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.
Radiation: hypofractionated radiation therapy
Radiation: image-guided radiation therapy
Radiation: intensity-modulated radiation therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Evaluation of High Dose-Rate Brachytherapy ± Image-Guided Intensity Modulated Hypofractionated External Radiotherapy for Localized Prostate Cancer|
- Treatment tolerance (genitourinary [GU] or gastrointestinal [GI] adverse events) [ Designated as safety issue: Yes ]
- Association between dose-volume limitations for organs at risk and rate and severity of GU or GI adverse events [ Designated as safety issue: Yes ]
- Patient preference for a second treatment (a second high dose-rate brachytherapy session or an external beam radiotherapy session) [ Designated as safety issue: No ]
- Changes in health-related quality of life scores [ Designated as safety issue: No ]
- Freedom from biochemical and clinical failure [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Disease-free survival [ Designated as safety issue: No ]
- Disease-specific survival [ Designated as safety issue: No ]
- Time to local tumor progression [ Designated as safety issue: No ]
- Distant failure [ Designated as safety issue: No ]
- Freedom from salvage androgen suppression treatment [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00714753
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Thomas M. Pisansky, MD||Mayo Clinic|