Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer After Undergoing Surgery
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 30
Summary
- Conditions
- Recurrent Prostate Cancer
- Stage I Prostate Cancer
- Stage IIA Prostate Cancer
- Stage IIB Prostate Cancer
- Stage III Prostate Cancer
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 125 years
- Gender
- Only males
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 bio...
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.
Tracking Information
- NCT #
- NCT01923506
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Sagus Sampath City of Hope Medical Center