Radiation Therapy With Androgen Suppression in Treating Patients With Prostate Cancer



Status:Completed
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:30 - Any
Updated:6/29/2016
Start Date:May 1997
End Date:June 2009

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PROGNOSTIC SIGNIFICANCE OF ENDORECTAL MRI IN PREDICTING OUTCOME AFTER COMBINED RADIATION AND ANDROGEN SUPPRESSION FOR PROSTATE CANCER: A PROSPECTIVE PHASE II STUDY

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.

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.

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.

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

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

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
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