Mild Hypofractionation With Proton Therapy or Intensity Modulated Radiation Therapy (IMRT) for Intermediate-Risk Prostate Cancer

Launched by ABRAMSON CANCER CENTER AT PENN MEDICINE · May 10, 2011

Keywords

ClinConnect Summary

This clinical trial is looking at two types of radiation therapy—proton therapy and Intensity Modulated Radiation Therapy (IMRT)—to treat men with intermediate-risk prostate cancer. The goal is to see if using a method called hypofractionation, which delivers radiation in fewer, larger doses, can improve cancer control while reducing side effects. The trial is currently active but not recruiting new participants.

To be eligible for this study, participants must be adult males diagnosed with prostate cancer within the last year, have specific cancer stages and scores, and have a prostate-specific antigen (PSA) level below 20. Participants will receive either of the two radiation treatments and will be closely monitored throughout the process. It's important to know that certain health conditions and previous treatments can disqualify potential participants from the trial. Overall, this study aims to find a more effective and safer way to treat prostate cancer.

Gender

MALE

Eligibility criteria

• • 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.