Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
88

Summary

Conditions
Adenocarcinoma of the Prostate
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients will be assigned to treatment group according to their lymph node risk or seminal vesicle invasion. 2 treatment groups: HR-A: Patients with <25% risk of positive pelvic nodes, without posterior extracapsular extension and negative for seminal vesicle invasion on exam pretreatment diagnostic MRI. HR-B: Patient with ? 25% risk of positive pelvic nodes or with seminal vesicle invasion, without posterior extracapsular extension. Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 100 years
Gender
Only males

Description

Prostate cancer is the most common noncutaneous cancer among men in the United States. The purpose of this research study is to determine if dose-escalated proton radiation therapy is a good way to treat high-risk prostate cancer. Proton therapy (PT) is a type of ionizing radiation therapy that redu...

Prostate cancer is the most common noncutaneous cancer among men in the United States. The purpose of this research study is to determine if dose-escalated proton radiation therapy is a good way to treat high-risk prostate cancer. Proton therapy (PT) is a type of ionizing radiation therapy that reduces the dose of excess radiation delivered to normal tissues. By escalating the radiation dose just to the area of the known tumor within the prostate, one could potentially reduce the amount of excess radiation delivered to surrounding organs.This reduction in dose would improve the therapeutic ratio by improving disease control while minimizing the risk for additional toxicity. In an effort to take advantage of dose escalation's potential for improving disease control but also to limit toxicity, the use of advanced imaging to identify prostate cancer and provide a focal radiation boost to the area have proven to be useful. Recent advances in MRI have made it the most promising technique in identifying and targeting IPTs, improving both cancer control rates and decreasing toxicity. The study features hypofractionation and a simultaneous integrated boost to the MRI identified intraprostatic tumor (IPT) as a method of dose-escalating radiation therapy. The study will include patients with high-risk prostate cancer who are at the highest risk for recurrence. Radiation therapy will be delivered over the course of 8-9 weeks. Additionally, androgen deprivation therapy (ADT) will be started 8-10 weeks prior to starting radiation and continued for a total of 18 months.

Tracking Information

NCT #
NCT03624660
Collaborators
Not Provided
Investigators
Principal Investigator: Curtis M Bryant, MD, MPH University of Florida Health Proton Therapy Institute