SBRT for Prostate Cancer
(PREPARE SBRT Trial)

Recruiting in Palo Alto (17 mi)

Overseen bySilvia C. Formenti, M.D.

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Weill Medical College of Cornell University

No Placebo Group

Trial Summary

What is the purpose of this trial?

Men with prostate cancer with Gleason Score of 8 or greater or clinical/radiographic evidence of T3 disease will be considered for this trial.

Research Team

Silvia C. Formenti, M.D.

Principal Investigator

Weill Cornell Medicine - New York Presbyterian Hospital

Eligibility Criteria

The PREPARE SBRT trial is for men over 18 with high-risk prostate cancer, confirmed by a Gleason Score of 8+ or evidence of advanced disease (T3). Participants must be fit for surgery, have no prior pelvic radiotherapy, and not currently treated for inflammatory bowel disease. They need to have clear bone scans and MRI/CT scans without significant nodal involvement.

Inclusion Criteria

Patient can undergo an MRI.

I am mostly able to care for myself and carry out daily activities.

I am a man over 18 with confirmed prostate cancer.

See 4 more

Exclusion Criteria

I am currently being treated for inflammatory bowel disease.

I have had radiation therapy to my pelvic area before.

I do not want to have surgery to remove my prostate.

Treatment Details

Interventions

Dose escalation (Radiation Therapy)

Trial OverviewThis study tests the effects of increasing doses of stereotactic body radiotherapy (SBRT) before prostate removal surgery in men with aggressive prostate cancer. The goal is to see if higher radiation doses can better control the cancer when given before surgery.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

This is a modified dose escalation and de-escalation study with an expansion of 3 or 6 pts to allow the recommended phase II dose (RP2D) be examined in a total of 9 pts. The dose limiting toxicity (DLT) is defined as Grade 3 or higher toxicity related to preoperative radiotherapy according to the Clavien-Dindo Classification. 3 radiation dose levels, 5 Gy, 6 Gy and 6.5Gy are considered. At the start of each dose level, 3 pts will be enrolled and treated for five days. If none of the 3 pts develop the DLT, the testing dose will escalate to the next level. If 1 of the 3 pts develops the DLT, the current dose will be tested in an additional 3 pts. If no additional pts develop the DLT, the dose will escalate.