Single Arm Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer

Not Applicable

Withdrawn

• Conditions: Prostate Cancer
• Interventions: Device: Stereotactic Body Radiation Therapy (SBRT)

• Registration Number: NCT03748719
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

This study involves Stereotactic Body Radiation Therapy (SBRT) followed by prostatectomy (removal of the prostate). SBRT is a relatively new radiation technique in which a few doses of radiation are delivered to small, well-defined tumors. It has been used effectively in other cancers like lung and liver. The radiation will be given for only 5 days.

The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given before prostatectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-19
• Study First Submitted: 2018-11-19
• Study First Submitted QC: 2018-11-19
• Study First Posted: 2018-11-21
• Primary Completion: 2019-10-15
• Study Completion: 2019-12-04
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-22
• Last Update Posted: 2020-05-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stereotactic Body Radiation Therapy, followed by Prostatectomy	Stereotactic Body Radiation Therapy (SBRT)	Patients will receive 6 Gy per day of Stereotactic Body Radiation Therapy (SBRT) per day for 5 days, followed by prostatectomy in 3 weeks.

Primary Outcome Measures

Name	Time	Method
Measure of PSA (Prostate Specific Antigen)	Up to 12 months	Measure of PSA through treatment. PSA is expected to be undetectable (\<0.2 mg/ml) after prostatectomy and radiation therapy.
Number of symptomatic adverse anastomotic events	Up to 12 months	Number of symptomatic anastomotic events related to pre-operative SBRT.

Secondary Outcome Measures

Name	Time	Method
Mean Catheterization Time	Up to 4 weeks post surgery	Average time of catheterization following prostatectomy
Mean Hospital Stay	Up to 2 week post surgery	Average time of hospitalization after prostatectomy
Quality of Life assessment	Baseline, at 2 weeks, 4 weeks, 2 months and every 3 months up to 12 months post surgery	Quality of Life will be assessed using 2 questionnaires: International Prostate Symptom Score (IPSS) and Sexual Health Inventory for Men (SHIM). The IPSS is an eight question questionnaire of symptoms ranging from 0 "not at all" to 5 "always". The SHIM is a five question questionnaire ranging from 1 "almost never or never" to 5 "almost always or always" to determine erectile dysfunction.