NCT00450411

Ultrasound-Guided Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer Previously Treated With External-Beam Radiation Therapy

A Prospective Phase II Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: Male
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. PURPOSE: This phase II trial is studying the side effects and how well ultrasound-guided implant radiation therapy works in treating patients with locally recurrent prostate cancer previously treated with external-beam radiation therapy.

Detailed description

OBJECTIVES: Primary * Determine the late treatment-related gastrointestinal (GI) and genitourinary (GU) adverse events in patients with locally recurrent adenocarcinoma of the prostate previously treated with external-beam radiotherapy who are currently receiving transperineal ultrasound-guided iodine I 125 or palladium Pd 103 brachytherapy. Secondary * Determine the acute treatment-related GI and GU adverse events in patients treated with this regimen. * Determine the overall survival of patients treated with this regimen. * Determine the disease-free survival of patients treated with this regimen. * Determine the disease-specific survival of patients treated with this regimen. * Determine clinical patterns of tumor recurrence (time to local tumor progression or distant failure) in patients treated with this regimen. * Determine the time to biochemical failure in patients treated with this regimen. * Determine the post-brachytherapy dosimetric coverage in patients treated with this regimen. OUTLINE: This is a prospective, multicenter study. Patients undergo transperineal ultrasound-guided iodine I 125 or palladium Pd 103 brachytherapy. Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	125-Iodine	Brachytherapy to the prostate via 125-iodine (I-125) seeds with a planned dose of 140 Gy
RADIATION	103-palladium	Brachytherapy to the prostate via 103-palladium (Pd-103) seeds with a planned dose of 120 Gy

Timeline

• Start date: 2007-05-01
• Primary completion: 2016-06-01
• Completion: 2022-05-20
• First posted: 2007-03-22
• Last updated: 2022-06-21
• Results posted: 2017-11-07

Locations

17 sites across 2 countries: United States, Canada