A Single Arm Phase II Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Primary Endpoint
- Measure of PSA (Prostate Specific Antigen)
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Measure of PSA (Prostate Specific Antigen)
Time Frame: 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
Time Frame: Up to 12 months
Number of symptomatic anastomotic events related to pre-operative SBRT.
Secondary Outcomes
- Mean Catheterization Time(Up to 4 weeks post surgery)
- Mean Hospital Stay(Up to 2 week post surgery)
- Quality of Life assessment(Baseline, at 2 weeks, 4 weeks, 2 months and every 3 months up to 12 months post surgery)