Clinical trial · Interventional
Proton Boost in Prostate Cancer
Assessing the Effectiveness of Photon Therapy With a Proton Therapy Boost in the Treatment of Prostate Cancer as Compared to Photon Therapy Alone
- 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 study uses photon radiation with a proton boost to treat prostate cancer. The purpose of this study is to determine if proton therapy as a boost following photon intensity modulated radiation therapy (IMRT) produces decreased toxicity as compared to conventional photon IMRT alone in the treatment of prostate cancer. Our secondary objective is to determine the effectiveness of this treatment regimen. Effectiveness will be determined by length of time to progression or recurrence of disease and overall survival. Patients on this study will be treated with a course of photon radiation therapy followed by a boost course of proton radiation.
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 |
|---|---|---|---|
| Cancer of the Prostate | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton Boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prospective Treatment Group
- description
- Proton Boost
- interventionNames
- Radiation: Proton Boost
- type
- NO_INTERVENTION
- label
- Retrospective Comparison Group
- description
- Retrospective patients previously treated with standard of care photon therapy. There is no patient interaction with this group. Data collection from medical records only.
Primary outcomes (6)
- measure
- Hematuria - Change from baseline
- timeFrame
- Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
- description
- Common Terminology Criteria for Adverse Events - Hematuria Scale - 1(least severe) - 5 (most severe)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥18 years of age * Diagnosis of low risk prostate cancer (T1c-T2a, Gleason 6, Prostate Specific Antigen (PSA) \<10) -OR- * Diagnosis of intermediate risk prostate cancer (T1c-T2c, Gleason 7 and/or PSA 10- 20) * Life expectancy \>10 yrs * Physically and mentally capable of signing the consent form of their own volition Exclusion Criteria: * \< 18 years of age * Diagnosis of high risk prostate cancer (T3 or higher, Gleason \>7 and/or PSA \>20) * Current or historical use of androgen deprivation therapy * Nodal positivity * Previous cancer excluding non-melanoma skin cancer * History of prostatectomy * History of brachytherapy for prostate cancer * Life expectancy \<10 yrs * Physically or mentally incapable of signing the consent form of their own volition
References
Publications (11)
- BACKGROUNDBoccon-Gibod LM, Dumonceau O, Toublanc M, Ravery V, Boccon-Gibod LA. Micro-focal prostate cancer: a comparison of biopsy and radical prostatectomy specimen features. Eur Urol. 2005 Dec;48(6):895-9. doi: 10.1016/j.eururo.2005.04.033. PMID 16125298
- BACKGROUNDGregori A, Vieweg J, Dahm P, Paulson DF. Comparison of ultrasound-guided biopsies and prostatectomy specimens: predictive accuracy of Gleason score and tumor site. Urol Int. 2001;66(2):66-71. doi: 10.1159/000056573. PMID 11223746
- BACKGROUNDScales CD, Amling CL, Kane CJ, et al. Can unilateral Prostate Cancer be Reliably Predicted Based Upon Biopsy Features? J Urol. 2006; 175:373.
- BACKGROUNDSchulte RT, Wood DP, Daignault S, Shah RB, Wei JT. Utility of extended pattern prostate biopsies for tumor localization: pathologic correlations after radical prostatectomy. Cancer. 2008 Oct 1;113(7):1559-65. doi: 10.1002/cncr.23781. PMID 18726951
- BACKGROUNDArrayeh E, Westphalen AC, Kurhanewicz J, Roach M 3rd, Jung AJ, Carroll PR, Coakley FV. Does local recurrence of prostate cancer after radiation therapy occur at the site of primary tumor? Results of a longitudinal MRI and MRSI study. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):e787-93. doi: 10.1016/j.ijrobp.2011.11.030. Epub 2012 Feb 11. PMID 22331003
- BACKGROUNDPollack A, Zagars GK, Starkschall G, Antolak JA, Lee JJ, Huang E, von Eschenbach AC, Kuban DA, Rosen I. Prostate cancer radiation dose response: results of the M. D. Anderson phase III randomized trial. Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1097-105. doi: 10.1016/s0360-3016(02)02829-8. PMID 12128107
- BACKGROUNDPeeters ST, Heemsbergen WD, Koper PC, van Putten WL, Slot A, Dielwart MF, Bonfrer JM, Incrocci L, Lebesque JV. Dose-response in radiotherapy for localized prostate cancer: results of the Dutch multicenter randomized phase III trial comparing 68 Gy of radiotherapy with 78 Gy. J Clin Oncol. 2006 May 1;24(13):1990-6. doi: 10.1200/JCO.2005.05.2530.