Expired Study
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Rochester, Minnesota 55905


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00714753


Primary Contact:

Principal Investigator
Thomas M. Pisansky, MD
Mayo Clinic


Backup Contact:

N/A


Location Contact:

Rochester, Minnesota 55905
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 22, 2018

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