Internal Radiation Therapy With or Without External-Beam Radiation Therapy in Treating Patients With Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: brachytherapy; hypofractionated radiation therapy; image-guided radiation therapy; intensity-modulated radiation therapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: Male
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage I prostate cancer; stage II prostate cancer; adenocarcinoma of the prostate

Summary:

      RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor
      to kill tumor cells. 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.

      PURPOSE: This phase II trial is studying the side effects of internal radiation therapy when
      given with or without external-beam radiation therapy and to see how well it works in
      treating patients with localized prostate cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the prostate, meeting one of the following
             criteria:

               -  Low-risk disease (T1-T2a, Gleason score ≤ 6, and PSA < 10 ng/mL)

               -  Low intermediate-risk disease (T1-T2c, Gleason score ≤ 6, and PSA < 20 ng/mL OR
                  T1-T2a, Gleason score 7, and PSA < 10 ng/mL)

          -  No known nodal (N0 or NX) or distant (M0 or MX) metastases

          -  No pubic arch interference, as defined by either of the following:

               -  Maximum transrectal ultrasound-determined anterior-posterior (z-axis) dimension <
                  4.3 cm

               -  No more than 25% prostate volume blocked (by pubic arch) on CT scan simulation at
                  A10°I beam's eye view

          -  Prostate planimetry volume ≤ 60 cc as determined by step-section transrectal
             ultrasound

          -  American Urological Association voiding symptom index ≤ 12

          -  Peak uroflow rate (Q_max) ≥ 12 cc/second

          -  Post-void ultrasound bladder residual volume ≤ 100 cc

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status 0-1

          -  Life expectancy ≥ 5 years

          -  WBC > 2,000/μL

          -  Platelet count > 100,000/μL

          -  PT < 1.5 times upper limit of normal

          -  No diabetes mellitus associated with vascular ulcers or wound-healing problems

          -  No blood dyscrasias

          -  No inflammatory bowel disease

          -  No connective tissue disorder

          -  No other prior or concurrent invasive malignancy (except nonmelanoma skin cancer) or
             lymphomatous or hematological malignancy (except chronic lymphocytic
             leukemia/lymphoma) unless patient has been continually disease-free for ≥ 5 years

          -  No medical or psychiatric condition that would preclude giving informed consent or
             complying with study treatment

          -  Able to undergo anesthesia

        PRIOR CONCURRENT THERAPY:

          -  No prior transurethral resection of the prostate

          -  No prior prostatic cryoablation or high-intensity focused ultrasound

          -  No prior prostatectomy

          -  No prior prostatic enucleation

          -  No prior pelvic external beam radiotherapy

          -  No prior radionuclide prostate brachytherapy

          -  No prior hemi- or total hip arthroplasty

          -  Neoadjuvant androgen suppression therapy allowed provided it was initiated 2-6 months
             prior to study entry and its total duration is ≤ 6 months

          -  No concurrent anticoagulation therapy, including heparin or coumadin