Prostate CancerPROTRACTNCT04004858
Prostate Margin Reduction to Reduce Acute Rectal Toxicity (PROTRACT)
A study testing External beam radiation therapy in people with Prostate Cancer, run by Southlake Health at 3 sites in Canada.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- External beam radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Aug 2019to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous radiotherapy to the pelvic region
- Inflammatory bowel disease or chronic colitis.
- Connective tissue disorders such as scleroderma.
- Patients with hip replacements
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
About this study
Official title: Reducing Acute Rectal Toxicity for Hypofractionated Prostate Radiotherapy - An Multi-institution Pilot Study of Reduced PTV Margin
The objectives of this study are:
- Retrospectively validate a reduced margin schema for intermediate risk prostate hypofractionated VMAT treatments
- Demonstrate in a prospective pilot clinical trial that patients planned and treated with the reduced margin schema will have reduced acute rectal toxicity
Read the detailed description
Hypofractionated radiotherapy is being adopted as standard practice for intermediate risk prostate cancer patients. The objective of this project is to retrospectively validate whether reducing the Planning Target Volume (PTV), a margin placed around the prostate to account for movement and variability in patient placement, will have reduced acute rectal toxicity. The project will focus on patients with intermediate risk prostate cancer treated with hypofractionated Volumetric Modulated Arc Therapy (VMAT) from multiple institutions. The investigators intend to prospectively demonstrate that patients planned and treated with the reduced margin, along with using advanced image-guidance and consistent bladder and rectum preparation will have reduced acute rectal toxicity.
The project consists of two phases: phase one is a retrospective planning study and phase two is a prospective pilot clinical trial.
Phase one aims to validate the benefits of the proposed decrease in PTV margin by assessing whether the investigators can continue to deliver the intended radiation dose to the prostate while further sparing the rectum. This will be accomplished by evaluating the daily delivered dose on Cone-Beam Computed Tomography (CBCT), a daily scan performed during treatment that determines the location of the prostate and rectum. Using these CBCT scans, the investigators can reconstruct the radiation dose delivered to any organs of interest which was affected by their relative positions each day. There are two parts in this phase one retrospective planning study. Part one will focus on 30 intermediate risk prostate cancer cases already treated with hypofractionation (60 Gy in 20 fractions) using the standard PTV margins from all three participating institutions. All 30 cases will then be re-planned using the reduced PTV margin and dose reconstruction will be performed on daily CBCT to confirm adequate target coverage of the prostate. Part two aims to demonstrate that the reduced PTV margin can help enable hypofractionation. Thirty cases that were originally intended to receive a hypofractionated regimen of 60 Gy in 20 fractions but had to either switch to a standard fractionation treatment of 78 Gy in 39 fractions (a regimen used when 60Gy in 20 fractions is not achievable), or where there had to be compromised target coverage of the prostate, due to Organs at Risk (OAR) receiving unacceptable doses of radiation, will be selected. These cases will be re-planned with the validated smaller PTV margin to illustrate that they would now be eligible to receive hypofractionation due to the reduced dose to OARs.
Phase two aims to demonstrate that patients treated with the reduced PTV margin will have reduced acute rectal toxicity as evaluated by the Cancer Care Ontario (CCO) Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) Quality of Life (QOL) questionnaire. Two groups of patients will be accrued: one group of 25 patients will be planned and treated with the current standard PTV margin as the control group, while the second group of 25 patients will be planned and treated with the reduced PTV margin validated from the phase one retrospective study. A comparison of rectal toxicity scores between these two groups will then be carried out using the EPIC-CP questionnaire.
