Internal Radiation Therapy With or Without External-Beam Radiation Therapy in Treating Patients With Localized Prostate Cancer
Internal Radiation Therapy With or Without External-Beam Radiation Therapy in Treating Patients With Localized Prostate Cancer
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.
OBJECTIVES:

 Primary

 -  Evaluate the tolerability of 2 radiotherapeutic regimens (high dose-rate brachytherapy
 [HDR] with or without image-guided intensity-modulated hypofractionated external beam
 radiotherapy [EBRT]), as measured by the Common Terminology Criteria for Adverse Events
 (CTCAE v3.0), in patients with localized prostate cancer.

 Secondary

 -  Identify any associations between dose-volume parameters for organs at risk and the rate
 and severity of genitourinary or gastrointestinal adverse events.

 -  Evaluate patient preference with regard to selection of a second treatment (a second HDR
 brachytherapy session or an EBRT session).

 -  Evaluate patient-reported health-related quality of life (HRQOL) as measured by
 validated HRQOL instruments for 5 years.

 -  Describe the probability of freedom from biochemical and clinical failure.

 -  Describe the probability of freedom from salvage androgen suppression.

 OUTLINE: Patients undergo high dose-rate (HDR) brachytherapy (2 fractions ≥ 5 hours apart).
 Beginning 2-4 weeks after completion of the first HDR brachytherapy session, patients undergo
 either a second session of HDR brachytherapy (2 fractions ≥ 5 hours apart) OR image-guided
 intensity-modulated hypofractionated external beam radiotherapy once daily 5 days a week for
 3 weeks.

 Quality of life is assessed at baseline, prior to the second treatment session, at 1 and 6
 months after completion of treatment, every 6 months for 3 years, and then annually for 2
 years.

 After completion of study treatment, patients are followed at 1 and 6 months, every 6 months
 for 3 years, and then annually for 2 years.
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