Prostate Margin Reduction to Reduce Acute Rectal Toxicity (PROTRACT)

NCT04004858 | Unknown

• 1 other identifier: 043-1819
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

The objectives of this study are:

1. 1.Retrospectively validate a reduced margin schema for intermediate risk prostate hypofractionated VMAT treatments
2. 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

Prostate Cancer

Keywords

Radiation toxicity; Hypofractionation; Margin reduction

Outcome Measures

Primary Outcomes (1)

• Reduced acute rectal toxicity from reduced PTV margin

  Patients planned and treated with reduced PTV margin will have a change of 2 points in Cancer Care Ontario (CCO) Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) bowel symptom scores, demonstrating better toxicity outcomes. This patient reported outcome questionnaire evaluates bowel symptom scores in four aspects: rectal pain or urgency of bowel movement, increased frequency of bowel movements, overall problems with bowel movements, and bloody stools. Each aspect has a score ranging from 0 to 4. The total scores for an individual patient ranges from 0 to 16, with lower score indicating a better outcome.

  6 months

Study Arms (2)

Standard margin

ACTIVE COMPARATOR

Patient cohort planned with the current standard PTV margin

Radiation: External beam radiation therapy

Reduced margin

EXPERIMENTAL

Patient cohort planned with the reduced margin validated from the retrospective study

Radiation: External beam radiation therapy

Interventions

External beam radiation therapy RADIATION

Patient will receive 60Gy in 20 fractions as per standard practice

Reduced margin; Standard margin

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male patient diagnosed with intermediate-risk prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients with intermediate-risk prostate cancer receiving external beam radiotherapy
• Age greater than or equal to 18 years
• Agreeable to proposed follow-up schedule and able to complete quality of life questionnaire as proposed

You may not qualify if:

• Previous radiotherapy to the pelvic region
• Inflammatory bowel disease or chronic colitis.
• Connective tissue disorders such as scleroderma.
• Patients with hip replacements

Sponsors & Collaborators

• Southlake Regional Health Centre: lead
• Sunnybrook Health Sciences Centre: collaborator
• University Health Network, Toronto: collaborator

Study Sites (3)

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P9, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (17)

• National Comprehensive Cancer Network: Prostate cancer, 2016. https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf

  BACKGROUND

• Wortel 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 BACKGROUND

• Dearnaley 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 BACKGROUND

• Alayed 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

  BACKGROUND

• Nijkamp 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 BACKGROUND

• Gill 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 BACKGROUND

• Battista 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.

  PMID: 23978708 BACKGROUND

• Nuver TT, Hoogeman MS, Remeijer P, van Herk M, Lebesque JV. An adaptive off-line procedure for radiotherapy of prostate cancer. Int J Radiat Oncol Biol Phys. 2007 Apr 1;67(5):1559-67. doi: 10.1016/j.ijrobp.2006.12.010. Epub 2007 Feb 15.

  PMID: 17306934 BACKGROUND

• Engels B, Soete G, Gevaert T, Storme G, Michielsen D, De Ridder M. Impact of planning target volume margins and rectal distention on biochemical failure in image-guided radiotherapy of prostate cancer. Radiother Oncol. 2014 Apr;111(1):106-9. doi: 10.1016/j.radonc.2014.02.009. Epub 2014 Mar 13.

  PMID: 24631146 BACKGROUND

• Quon HC et al: PATRIOT trial: randomized phase II study of prostate stereotactic body radiotherapy comparing 11 versus 29 days overall treatment time. J Clin Oncol 33:(S)6-6, 2015.

  BACKGROUND

• Catton CN, Lukka H, Gu CS, Martin JM, Supiot S, Chung PWM, Bauman GS, Bahary JP, Ahmed S, Cheung P, Tai KH, Wu JS, Parliament MB, Tsakiridis T, Corbett TB, Tang C, Dayes IS, Warde P, Craig TK, Julian JA, Levine MN. Randomized Trial of a Hypofractionated Radiation Regimen for the Treatment of Localized Prostate Cancer. J Clin Oncol. 2017 Jun 10;35(17):1884-1890. doi: 10.1200/JCO.2016.71.7397. Epub 2017 Mar 15.

  PMID: 28296582 BACKGROUND

• Dearnaley D, Syndikus I, Mossop H, Khoo V, Birtle A, Bloomfield D, Graham J, Kirkbride P, Logue J, Malik Z, Money-Kyrle J, O'Sullivan JM, Panades M, Parker C, Patterson H, Scrase C, Staffurth J, Stockdale A, Tremlett J, Bidmead M, Mayles H, Naismith O, South C, Gao A, Cruickshank C, Hassan S, Pugh J, Griffin C, Hall E; CHHiP Investigators. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial. Lancet Oncol. 2016 Aug;17(8):1047-1060. doi: 10.1016/S1470-2045(16)30102-4. Epub 2016 Jun 20.

  PMID: 27339115 BACKGROUND

• Chang P, Szymanski KM, Dunn RL, Chipman JJ, Litwin MS, Nguyen PL, Sweeney CJ, Cook R, Wagner AA, DeWolf WC, Bubley GJ, Funches R, Aronovitz JA, Wei JT, Sanda MG. Expanded prostate cancer index composite for clinical practice: development and validation of a practical health related quality of life instrument for use in the routine clinical care of patients with prostate cancer. J Urol. 2011 Sep;186(3):865-72. doi: 10.1016/j.juro.2011.04.085. Epub 2011 Jul 23.

  PMID: 21788038 BACKGROUND

• Howell D et al: Feasibility of implementing EPIC-CP: recommendations to enhance the quality of person-centred clinical care of men with early-stage prostate cancer. Cancer Care Ontario report.

  BACKGROUND

• Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG. Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer. Urology. 2000 Dec 20;56(6):899-905. doi: 10.1016/s0090-4295(00)00858-x.

  PMID: 11113727 BACKGROUND

• Korzeniowski M, Kalyvas M, Mahmud A, Shenfield C, Tong C, Zaza K, Howell D, Brundage M. Piloting prostate cancer patient-reported outcomesin clinical practice. Support Care Cancer. 2016 May;24(5):1983-1990. doi: 10.1007/s00520-015-2949-5. Epub 2015 Oct 24.

  PMID: 26498748 BACKGROUND

• Lee WR et al: RTOG 0415: A phase III randomized study of hypofractionated 3DCRT/IMRT versus conventionally fractionated 3DCRT/IMRT in patients treated for favorable-risk prostate cancer.

  BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Wounds and Injuries

Study Officials

• Beibei Zhang, PhD

  Southlake Regional Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles Cho, MD

CONTACT

905-895-4521; ccho@southlakeregional.org

Beibei Zhang, PhD

CONTACT

905-895-4521; bzhang@southlakeregional.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Physicist

Model Details: The prospective pilot study will consist of two cohorts of patients: one cohort planned with the current standard PTV margin and the second cohort planned with the reduced margin validated from the retrospective study. The first cohort will be recruited while the retrospective study is being carried out and the second cohort will be accrued once the retrospective validation is completed.

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 2, 2019
• Study Start: August 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2021
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)