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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Adenocarcinoma
• Intervention / Treatment: Radiation: Proton Therapy; Radiation: IMRT

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.

• Study Type: Observational
• Enrollment (Actual): 303

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Military Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with non-metastatic adenocarcinoma of the prostate, presenting for definitive proton or photon radiotherapy of the prostate.

Description

Inclusion Criteria

• Histologically confirmed prostate adenocarcinoma within 365 days of registration.
• Clinical stages T1a-T2c N0 M0 (AJCC Criteria 6th Ed). For any suspicious pelvic lymph node > 1.5cm (as exhibited on pelvic imaging), biopsy of the lymph node is suggested.
• Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range 2-7. Biopsy with > 6 cores is strongly recommended. (The highest Gleason Score in any core reported on the pathology report will be used for determining inclusion.)
• PSA values <20 ng/ml within 90 days prior to registration, and done either prior to prostate biopsy, or at least 21 days after prostate biopsy.
• Zubrod (ECOG) status 0-1 documented within 90 days of registration.
• Androgen deprivation is at the discretion of the treating radiation oncologist.
• Subjects must give IRB-approved study-specific informed consent. Subjects must complete all required tests within the specified time frames.
• Subjects must be at least 18 years old.
• Members of all races and ethnic groups are eligible for this trial.

Exclusion Criteria

• Clinical stages T3 or greater (AJCC Criteria 6th Ed).
• PSA of 20 ng/ml or greater.
• Gleason score 8 or higher.
• Evidence of distant metastasis. (Determined by CT scan, MRI, and/or bone scan prior to the simulation appointment; imaging results from UPHS will supercede results from similar scans from an outside facility.)
• Evidence of lymph node involvement.
• Previous prostate cancer surgery to include: prostatectomy, hyperthermia, and cryosurgery.
• Previous pelvic radiation for prostate cancer.
• Active rectal diverticulitis, Crohn's disease, or ulcerative colitis.
• Prior systemic chemotherapy for prostate cancer.
• History of proximal urethral stricture requiring dilatation.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Phase 1 Feasibility	Radiation: Proton Therapy; Radiation: IMRT
Phase 2 Registration	Radiation: Proton Therapy; Radiation: IMRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events	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.	Within 10 days
Acute Toxicity	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.	Within 60 days of completion of radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late toxicity	Any grade 2 or higher GI or GU toxicity or any grade 3 or higher toxicity, other than GI or GU which occurs beyond 60 days from completion of radiotherapy. Late toxicities will be graded according to the RTOG/EORTC late morbidity scoring system.	open-ended
Biochemical/clinicalprogression-free survival	The time from start of radiotherapy to either documented increase in PSA or clinical progression of disease (based on CT, MRI, or bone scan), death due to any cause or last patient contact alive.	5 years

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Investigators: Principal Investigator: Neha Vapiwala, MD, Abramson Cancer Center at Penn Medicine

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 5, 2011
• First Submitted That Met QC Criteria: May 10, 2011
• First Posted (Estimated): May 11, 2011

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: adult; histologically confirmed
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma; Therapeutics; Radiotherapy; Heavy Ion Radiotherapy; Proton Therapy
• Other Study ID Numbers: UPCC 18809

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No