Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00091390
Recruitment Status : Completed
First Posted : September 9, 2004
Results First Posted : November 14, 2014
Last Update Posted : June 1, 2017
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving internal radiation therapy together with external-beam radiation therapy works in treating patients with stage II or stage III prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: HDR brachytherapy boost Radiation: radiation therapy Phase 2

Detailed Description:



  • Determine the rate of late grade 3 or greater genitourinary and gastrointestinal toxicity after treatment with external beam radiotherapy and high-dose rate brachytherapy in patients with stage II or III adenocarcinoma of the prostate.


  • Determine acute grade 3 or greater genitourinary and gastrointestinal toxicity in patients treated with this regimen.
  • Determine freedom from biochemical failure in patients treated with this regimen.
  • Determine overall survival of patients treated with this regimen.
  • Determine disease-specific survival of patients treated with this regimen.
  • Determine clinical relapse (local and/or distant) in patients treated with this regimen.
  • Develop a quality assurance process for high-dose rate prostate brachytherapy.

OUTLINE: This is a multicenter study. Patients are stratified according to prostate-specific antigen (≤ 10 ng/mL vs 11-20 ng/mL), T stage (T1c-T2c vs T3a-T3b), combined Gleason score (2-6 vs 7 vs 8-10), prior hormonal therapy (no vs yes), and timing of high-dose rate brachytherapy (before external beam radiotherapy vs after external beam radiotherapy).

Patients undergo external beam radiotherapy over approximately 15 minutes once daily 5 days a week for 5 weeks. Patients also receive two fractions (within a 24-hour period) of high-dose rate brachytherapy (delivered through an implant inserted into the prostate) over approximately 5-30 minutes either before or after external beam radiotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3, 7, 9, and 12 months, every 6 months for 5 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study within 1 year.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial Of Combined High Dose Rate Brachytherapy And External Beam Radiotherapy For Adenocarcinoma Of The Prostate
Study Start Date : July 2004
Actual Primary Completion Date : January 2008
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: EBRT and HDR brachytherapy boost
External beam radiation therapy (EBRT) and high dose rate (HDR) brachytherapy boost.
Radiation: HDR brachytherapy boost
Brachytherapy could be performed before or after the external beam radiotherapy. The overall treatment course (external beam radiotherapy and brachytherapy) was limited to no longer than 8 weeks. 19 Gy in two fractions was to be given only to the clinical target volume (CTV). The first HDR treatment was to be delivered on the day of the catheter placement. The second treatment was to be delivered within 24 hours after the first treatment, but no less than 6 hours between implants.
Radiation: radiation therapy
1.8 Gy given five times per week for a total dose of 45 Gy.

Primary Outcome Measures :
  1. Late Severe Genitourinary (GU) and Gastrointestinal (GI) Toxicity at 18 Months [ Time Frame: Beginning nine months after start of treatment. ]
    Eighteen-month rate of late severe (grade 3-5) genitourinary (GU) and gastrointestinal (GI) toxicity, defined as starting more than 9 months from treatment start, and graded by CTCAE v3.0

Secondary Outcome Measures :
  1. Acute Severe GU and GI Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Within 9 Months of Starting Treatment [ Time Frame: From registration until 9 months from the start of treatment ]
  2. Biochemical Failure [ Time Frame: From registration to the date of biochemical failure or last follow-up. Analysis occurs after each patient has had 3 years of follow-up. ]
  3. Overall Survival [ Time Frame: From registration to the date of death or last follow-up. Analysis occurs after each patient has had 3 years of follow-up. ]
  4. Disease-specific Survival [ Time Frame: From registration to the date of death due to prostate cancer or other disease related cause. Analysis occurs after each patient has had 3 years of follow-up. ]
  5. Clinical Progression Including Local/Regional and Distant Relapse [ Time Frame: From registration to the date of local/regional progression or distant relapse, or last follow-up. Analysis occurs after each patient has had 3 years of follow-up. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the prostate

    • Clinical stage T1c-T3b
    • No clinically or pathologically involved lymph nodes (N0 by pelvic CT scan or MRI)
    • No distant metastases (M0 by negative bone scan)
  • Meets one of the following combination criteria:

    • Clinical stage T1c-T2c, Gleason score 2-6, and prostate-specific antigen (PSA) > 10 but ≤ 20 ng/mL
    • Clinical stage T3a-T3b, Gleason score 2-6, and PSA ≤ 20 ng/mL
    • Clinical stage T1c-T3b, Gleason score 7-10, and PSA ≤ 20 ng/mL



  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • Fertile patients must use effective contraception
  • No hip prosthesis
  • No major medical or psychiatric illness that would preclude study participation
  • No prior invasive malignancy except nonmelanomatous skin cancer (e.g., carcinoma in situ of the oral cavity or bladder) or any other malignancy with a disease-free status ≥ 3 years


Biologic therapy

  • Not specified


  • No prior chemotherapy for prostate cancer

Endocrine therapy

  • Prior induction hormonal therapy allowed provided therapy was initiated within 90 days before study enrollment


  • No prior pelvic or prostate radiotherapy
  • No concurrent intensity-modulated radiotherapy


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00091390

United States, California
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
Inglewood, California, United States, 90301
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States, 95815
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
United States, Florida
Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center
Boca Raton, Florida, United States, 33486
United States, Illinois
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
United States, Maine
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, United States, 04074
United States, Michigan
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
United States, New Jersey
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
United States, Wisconsin
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States, 53188
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
NRG Oncology
Study Chair: I-Chow J. Hsu, MD University of California, San Francisco

Publications of Results:
Responsible Party: Radiation Therapy Oncology Group Identifier: NCT00091390     History of Changes
Other Study ID Numbers: RTOG-0321
First Posted: September 9, 2004    Key Record Dates
Results First Posted: November 14, 2014
Last Update Posted: June 1, 2017
Last Verified: December 2016

Keywords provided by Radiation Therapy Oncology Group:
adenocarcinoma of the prostate
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases