RATIONALE: Imaging procedures such as MRI may improve the ability to determine the response of prostate tumors to therapy. PURPOSE: Phase II trial to study MRI results in patients with prostate cancer that has been treated with radiation therapy plus androgen suppression therapy.

Condition	Treatment or Intervention	Phase
stage II prostate cancer stage III prostate cancer stage I prostate cancer adenocarcinoma of the prostate	Drug: flutamide  Drug: goserelin  Drug: leuprolide	Phase II

Further Study Details: 

OBJECTIVES: I. Establish whether changes between baseline and 2-month post androgen suppression endorectal coil MRI results predict for biochemical control following radiotherapy with androgen suppression in patients with adenocarcinoma of the prostate.

PROTOCOL OUTLINE: Patients undergo a baseline endorectal coil MRI, followed by total androgen suppression (TAS) with either leuprolide IM or subcutaneous goserelin once a month plus oral flutamide 3 times a day for 2 months. Patients then receive a second endorectal coil MRI, followed by 2 months of external-beam radiotherapy plus TAS. Patients may receive an additional 2 months of TAS at the discretion of the treating physician. Patients are followed every 6 months for 3 years, then yearly thereafter.

PROJECTED ACCRUAL: Approximately 180 patients (approximately 60 per year) will be accrued for this study over a 34 months.

Ages Eligible for Study:  30 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed adenocarcinoma of the prostate; AJCC stage T1b-T4b, N0 or Nx, M0; Transrectal, transperineal, or transurethral biopsy required

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior chemotherapy for carcinoma of the prostate
• Endocrine therapy: No prior androgen deprivation therapy (medical or surgical)
• Radiotherapy: No prior radiation therapy for carcinoma of the prostate
• Surgery: No prior surgical androgen deprivation therapy

--Patient Characteristics--

• Age: 30 and over
• Performance status: CALGB 0-2
• Hematopoietic: Not specified
• Hepatic: Not specified
• Renal: Not specified
• Other: The following may increase the risk of protocol treatment: Serious intercurrent medical illness that might compromise patient safety; Active acute infection requiring antibiotics; Suppression therapy for chronic urinary tract infection allowed; Uncontrolled or severe cardiovascular disease; Psychiatric conditions that prevent compliance or informed consent

California
      UCSF Cancer Center and Cancer Research Institute, San Francisco,  California,  94115-0128,  United States
District of Columbia
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5000,  United States
Illinois
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637,  United States
Massachusetts
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States
      Joint Center for Radiation Therapy, Boston,  Massachusetts,  02215,  United States
New Jersey
      St. Joseph's Hospital and Medical Center, Paterson,  New Jersey,  07503,  United States
New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States
North Carolina
      Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston Salem,  North Carolina,  27157-1082,  United States
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States
Ohio
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210,  United States
South Carolina
      Medical University of South Carolina, Charleston,  South Carolina,  29425-0721,  United States

Study chairs or principal investigators

Anthony Victor D'Amico,  Study Chair,  Cancer and Leukemia Group B   

Study ID Numbers:  CDR0000065212; CLB-9682
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002889
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08