NCT01352429Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 22 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 303 (actual)
- First submitted
- 5 May 2011
- Start date
- Aug 2009
- Primary completion date
- Dec 2026
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Diseases
- Prostate cancer
- NCT number
- NCT01352429
What you commit to
- Study type: Observational
- Participants enrolled: 303
- From Aug 2009 to the primary completion date, Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.)
- Previous prostate cancer surgery to include: prostatectomy, hyperthermia, and cryosurgery.
- Previous pelvic radiation for prostate cancer.
- Prior systemic chemotherapy for prostate cancer.
Other illness
- Active rectal diverticulitis, Crohn's disease, or ulcerative colitis.
- History of proximal urethral stricture requiring dilatation.
Other
- Clinical stages T3 or greater (AJCC Criteria 6th Ed).
- PSA of 20 ng/ml or greater.
- Gleason score 8 or higher.
- Evidence of lymph node involvement.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Walter Reed National Military Medical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| Abramson Cancer Center of the University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.