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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Adenocarcinoma
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Enrollment
- 303
- Locations
- 2
- Primary Endpoint
- Acute Toxicity
- Status
- Active, not recruiting
- Last Updated
- 9 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Acute Toxicity
Time Frame: Within 60 days of completion of radiotherapy
Any grade 2 or higher GI or GU toxicity, other than GI or GU toxicity or any grade 3 or higher toxicity, other than GI or GU. In the feasibility phase of this trial, the observation window for acute toxicty is extended to 60 days from completion of radiotherapy, as a feasibility precaution.
Number of Participants with Adverse Events
Time Frame: Within 10 days
Unable to tolerate 10% of treatments using proton radiotherapy. Unable to complete all treatments. Cannot be given treatment because anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised.
Secondary Outcomes
- Biochemical/clinicalprogression-free survival(5 years)
- Late toxicity(open-ended)