Pilot Evaluation of High Dose-Rate Brachytherapy ± Image-Guided Intensity Modulated Hypofractionated External Radiotherapy for Localized Prostate Cancer
- 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.
- 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
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.
Primary Purpose: Treatment
Treatment tolerance (genitourinary [GU] or gastrointestinal [GI] adverse events)
Thomas M. Pisansky, MD
United States: Federal Government
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