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Radiation Therapy in Treating Patients With Stage I, 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: NCT00258466
Recruitment Status : Withdrawn
First Posted : November 24, 2005
Last Update Posted : April 8, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. It is not yet known which type of radiation therapy is more effective in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying different types of radiation therapy to compare how well they work in treating patients with stage I, 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 neutron and photon radiotherapy vs hypofractionated intensity modulated radiation, in terms of a lower frequency of chronic complication rate (chronic toxicity and disease-free survival), in patients with favorable to intermediate prognosis, stage I-III adenocarcinoma of the prostate.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage of disease (T1 vs T2 vs T3). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo neutron radiotherapy over 15-45 minutes 5 days a week for 2 weeks followed by photon radiotherapy over 15-45 minutes 5 days a week for 5 weeks.
  • Arm II: Patients undergo photon radiotherapy over 15-45 minutes 5 days a week for 5 weeks followed by hypofractionated photon irradiation over 15-45 minutes 5 days a week for 2 weeks.

After completion of study treatment, patients are followed periodically for 5 years and then yearly thereafter.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase III Trial of Neutron + Photon Radiation Versus Photon + Hypofractionated Intensity Modulated Radiation Therapy in Localized Prostate Cancer
Study Start Date : May 2005
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Primary Outcome Measures :
  1. Occurrence of chronic grade 2 or higher toxicity as measured by RTOG/EORTC late morbidity scoring scheme at 1, 4, 8, and 12 months after treatment, then every 6 months for 5 years, then annually

Secondary Outcome Measures :
  1. Disease free survival at 1, 4, 8, and 12 months after treatment, then every 6 months for 5 years, then annually

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.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the prostate

    • Stage I-III disease (T1-T3, N0, M0)
    • No clinical or radiographic evidence of metastasis

      • If prostate-specific antigen (PSA) ≥ 10.0 ng/mL and Gleason score is 7, a radioisotope bone scan must show no evidence of metastasis
      • No evidence of lymphatic or visceral metastases of the abdomen or pelvis on CT scan or MRI
  • PSA ≤ 20 ng/mL
  • Gleason score ≤ 7 (if stage T3 , score must be < 7)


Performance status

  • Not specified

Life expectancy

  • More than 10 years


  • Not specified


  • Not specified


  • Not specified


  • No other malignancy within the past 5 years except basal cell or squamous cell skin cancer


Endocrine therapy

  • Prior hormonal therapy allowed provided it was initiated no more than 2 months ago, and may include the following:

    • Luteinizing hormone-releasing hormone agonists (e.g., goserelin, leuprolide)
    • Anti-androgens (e.g., flutamide, bicalutamide)


  • No prior pelvic irradiation


  • No prior radical prostatectomy

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): NCT00258466

Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
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Study Chair: Jeffrey D. Forman, MD, FACR Weisberg Cancer Treatment Center

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Responsible Party: Barbara Ann Karmanos Cancer Institute Identifier: NCT00258466    
Other Study ID Numbers: CDR0000447161
P30CA022453 ( U.S. NIH Grant/Contract )
First Posted: November 24, 2005    Key Record Dates
Last Update Posted: April 8, 2013
Last Verified: April 2013
Keywords provided by Barbara Ann Karmanos Cancer Institute:
adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases