Stereotactic Body Radiation Therapy to the Prostate Fossa: Phase I Dose Escalation Study

SUMMARY

You have been asked to participate in this research study because you have had a prostatectomy and have either a rise in your PSA test or certain features from your surgery that place you at a higher risk for eventually developing an increase in your PSA.  The purpose of this research study is to determine the highest dose of radiation that can be given to your prostate bed, using a technique known as stereotactic body radiation therapy (SBRT), before significant side effects are seen.  In addition, with longer follow-up, the investigators plan to report on the efficacy of this treatment.  Another purpose is to determine the quality of life of research participants receiving the treatments given on this study.  Your treatment on this study is expected to last one and one-half weeks.  After your treatment on this study is over, your medical condition will continue to be followed on study for 3 years, and indefinitely thereafter as part of standard of care.

Radiation therapy is a standard treatment in men with prostate cancer who have had a prostatectomy in two scenarios: (a) having certain features seen in the surgery specimen that predict for a more aggressive course; or (b) having a rising PSA value in the period following surgery.  The standard length of treatment for radiation to the prostate bed is 7-8 weeks over 35-40 treatment sessions.  Approximately 50 to 60 in 100 men can have their PSA value controlled at 5 years as a result of this treatment.   SBRT is a sophisticated technique to deliver a very potent dose of external beam radiation therapy (EBRT) over a smaller number of treatments, usually 3-5 sessions.  The anticipated rate for PSA control at 5 years with SBRT is expected to be similar to standard EBRT. For men receiving radiation instead of surgery to treat their prostate cancer at the time of original diagnosis, SBRT has been shown to be safe and effective at controlling the cancer with a follow-up of 3 years.  Given these encouraging findings, we are studying the use of SBRT in treatment of the prostate bed after prostatectomy.  The goal is to study a novel radiation delivery approach that has the potential to be equally effective and more convenient than standard EBRT.

COH Protocol Number : 13257

ClinicalTrials.gov Number : NCT01923506

Principal Investigator : Sampath, Sagus M.D.

Sponsor : City of Hope

BRIEF ELIGIBILITY CRITERIA :

Eligible Ages : >=18

Gender : Male

Treatment Intent : Non-Adjuvant treatment

Prior Chemotherapy :

Brain Metastases :

Measurable Disease :