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

Running, not enrolling

Conditions studied: Prostate Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT01352429

Run by

Abramson Cancer Center at Penn Medicine

People needed

303

Starts

2009-08-01

Expected to finish

2026-12-01

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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