, Open-Label, Randomized, Phase III Trial Comparing Immediate Adjuvant Hormonal Therapy (ELIGARD®- leuprolide acetate) in Combination with TAXOTERE® (docetaxel) Administered Every Three Weeks Versus Hormonal Therapy Alone Versus Deferred Therapy Followed by the Same Therapeutic Options in Patients with Prostate Cancer at High Risk of Relapse After Radical Prostatectomy (Amendment 1 dated 31 AUG 2005) UCLA  IRB #   05-11-090-01


Patient Eligibility
 

INCLUSION CRITERIA

  1. Pathologically confirmed adenocarcinoma of the prostate based on central pathology review. All other variants are excluded
  2. Randomization should occur less than 90 days after prostatectomy AND lymphadenectomy.
  3. A predicted probability of 5-year freedom from progression =60%, as determined by the postoperative nomogram developed by M. Kattan. This probability will be assessed using data from the prostatectomy specimen central review (Johns Hopkins, USA and Karolinska Institute, Sweden).

4. Bone-scan without evidence of metastasis (within 6 months of randomization)

5. Chest x-ray without evidence of metastasis (within 6 months of randomization)

6. Abdominal CT Scan without evidence of metastasis (within 6 months of randomization)


For More Information
  For additional information on inclusion and exclusion criteria and whether or not you may be a candidate to participate in a trial, call Nazy Zomorodian, Director for the Clinical Trials Office at (310) 825-5538.