Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology ( Cancer and Leukemia Group B )
ClinicalTrials.gov Identifier:
NCT00006359
First received: October 4, 2000
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: LHRH agonist
Drug: antiandrogen
Radiation: radiation therapy
Radiation: Brachytherapy boost
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Androgen Suppression for 6 Months Combined With External Beam Radiotherapy (EBRT) With Brachytherapy (BT) Boost for Intermediate Risk Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Toxicity [ Time Frame: q 3 mon for 2 yrs post tx initiation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to PSA failure [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    Progression free and overall survival will be assessed


Enrollment: 63
Study Start Date: September 2000
Study Completion Date: March 2012
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006359

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

Additional Information:
Publications:
Hurwitz MD, Halabi S, Archer L, et al.: Combination external beam radiation and brachytherapy boost with androgen suppression for treatment of intermediate-risk prostate cancer: long-term results of CALGB 99809. [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-192, 2010.
Hurwitz MD, Halabi S, Ou SS, et al.: Combination external beam radiation and brachytherapy boost with androgen suppression for treatment of intermediate risk prostate cancer: an initial report of CALGB 99-809. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2230, S337-8, 2006.

Responsible Party: Alliance for Clinical Trials in Oncology ( Cancer and Leukemia Group B )
ClinicalTrials.gov Identifier: NCT00006359     History of Changes
Other Study ID Numbers: CDR0000068228, U10CA031946, CALGB-99809
Study First Received: October 4, 2000
Last Updated: September 25, 2013
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgen Antagonists
Androgens
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hormones

ClinicalTrials.gov processed this record on July 29, 2014