Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer

July 15, 2016 updated by: Alliance for Clinical Trials in Oncology

Phase II Trial of Androgen Suppression for 6 Months Combined With External Beam Radiotherapy (EBRT) With Brachytherapy (BT) Boost for Intermediate Risk Prostate Cancer

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving these drugs together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well androgen suppression with either leuprolide or goserelin and either flutamide or bicalutamide together with radiation therapy works in treating patients with prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the feasibility of androgen-suppression therapy combined with external-beam radiotherapy and boost brachytherapy (EBRT+BT) in patients with intermediate-risk localized prostate cancer.
  • Determine the safety of EBRT+BT in these patients.
  • Determine, in a preliminary manner, the efficacy of EBRT+BT in terms of rate of local recurrence at 5 years, time to prostate-specific antigen failure, and time to first rectal/bladder injury, in these patients.

OUTLINE: Patients receive either leuprolide intramuscularly or goserelin subcutaneously once every 12 weeks for a total of 24 weeks. Patients also receive either oral flutamide three times daily or oral bicalutamide once daily for 4 weeks.

Within 4 weeks after initiation of androgen-suppression therapy, patients undergo external-beam radiotherapy (EBRT) once daily, 5 days a week, for 5 weeks. At 2-4 weeks after completion of EBRT, patients undergo transrectal ultrasound-guided boost brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds.

Patients are followed every 3 months for 2 years and then every 6 months for 4 years.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

63

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
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Beebe Medical Center
      • Newark, Delaware, United States, 19718
        • CCOP - Christiana Care Health Services
      • Wilmington, Delaware, United States, 19805
        • St. Francis Hospital
    • Florida
      • Orlando, Florida, United States, 32803
        • Florida Hospital Cancer Institute at Florida Hospital Orlando
    • Maryland
      • Elkton MD, Maryland, United States, 21921
        • Union Hospital Cancer Center at Union Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
      • Fall River, Massachusetts, United States, 02721
        • Hudner Oncology Center at Saint Anne's Hospital
      • Worcester, Massachusetts, United States, 01655
        • UMASS Memorial Cancer Center - University Campus
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Kansas City, Missouri, United States, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, United States, 63141
        • Arch Medical Services, Incoroporated at Center for Cancer Care Research
      • St. Louis, Missouri, United States, 63131
        • Missouri Baptist Cancer Center
    • Nevada
      • Reno, Nevada, United States, 89502
        • Washoe Cancer Services at Washoe Medical Center - Reno
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • Syracuse, New York, United States, 13210
        • Veterans Affairs Medical Center - Syracuse
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University Hospital
      • Syracuse, New York, United States, 13057
        • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
      • Syracuse, New York, United States, 13215
        • Community General Hospital of Greater Syracuse
    • North Carolina
      • Charlotte, North Carolina, United States, 28233
        • Presbyterian Cancer Center at Presbyterian Hospital
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Memorial Hospital, Incorporated
      • Wilmington, North Carolina, United States, 28401
        • Zimmer Cancer Center at New Hanover Regional Medical Center
      • Winston-Salem, North Carolina, United States, 27157
        • Comprehensive Cancer Center at Wake Forest University
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
    • Virginia
      • Danville, Virginia, United States, 24541
        • Danville Regional Medical 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

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • Must have one of the following prognostic factors:

      • Stage T1-2, N0; prostate-specific antigen (PSA) ≤ 10 ng/mL; and Gleason score > 6
      • Stage T1-2, N0; PSA > 10 ng/mL and < 20 ng/mL; and Gleason score ≤ 6
      • Stage T3a, N0; PSA ≤ 10 ng/mL; and Gleason score ≤ 6
  • Prostate volume < 60 cc by transrectal ultrasound

  • No distant or nodal metastases

    • No metastatic disease by bone scan, CT scan, or MRI

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic:

  • Bilirubin ≤ 1.5 times upper limit of normal

Renal:

  • Not specified

Other:

  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy for prostate cancer

Chemotherapy:

  • No prior chemotherapy for prostate cancer

Endocrine therapy:

  • Prior androgen-suppression therapy for up to 4 weeks duration allowed if initiated within 4 weeks of study radiotherapy
  • No other prior hormonal therapy

Radiotherapy:

  • No prior radiotherapy for prostate cancer

Surgery:

  • No prior surgery for prostate cancer
  • No prior transurethral resection of the prostate

Other:

  • No prior alternative therapy (e.g., PC-SPES) for prostate cancer

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
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Androgen suppression + EBRT + Brachytherapy
Androgen suppression with external beam radiation therapy followed by brachytherapy boost
Drug: LHRH agonist
Lupron: 22.5mg IM injection q 12 wks x 2 OR Zoladex: 10.8 mg subQ injection q 12 wks x 2
Drug: antiandrogen
flutamide 250 mg PO tid for 4 wks OR casodex 50 mg PO daily for 4 wks
Radiation: radiation therapy
4500 cGy total dose given days 1-5 for 5 weeks following initiation of androgen suppression (25 fractions)
Radiation: Brachytherapy boost
Iodine 125 0.3 to 0.5 U per seed OR palladium 103 1.04 to 1.4 U per seed as implant; prescribed dose of I-125 100 Gy (TG-43) and Pd-103 90 Gy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Toxicity
Time Frame: q 3 mon for 2 yrs post tx initiation
q 3 mon for 2 yrs post tx initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to PSA failure
Time Frame: 6 years
6 years
Survival
Time Frame: 6 years
Progression free and overall survival will be assessed
6 years

Collaborators and Investigators

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

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Mark Hurwitz, MD, Dana-Farber/Brigham and Women's 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

September 1, 2000

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

October 4, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 18, 2016

Last Update Submitted That Met QC Criteria

July 15, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALGB-99809
  • U10CA031946 (U.S. NIH Grant/Contract)
  • CDR0000068228 (Registry Identifier: NCI Physician Data Query)

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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