Clinical trial · Interventional
Proton Therapy vs. IMRT for Low or Intermediate Risk Prostate Cancer
Prostate Advanced Radiation Technologies Investigating Quality of Life (PARTIQoL): A Phase III Randomized Clinical Trial of Proton Therapy vs IMRT for Low or Intermediate Risk Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
We are studying whether men being treated for prostate cancer have the same amount of side effects from either one of two different external radiation treatments: IMRT or PBT. With IMRT, a number of x-ray beams are used to shape the radiation to the prostate. PBT is another type of external radiation treatment for prostate cancer that is used in a few centers in the United States. Protons are tiny particles with positive charge that can be controlled to travel a certain distance and stop. PBT is precise like IMRT, but it uses proton beams instead of x-ray beams. IMRT and PBT aim to deliver most of the radiation to the prostate cancer while sparing surrounding tissues. Both IMRT and PBT have been used in the treatment of prostate cancer and are thought to be equally effective at curing prostate cancer. However, both treatments have also been shown to cause the potential side effects of radiation, including bowel, urinary and erectile problems. It is possible that side effect rates with PBT will be lower, the same, or even higher than with IMRT, but this has not been studied well to date. Though both of these radiation therapies have been used in the past to treat prostate cancer, there has never been a study that compares the effects of these two therapies to see which one has less side effects. In this research study, we are comparing IMRT to PBT to determine which therapy best minimizes the side effects of treatment.
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 Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensity Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
| Proton Beam Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- PBT
- description
- Proton Beam Therapy
- interventionNames
- Radiation: Proton Beam Therapy
- type
- ACTIVE_COMPARATOR
- label
- IMRT
- description
- Intensity Modulated Radiation Therapy
- interventionNames
- Radiation: Intensity Modulated Radiation Therapy
Primary outcomes (1)
- measure
- Efficacy of PBT vs. IMRT
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with histologically confirmed adenocarcinoma of the prostate based on core-biopsy within 1 year of study entry from TRUS * Clinical stages T1c to T2c * PSA \<20, within 6 months of study entry * Participants who are currently receiving Dutasteride (or have received it within the last 90 days) or Finasteride (or have received it within the last 30 days) must have a PSA of ≤ 10 * Gleason score ≤6, 3 + 4 = 7, or 4 + 3 = 7 * ECOG Performance Status 0-1 as documented within 3 months prior to study entry * Must have complete history and physical examination within 45 days of study entry and digital rectal examination of prostate within 180 days of study entry Exclusion Criteria: * Prior surgery (not including TURP), cryosurgery, radiofrequency ablation, chemotherapy or radiation for PCa * Prior or planned androgen deprivation or bilateral orchiectomy * Distant metastases, or clinically or pathologically involved lymph nodes confirmed by a CT scan within 365 days of study entry * Hip prosthesis, inflammatory bowel disease or connective tissue disorder such as active scleroderma or lupus * Individuals with a history of other malignancies are ineligible unless 1) they have been disease-free for at least 5 years OR 2) are deemed by the investigator to be at low risk for recurrence of that malignancy with no plans for adjuvant systemic chemotherapy and/or radiation therapy and have received overall principal investigator approval. * Individuals who have AIDS (CD4 \< 200 or an AIDS-defining illness) or are HIV positive and not on HAART therapy are ineligible. * Major medical or psychiatric illness * Individuals with any of the following conditions are excluded from this study: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months. * Transmural myocardial infarction within the last 6 months. * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration. * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * History of Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects within the last 12 months
References
Publications (1)
- DERIVEDLiu Y, Patel SA, Jani AB, Gillespie TW, Patel PR, Godette KD, Hershatter BW, Shelton JW, McDonald MW. Overall Survival After Treatment of Localized Prostate Cancer With Proton Beam Therapy, External-Beam Photon Therapy, or Brachytherapy. Clin Genitourin Cancer. 2021 Jun;19(3):255-266.e7. doi: 10.1016/j.clgc.2020.08.009. Epub 2020 Aug 28. PMID 32972877