Clinical Trials Search
Clinical Trial 18201
Cancer Type: Genitourinary
Study Type: Treatment
Phase of Study: Phase I
- Peter Johnstone
A Phase I Dose Escalation Study of Preoperative Stereotactic Body Radiation Therapy (SBRT) for High Risk Prostate Cancer
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, 6 or 7 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.
The primary objectives are to determine: 1) the safety of preoperative SBRT alone at 21 plus/minus 5 days post-irradiation; and 2) the dose-limiting toxicity and quality of life due to preoperative SBRT followed by robotic-assisted laparoscopic radical prostatectomy at 14 plus/minus 5 days and 28 plus/minus 5 days post-prostatectomy. The secondary objective is to determine whether the radiosensitivity index predicts for positive surgical margins.