Clinical trial · Interventional
Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer
Phase I-II Trial of Hypofractionated Conformal Proton Beam Radiation Therapy for Favorable-risk Prostate Cancer
NCT00831623CI-TRIAL-00064650completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine hypofractionated conformal proton beam radiation therapy of prostate cancer can achieve similar treatment benefits as our current institutional standard with conventional fractionation.
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 |
|---|---|---|---|
| Proton | Radiation | — | UNRESOLVED |
| Proton Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Proton radiation therapy
- description
- Single arm
- interventionNames
- Radiation: Proton Radiation
- Radiation: Proton
Primary outcomes (1)
- measure
- Number of Participants With Late Treatment-Related Toxicity Greater Than or Equal to Grade 3, CTCAE Version 4.0
- timeFrame
- Every 6 months after completing treatment through the duration of the trial with a minimum of 2 years follow-up and an average of 5 years
- description
- To determine if late CTCAE version 4.0 Grade 3 treatment-related morbidity, which is no worse than that engendered by our current institutional standard with conventional fractionation, can be maintained in a hypofractionated schedule.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma within 180 days of registration * History \& Physical Exam, including digital rectal exam (DRE), within 8 wks prior to registration * Histologic evaluation of prostate biopsies at LLUMC, with Gleason score assignment * Clinical stage, Tumor Stage (T1-T2C) * Prostatic Specific Antigen (PSA) less than 10 ng.ml within 180 days prior to registration Exclusion Criteria: * Prior or concurrent invasive malignancy * Evidence of distant metastasis
References
Publications (13)
- BACKGROUNDZietman AL, DeSilvio ML, Slater JD, Rossi CJ Jr, Miller DW, Adams JA, Shipley WU. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA. 2005 Sep 14;294(10):1233-9. doi: 10.1001/jama.294.10.1233. PMID 16160131
- BACKGROUNDRossi CJ Jr, Slater JD, Yonemoto LT, Jabola BR, Bush DA, Levy RP, Grove R, Slater JM. Influence of patient age on biochemical freedom from disease in patients undergoing conformal proton radiotherapy of organ-confined prostate cancer. Urology. 2004 Oct;64(4):729-32. doi: 10.1016/j.urology.2004.04.043. PMID 15491710
- BACKGROUNDSlater JD, Rossi CJ Jr, Yonemoto LT, Bush DA, Jabola BR, Levy RP, Grove RI, Preston W, Slater JM. Proton therapy for prostate cancer: the initial Loma Linda University experience. Int J Radiat Oncol Biol Phys. 2004 Jun 1;59(2):348-52. doi: 10.1016/j.ijrobp.2003.10.011. PMID 15145147
- BACKGROUNDSlater JM, Bush DA, Grove R, Slater JD. The prognostic value of percentage of positive biopsy cores, percentage of cancer volume, and maximum involvement of biopsy cores in prostate cancer patients receiving proton and photon beam therapy. Technol Cancer Res Treat. 2014 Jun;13(3):227-31. doi: 10.7785/tcrtexpress.2013.600271. Epub 2013 Sep 20. PMID 24066950
- BACKGROUNDCoen JJ, Bae K, Zietman AL, Patel B, Shipley WU, Slater JD, Rossi CJ. Acute and late toxicity after dose escalation to 82 GyE using conformal proton radiation for localized prostate cancer: initial report of American College of Radiology Phase II study 03-12. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):1005-9. doi: 10.1016/j.ijrobp.2010.06.047. Epub 2010 Oct 6. PMID 20932675
- BACKGROUNDTalcott JA, Rossi C, Shipley WU, Clark JA, Slater JD, Niemierko A, Zietman AL. Patient-reported long-term outcomes after conventional and high-dose combined proton and photon radiation for early prostate cancer. JAMA. 2010 Mar 17;303(11):1046-53. doi: 10.1001/jama.2010.287.