Dose Escalation Study of Preoperative SBRT for High Risk Prostate Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

January 27, 2016

Primary Completion Date

July 5, 2018

Study Completion Date

October 23, 2019

Conditions
Prostate Cancer
Interventions
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.

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

All Listed Sponsors
lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER

NCT02572284 - Dose Escalation Study of Preoperative SBRT for High Risk Prostate Cancer | Biotech Hunter | Biotech Hunter