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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


Phase 2
30 Years
N/A
Not Enrolling
Male
Prostate Cancer

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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 InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Medical University of South CarolinaCharleston, South Carolina  29425-0721
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Joint Center for Radiation TherapyBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
St. Joseph's Hospital and Medical CenterPaterson, New Jersey  07503