NCT02572284

Dose Escalation Study of Preoperative SBRT for High Risk Prostate Cancer

A Phase I Dose Escalation Study of Preoperative Stereotactic Body Radiation Therapy (SBRT) for High Risk Prostate Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given before prostatectomy. Depending when participants enter the study, they will be treated with either 5 or 6 gray (Gy) per day of radiation. A Gy is a measure of radiation dose. The standard dose is 10Gy per day when SBRT is the only treatment to the prostate and no surgery is planned. The researchers want to see which dose of radiation will work best with the least amount of side effects. About 4-6 weeks after SBRT, participants will have a prostatectomy.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiation Therapy (SBRT)	The first group of patients to enter the study will receive 5 Gy of SBRT per day for 5 days, the second group will receive 6 Gy per day for 5 days. Each treatment will take about 3 minutes and be given as an outpatient at Moffitt Cancer Center.
PROCEDURE	Prostatectomy	About 4-6 weeks after SBRT, participants will have a prostatectomy.
OTHER	Quality of Life Questionnaires	Patient assessed health-related quality of life (HRQOL). Quality of Life (QOL) will be assessed using Prostate Symptom Score (IPSS), rectal assessment scale (RAS), sexual health inventory for men (SHIM), and Expanded Prostate Cancer Index Composite (EPIC) patient questionnaires: administered prior to SBRT, and at 2 weeks, 4 weeks, 2 months and then every 3 months up to 18 months post-prostatectomy.

Timeline

• Start date: 2016-01-27
• Primary completion: 2018-07-05
• Completion: 2019-10-23
• First posted: 2015-10-08
• Last updated: 2023-01-19

Locations

1 site across 1 country: United States