Clinical trial · Interventional
Prostate Margin Reduction to Reduce Acute Rectal Toxicity (PROTRACT)
Reducing Acute Rectal Toxicity for Hypofractionated Prostate Radiotherapy - An Multi-institution Pilot Study of Reduced PTV Margin
NCT04004858CI-TRIAL-00039304PROTRACTunknownN/AClinicalTrials.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 objectives of this study are: 1. Retrospectively validate a reduced margin schema for intermediate risk prostate hypofractionated VMAT treatments 2. Demonstrate in a prospective pilot clinical trial that patients planned and treated with the reduced margin schema will have reduced acute rectal 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 Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| External beam radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard margin
- description
- Patient cohort planned with the current standard PTV margin
- interventionNames
- Radiation: External beam radiation therapy
- type
- EXPERIMENTAL
- label
- Reduced margin
- description
- Patient cohort planned with the reduced margin validated from the retrospective study
- interventionNames
- Radiation: External beam radiation therapy
Primary outcomes (1)
- measure
- Reduced acute rectal toxicity from reduced PTV margin
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male patients with intermediate-risk prostate cancer receiving external beam radiotherapy 2. Age greater than or equal to 18 years 3. Agreeable to proposed follow-up schedule and able to complete quality of life questionnaire as proposed Exclusion Criteria: 1. Previous radiotherapy to the pelvic region 2. Inflammatory bowel disease or chronic colitis. 3. Connective tissue disorders such as scleroderma. 4. Patients with hip replacements
References
Publications (17)
- BACKGROUNDNational Comprehensive Cancer Network: Prostate cancer, 2016. https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf
- BACKGROUNDWortel RC, Incrocci L, Pos FJ, van der Heide UA, Lebesque JV, Aluwini S, Witte MG, Heemsbergen WD. Late Side Effects After Image Guided Intensity Modulated Radiation Therapy Compared to 3D-Conformal Radiation Therapy for Prostate Cancer: Results From 2 Prospective Cohorts. Int J Radiat Oncol Biol Phys. 2016 Jun 1;95(2):680-9. doi: 10.1016/j.ijrobp.2016.01.031. Epub 2016 Jan 22. PMID 27055398
- BACKGROUNDDearnaley DP, Khoo VS, Norman AR, Meyer L, Nahum A, Tait D, Yarnold J, Horwich A. Comparison of radiation side-effects of conformal and conventional radiotherapy in prostate cancer: a randomised trial. Lancet. 1999 Jan 23;353(9149):267-72. doi: 10.1016/S0140-6736(98)05180-0. PMID 9929018
- BACKGROUNDAlayed Y et al: Clinical impact of reducing planning target volume margins during radiation therapy for localized prostate cancer: early outcomes of a 2-stage prospective trial. Int J Radiat Oncol Biol Phys 93:(S)E249, 2015
- BACKGROUNDNijkamp J, Pos FJ, Nuver TT, de Jong R, Remeijer P, Sonke JJ, Lebesque JV. Adaptive radiotherapy for prostate cancer using kilovoltage cone-beam computed tomography: first clinical results. Int J Radiat Oncol Biol Phys. 2008 Jan 1;70(1):75-82. doi: 10.1016/j.ijrobp.2007.05.046. Epub 2007 Sep 17. PMID 17869445
- BACKGROUNDGill SK, Reddy K, Campbell N, Chen C, Pearson D. Determination of optimal PTV margin for patients receiving CBCT-guided prostate IMRT: comparative analysis based on CBCT dose calculation with four different margins. J Appl Clin Med Phys. 2015 Nov 8;16(6):252-262. doi: 10.1120/jacmp.v16i6.5691. PMID 26699581
- BACKGROUNDBattista JJ, Johnson C, Turnbull D, Kempe J, Bzdusek K, Van Dyk J, Bauman G. Dosimetric and radiobiological consequences of computed tomography-guided adaptive strategies for intensity modulated radiation therapy of the prostate. Int J Radiat Oncol Biol Phys. 2013 Dec 1;87(5):874-80. doi: 10.1016/j.ijrobp.2013.07.006. Epub 2013 Aug 24.