Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMRT | Radiation | — | UNRESOLVED |
| Proton Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Phase 1 Feasibility
- interventionNames
- Radiation: Proton Therapy
- Radiation: IMRT
- label
- Phase 2 Registration
- interventionNames
- Radiation: Proton Therapy
- Radiation: IMRT
Primary outcomes (2)
- measure
- Number of Participants with Adverse Events
- timeFrame
- Within 10 days
- description
- 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.
- measure
- Acute Toxicity
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available