Radiation Therapy in Treating Patients With Stage II Prostate Cancer

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentClosedAny ageNCI, OtherRTOG-0126
CDR0000069306, NCT00033631

Trial Description


RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating stage II prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different doses of specialized radiation therapy in treating patients who have stage II prostate cancer.

Further Study Information


  • Compare the overall survival of patients with stage II adenocarcinoma of the prostate treated with high- vs standard-dose three-dimensional conformal or intensity-modulated radiotherapy.
  • Compare the freedom from prostate-specific antigen failure, disease-specific survival, local progression, and distant metastases in patients treated with these regimens.
  • Compare the probability of tumor control and normal tissue complications in patients treated with these regimens.
  • Compare the incidence of grade 2 or greater genitourinary and gastrointestinal acute and late toxicity in patients treated with these regimens.
  • Compare the quality of life, including sexual function, of patients treated with these regimens.
  • Correlate histopathologic or tumor-specific cytogenetic or chromosomal markers with cancer control outcomes in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Gleason score and prostate-specific antigen (PSA) level (Gleason score 2-6, PSA ≥10 mg/mL but < 20 ng/mL vs Gleason score 7, PSA < 15 ng/mL) and radiation modality (three-dimensional conformal radiotherapy [3D-CRT] vs intensity-modulated radiotherapy [IMRT]). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo standard-dose 3D-CRT or IMRT once daily, 5 days a week, for 7.8 weeks (39 treatment days).
  • Arm II: Patients undergo high-dose 3D-CRT or IMRT once daily, 5 days a week, for 8.8 weeks (44 treatment days).

Quality of life (QOL) is assessed initially at baseline. After completion of radiotherapy, QOL is assessed every 3 months for 1 year and then every 6 months for 4 years.

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

PROJECTED ACCRUAL: A total of 1,520 patients (760 per treatment arm) will be accrued for this study within 5 years.

Eligibility Criteria


  • Histologically confirmed adenocarcinoma of the prostate
  • Clinical stage T1b-T2b
  • Meets one of the following criteria:
  • Gleason score 2-6 AND prostate-specific antigen (PSA) ≥ 10 ng/mL but < 20 ng/mL
  • Gleason score 7 AND PSA < 15 ng/mL
  • No regional lymph node involvement
  • No distant metastases



  • Any age

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No other invasive malignancy within the past 5 years except localized basal cell or squamous cell skin cancer
  • No other major medical or psychiatric illness that would preclude study participation
  • Fertile patients must use effective contraception


Biologic therapy:

  • Not specified


  • No prior cytotoxic chemotherapy
  • No concurrent cytotoxic chemotherapy

Endocrine therapy:

  • At least 3 months since prior finasteride
  • No other prior hormonal therapy, including:
  • Luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide)
  • Antiandrogens (e.g., flutamide or bicalutamide)
  • Estrogens (e.g., diethylstilbestrol)
  • No concurrent (neoadjuvant or adjuvant) hormonal therapy


  • No prior pelvic irradiation or prostatic brachytherapy


  • No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer
  • No prior surgical castration (bilateral orchiectomy)


  • At least 3 months since prior finasteride or PC SPES

Trial Contact Information

Trial Lead Organizations/Sponsors

Radiation Therapy Oncology Group

  • National Cancer Institute
Jeff M. Michalski, Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00033631
ClinicalTrials.gov processed this data on January 22, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.