Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Brachytherapy (100/110); Brachytherapy (125/145); External Beam Radiation Therapy
Intervention description: 100 Gy Palladium-103 (P-102) or 110 Gy Iodine-125 (I-125) seeds within 2-4 weeks of completion of external beam radiotherapy.; 125 Gy Palladium-103 (P-103) or 145 Gy Iodine-125 (I-125) seeds within 4 weeks of study entry.; Total dose of 45 Gy to the prostate and seminal vesicles as a daily dose of 1.8 Gy given 5 times per week. The prescribed dose is defined at the International Commission of Radiation Units and Measurements (ICRU) reference point. Both 3D-conformal radiation therapy (3DCRT) and intensity modulated radiation therapy (IMRT) are permitted.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 588.0
Sex: Male
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage IIB prostate cancer; stage IIA prostate cancer; adenocarcinoma of the prostate

Summary:

      RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells.
      Interstitial brachytherapy uses radioactive material placed directly into or near a tumor to
      kill tumor cells. Combining interstitial brachytherapy with external-beam radiation therapy
      may kill more tumor cells. It is not yet known whether interstitial brachytherapy is more
      effective with or without external-beam radiation therapy in treating prostate cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of interstitial
      brachytherapy with or without external-beam radiation therapy in treating patients who have
      prostate cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the prostate

               -  T1c-T2b, N0, M0

          -  Intermediate-risk disease, as defined by 1 of the following:

               -  Gleason score < 7 AND prostate-specific antigen (PSA) 10-20 ng/mL

               -  Gleason score 7 AND PSA < 10 ng/mL

          -  No evidence of distant metastases

          -  Prostate volume ≤ 60 cc by transrectal ultrasonography

          -  American Urological Association voiding symptom score no greater than 15 (alpha
             blockers allowed)

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Zubrod 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Not specified

        Hepatic

          -  Not specified

        Renal

          -  Not specified

        Other

          -  Patients must use effective contraception

          -  No other malignancy within the past 5 years except basal cell or squamous cell skin
             cancer or carcinoma in situ at any other site

          -  No major medical or psychiatric illness that would preclude study therapy

          -  No hip prosthesis

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No prior chemotherapy

        Endocrine therapy

          -  Prior neoadjuvant hormonal therapy allowed provided the following are true:

               -  Therapy was initiated within 2-6 months of study enrollment

               -  Therapy was no more than 6 months in duration

               -  Use of 5-alpha reductase inhibitors (e.g., finasteride) is discontinued before
                  registration

          -  No concurrent hormonal therapy

        Radiotherapy

          -  No prior pelvic radiotherapy

        Surgery

          -  No prior radical surgery for prostate cancer

          -  No prior transurethral resection of the prostate

          -  No prior cryosurgery

        Other

          -  No prior transurethral needle ablation of the prostate

          -  No prior transurethral microwave thermotherapy of the prostate