Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer

January 3, 2014 updated by: Herbert Irving Comprehensive Cancer Center

Phase II Trial of Maximal Androgen Deprivation Followed by Conformal External Beam Radiotherapy With Continued Androgen Deprivation for Clinically Localized Prostate Cancer

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of androgens. Combining radiation therapy with hormone therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of hormone therapy plus radiation therapy in treating patients with prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Assess the disease free survival of patients with localized adenocarcinoma of the prostate cancer.
  • Evaluate the toxic effects of three dimensional conformal external beam radiotherapy and androgen deprivation in these patients.

OUTLINE: Patients are stratified according to PSA values and Gleason scores (class II versus class III/IV).

Patients receive intramuscular leuprolide acetate every 3 months, and oral flutamide tid.

Patients are evaluated on a monthly basis for response. Patients with unchanged or undetectable prostate specific antigen levels are considered to have reached maximal hormonal response and three dimensional conformal external beam radiotherapy is instituted. In addition, patients with disease progression are considered to have reached maximal response, and three dimensional conformal external beam radiotherapy is instituted. Radiotherapy must be administered within 6 months after initiation of leuprolide and flutamide therapy.

Hormonal therapy is administered until 9 months of treatment have elapsed.

Patients will be followed every 3 months for the first year, every 4 months for the second and third years, and every 6 months thereafter.

PROJECTED ACCRUAL: A total of 105 patients will be accrued from biologic class II over 3 years, and 58 patients from biologic class III-IV.

Study Type

Interventional

Enrollment (Anticipated)

105

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • Histologically proven localized adenocarcinoma of the prostate

    • Prostate specific antigen (PSA) greater than 4 or Gleason score at least 8 if PSA is no greater than 4
    • CT, MRI, or pelvic lymphadenectomy negative for metastases, if PSA is no greater than 50
    • Negative pelvic lymphadenectomy, if PSA is greater than 50
    • Bone scan negative for metastases or PSA no greater than 20

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance Status:

  • Not specified

Life Expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,000/mm3
  • Platelet count at least 70,000/mm3
  • Hemoglobin at least 10 g/dL
  • Patients on anticoagulant therapy must have a baseline PT test

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • ALT or AST less than 1.5 times ULN
  • Alkaline phosphatase less than 1.5 times ULN

Renal:

  • Creatinine less than 1.5 times ULN

Cardiovascular:

  • No history of collagen vascular disease

Other:

  • No acute infection requiring antibiotics
  • No history of hypersensitivity to flutamide
  • No history of hypersensitivity to leuprolide acetate

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herbert Irving Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Ronald D. Ennis, MD, Herbert Irving Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1997

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

April 17, 2003

First Posted (Estimate)

April 18, 2003

Study Record Updates

Last Update Posted (Estimate)

January 6, 2014

Last Update Submitted That Met QC Criteria

January 3, 2014

Last Verified

December 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065883
  • CPMC-IRB-7947
  • NCI-G97-1356

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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