Comparison of Two Radiation Therapy Regimens 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: NCT00062309
Recruitment Status : Completed
First Posted : June 6, 2003
Last Update Posted : March 3, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fox Chase Cancer Center

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays and other sources of radiation to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating prostate cancer.

PURPOSE: This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with stage II or stage III prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: radiation therapy Phase 3

Detailed Description:


  • Compare the efficacy of conventional intensity-modulated radiotherapy (IMRT) vs hypofractionated IMRT, in terms of freedom from biochemical failure in men with intermediate- to high-risk prostate cancer.
  • Compare the local control, freedom from distant metastasis, and overall survival of patients treated with these regimens.
  • Determine local failure, using biopsy of the prostate, when objective tests (prostate-specific antigen, ultrasound, and digital rectal exam) suggest relapse in these patients.
  • Compare the extent of disease eradication using biopsy of the prostate at 2 years after therapy in these patients.
  • Compare the quality of life of patients treated with these regimens.
  • Determine the impact of these regimens on patient preferences and utilities.

OUTLINE: This is a randomized study. Patients are stratified according to pretreatment prostate-specific antigen (no greater than 10 ng/mL vs greater than 10 to 20 ng/mL vs greater than 20 ng/mL), Gleason score (5-7 vs 8-10), and risk status (high risk vs intermediate risk). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo conventional intensity-modulated radiotherapy (IMRT) 5 days a week for 7.5 weeks in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients undergo hypofractionated IMRT 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.

Patients with high-risk disease also undergo androgen deprivation therapy for 2 years.

Quality of life is assessed at baseline, every 6 months for 1 year, and then annually for 4 years.

Patients are followed at 3 months, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study within 3 years.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 307 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Intensity Modulated Radiotherapy Dose Escalation Trial for Prostate Cancer Using Hypofractionation
Study Start Date : June 2002
Actual Primary Completion Date : May 2006

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Active Comparator: CIMRT
76 Gy in 38 fractions
Radiation: radiation therapy
Experimental: HIMRT
70.2 Gy in 26 fractions
Radiation: radiation therapy

Primary Outcome Measures :
  1. Freedom from biochemical and/or disease failure rates [ Time Frame: weekly during treatment, at 3 months, 6 months or 2 years then yearly ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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


  • Histologically confirmed adenocarcinoma of the prostate

    • Clinical stage T1b-T3c disease
    • No clinical or radiographic evidence of metastasis
  • Prostate-specific antigen (PSA) less than 80 ng/mL
  • Gleason score at least 5
  • One of the following criteria must be met:

    • PSA greater than 10 ng/mL
    • Gleason score greater than 6
    • T2b or greater palpable disease
    • Three or more biopsy cores involved with a Gleason score of at least 5



  • Not specified

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No other medical condition that would preclude study participation
  • No other active malignancy within the past 5 years except nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic leukemia)
  • Fertile patients must use effective contraception


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • No more than 4 months of prior androgen deprivation therapy
  • Neoadjuvant and adjuvant androgen deprivation therapy is allowed for high-risk disease only


  • No prior pelvic radiotherapy


  • No prior or planned radical prostate surgery

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): NCT00062309

United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Sponsors and Collaborators
Fox Chase Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Mark Buyyounouski, MD Fox Chase Cancer Center

Pollack A, Bae K, Khor LY, et al.: Stability of tumor biomarkers in archival tissue from men treated with radiotherapy for prostate cancer: an analysis of RTOG 92-02 and Fox Chase randomized trials. [Abstract] Int J Biol Markers 22 (1): 72-3, 2006.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Fox Chase Cancer Center Identifier: NCT00062309     History of Changes
Other Study ID Numbers: CDR0000304712
P30CA006927 ( U.S. NIH Grant/Contract )
First Posted: June 6, 2003    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: March 2016

Keywords provided by Fox Chase Cancer Center:
stage II prostate cancer
stage III prostate cancer
adenocarcinoma of the prostate

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