internal radiation therapy with or without external-beam radiation therapy in treating patients with localized prostate cancer

Conditions: Prostate Cancer

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.

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.

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

Keywords: stage i prostate cancer stage ii prostate cancer adenocarcinoma of the prostate