Prostate Cancer Clinical Trials
Adenocarcinoma of the Prostate
Stage II Prostate Cancer
Stage III Prostate Cancer
Stage IV Prostate Cancer
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.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- 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)
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
- 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.