NCT01352429

Mild Hypofractionation With Proton Therapy or IMRT for Intermediate-Risk Prostate Cancer

A Phase II Trial of Proton Radiation Therapy or Intensity-Modulated Radiation Therapy Using Mild Hypofractionation for Low-and Intermediate -Risk Adenocarcinoma of the Prostate

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 303 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study to first establish feasibility of the study and then to register the treatment data of adult patients with a diagnosis of intermediate risk of prostate cancer presenting for definitive radiation treatment with either proton radiotherapy or Intensity Modulated Radiation Therapy (IMRT). The investigators propose to employ a hypofractionated strategy with our image guided treatment to further improve cancer control and decrease toxicity.

Detailed description

This study will be done in two phases, first, a feasibility study and then a registration study. In the first, feasibility will be established using the primary objectives set below. The second phase will begin no earlier than 30 days after the last patient in the initial phase has completed treatment and once safety and feasibility has been verified. The secondary objectives will serve as the objectives for the second phase of the study.

Conditions

• Prostate Adenocarcinoma

Interventions

Type	Name	Description
RADIATION	Proton Therapy
RADIATION	IMRT

Timeline

• Start date: 2009-08-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2011-05-11
• Last updated: 2025-07-17

Locations

2 sites across 1 country: United States