Recruitment

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