Radiation Therapy in Treating Patients With Stage II Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: 70.2 Gy 3D-CRT/IMRT; 79.2 Gy 3D-CRT/IMRT
Intervention description: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.; Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1534.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; stage IIB prostate cancer; stage IIA prostate cancer

Summary:

      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.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  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

        PATIENT CHARACTERISTICS:

        Age:

          -  Any age

        Performance status:

          -  Zubrod 0-1

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Not specified

        Hepatic:

          -  Not specified

        Renal:

          -  Not specified

        Other:

          -  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

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  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

        Radiotherapy:

          -  No prior pelvic irradiation or brachytherapy

        Surgery:

          -  No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer

          -  No prior surgical castration (bilateral orchiectomy)

        Other:

          -  At least 3 months since prior finasteride or phytoestrogen preparation (PC-SPES)