Radiation Therapy With Androgen Suppression in Treating Patients With Prostate Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

February 6, 2009

Start Date ^ICMJE

May 1997

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00002889 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Radiation Therapy With Androgen Suppression in Treating Patients With Prostate Cancer

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Drug: flutamide
Drug: goserelin
Drug: leuprolide acetate
Radiation: low-LET photon therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

180

Completion Date

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

30 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00002889

Responsible Party

Study ID Numbers ^ICMJE

CDR0000065212, CLB-9682

Study Sponsor ^ICMJE

Cancer and Leukemia Group B

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Anthony V. D'Amico, MD, PhD

Joint Center for Radiation Therapy

Information Provided By

National Cancer Institute (NCI)

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP