Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Mayo Clinic
With
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.
Age
18–120
Sex
MALE
Healthy volunteers
Not accepted
