Single Arm Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer
Overview
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.
Full Title of Study: “A Single Arm Phase II Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: October 15, 2019
Interventions
- Device: Stereotactic Body Radiation Therapy (SBRT)
- SBRT treatment
Arms, Groups and Cohorts
- Experimental: Stereotactic Body Radiation Therapy, followed by Prostatectomy
- Patients will receive 6 Gy per day of Stereotactic Body Radiation Therapy (SBRT) per day for 5 days, followed by prostatectomy in 3 weeks.
Clinical Trial Outcome Measures
Primary Measures
- 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 Measures
- Mean Catheterization Time
- Time Frame: Up to 4 weeks post surgery
- Average time of catheterization following prostatectomy
- Mean Hospital Stay
- Time Frame: Up to 2 week post surgery
- Average time of hospitalization after prostatectomy
- Quality of Life assessment
- Time Frame: 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.
Participating in This Clinical Trial
Gender Eligibility: Male
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Peter Johnstone, MD, Principal Investigator, H. Lee Moffitt Cancer Center and Research Institute
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