Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2025-12-26 @ 5:22 PM
NCT ID:
NCT01923506
Brief Summary:
This phase I trial studies the side effects and best dose of stereotactic body radiation therapy in treating patients with prostate cancer after undergoing surgery. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) with an upper limit of 45 Gray (Gy) in 5 fractions, in the delivery of stereotactic body radiation therapy (SBRT) to the prostate fossa.
SECONDARY OBJECTIVES:
I. To assess acute and late toxicities from treatment.
II. To assess biochemical progression-free survival.
III. To collect prospective quality-of-life data related to bowel, urinary, and sexual health.
OUTLINE: This is a dose-escalation study.
Patients receive 5 fractions of SBRT over 1.5 weeks.
After completion of study treatment, patients are followed up at 90 days and then periodically for 3 years.
Study:
NCT01923506
Study Brief:
Protocol Section:
NCT01923506