PROGNOSTIC SIGNIFICANCE OF ENDORECTAL MRI IN PREDICTING OUTCOME AFTER COMBINED RADIATION AND ANDROGEN SUPPRESSION FOR PROSTATE CANCER: A PROSPECTIVE PHASE II STUDY
30 Years
N/A
Male
Prostate Cancer
Trial Information
PROGNOSTIC SIGNIFICANCE OF ENDORECTAL MRI IN PREDICTING OUTCOME AFTER COMBINED RADIATION AND ANDROGEN SUPPRESSION FOR PROSTATE CANCER: A PROSPECTIVE PHASE II STUDY
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy
Outcome Time Frame:
2 years post tx
Safety Issue:
No
Principal Investigator
Anthony V. D'Amico, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Joint Center for Radiation Therapy
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000065212
NCT ID:
NCT00002889
Start Date:
May 1997
Completion Date:
June 2009
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage I prostate cancer
- stage II prostate cancer
- stage III prostate cancer
- stage IV prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157-1082 |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
| Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
| UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
| Joint Center for Radiation Therapy | Boston, Massachusetts 02215 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| St. Joseph's Hospital and Medical Center | Paterson, New Jersey 07503 |
