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Prostate Cancer

Radiation with Androgen Deprivation (7048)
Phase 2 Trial of Radiation with Androgen Deprivation (RAD): Abiraterone Acetate, Prednisone and LHRH Agonist Prior to and Concurrent with Radiation Therapy.
Status Conditions Phase Study ID
Recruiting Prostate Cancer
Adenocarcinoma of the Prostate
Stage II Prostate Cancer
Stage III Prostate Cancer
Stage IV Prostate Cancer		 Phase II 7048
NCT01023061
Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as abiraterone acetate (Zytiga), leuprolide acetate, and goserelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving abiraterone acetate and leuprolide acetate or goserelin before or together with radiation therapy may be an effective treatment for prostate cancer.

PURPOSE: This phase II trial is studying the side effects and how well giving abiraterone acetate, prednisone, and leuprolide acetate or goserelin before and during radiation therapy works in treating patients with localized or locally advanced prostate cancer.


Investigator
Robert Montgomery, MD Kenneth J. Russell
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion

  • Willing and able to provide written informed consent
  • Patients must allow biopsy prior to neoadjuvant therapy and at the time of fiducial placement
  • Written Authorization for Use and Release of Health and Research Study Information has been obtained
  • Histologically proven adenocarcinoma of the prostate
  • Patients must be candidates for short or long term androgen deprivation in combination with external beam RT based on the following criteria: Intermediate Risk Disease: T2b/c, or Gleason 7, or PSA 10-20; High Risk Disease: Gleason 8-10, or PSA > 20, or T3/4
  • Patients may not have received any prior pharmacologic therapy or RT for prostate cancer
  • ECOG performance status =< 2
  • Karnofsky >= 60%
  • Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the androgen axis will be determined following review of their case by the Principal Investigator
  • Laboratory values must be as follows:
  • White blood cell count: >= 3,000/mm^3
  • Absolute granulocyte count: >= 1,000/mm^3
  • Platelets: >= 100,000/mm^3
  • Hemoglobin >= 10g/dL
  • Potassium >= 3.5 mmol/L
  • Serum creatinine: =< ULN (except for patients with documented Gilbert's disease)
  • ALT < 2.5 x ULN
  • AST < 2.5 x ULN
  • Serum calcium: =< ULN (except for patients with documented Gilbert's disease)
Last Updated
December 21, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.