- Conditions
- Prostate Cancer
- Being tested
- External beam radiation therapy
- Keywords
- Radiation toxicity, Hypofractionation, Margin reduction
- Medical subject headings
- Prostatic Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External beam radiation therapyRadiation
Patient will receive 60Gy in 20 fractions as per standard practice
| Study group | Role | What they receive |
|---|---|---|
| Standard margin | Active comparator | Patient cohort planned with the current standard PTV margin Receives: Radiation: External beam radiation therapy |
| Reduced margin | Experimental | Patient cohort planned with the reduced margin validated from the retrospective study Receives: Radiation: External beam radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start1 Aug 2019 (estimated)
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southlake Health
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, University Health Network, Toronto
- Responsible party
- Principal investigator, Beibei Zhang, Southlake Health
- Investigators
- Beibei Zhang, PhD, Principal investigator, Southlake Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004858
- Sponsor's protocol ID
- 043-1819
- Acronym
- PROTRACT
- Status last verified
- Jul 2019
- First submitted
- 28 Jun 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
National Comprehensive Cancer Network: Prostate cancer, 2016. https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf
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.
PubMed 27055398Dearnaley 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.
PubMed 9929018Alayed 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
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.
PubMed 17869445Gill 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.
PubMed 26699581Battista 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.
PubMed 23978708Nuver 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.
PubMed 17306934Engels 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.
PubMed 24631146Quon 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.
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.
PubMed 28296582Dearnaley 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.
PubMed 27339115Chang 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.
PubMed 21788038Howell 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.
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.
PubMed 11113727
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Acute Rectal Toxicity for Hypofractionated Prostate Radiotherapy - An Multi-institution Pilot Study of Reduced PTV Margin
- ClinicalTrials.gov ID
- NCT04004858
- Acronym / sponsor ID
- PROTRACT / 043-1819
- Conditions
- Prostate Cancer
- Keywords
- Radiation toxicity, Hypofractionation, Margin reduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Southlake HealthUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, University Health Network, Toronto
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are:
- Retrospectively validate a reduced margin schema for intermediate risk prostate hypofractionated VMAT treatments
- Demonstrate in a prospective pilot clinical trial that patients planned and treated with the reduced margin schema will have reduced acute rectal toxicity
Detailed description
Hypofractionated radiotherapy is being adopted as standard practice for intermediate risk prostate cancer patients. The objective of this project is to retrospectively validate whether reducing the Planning Target Volume (PTV), a margin placed around the prostate to account for movement and variability in patient placement, will have reduced acute rectal toxicity. The project will focus on patients with intermediate risk prostate cancer treated with hypofractionated Volumetric Modulated Arc Therapy (VMAT) from multiple institutions. The investigators intend to prospectively demonstrate that patients planned and treated with the reduced margin, along with using advanced image-guidance and consistent bladder and rectum preparation will have reduced acute rectal toxicity.
The project consists of two phases: phase one is a retrospective planning study and phase two is a prospective pilot clinical trial.
Phase one aims to validate the benefits of the proposed decrease in PTV margin by assessing whether the investigators can continue to deliver the intended radiation dose to the prostate while further sparing the rectum. This will be accomplished by evaluating the daily delivered dose on Cone-Beam Computed Tomography (CBCT), a daily scan performed during treatment that determines the location of the prostate and rectum. Using these CBCT scans, the investigators can reconstruct the radiation dose delivered to any organs of interest which was affected by their relative positions each day. There are two parts in this phase one retrospective planning study. Part one will focus on 30 intermediate risk prostate cancer cases already treated with hypofractionation (60 Gy in 20 fractions) using the standard PTV margins from all three participating institutions. All 30 cases will then be re-planned using the reduced PTV margin and dose reconstruction will be performed on daily CBCT to confirm adequate target coverage of the prostate. Part two aims to demonstrate that the reduced PTV margin can help enable hypofractionation. Thirty cases that were originally intended to receive a hypofractionated regimen of 60 Gy in 20 fractions but had to either switch to a standard fractionation treatment of 78 Gy in 39 fractions (a regimen used when 60Gy in 20 fractions is not achievable), or where there had to be compromised target coverage of the prostate, due to Organs at Risk (OAR) receiving unacceptable doses of radiation, will be selected. These cases will be re-planned with the validated smaller PTV margin to illustrate that they would now be eligible to receive hypofractionation due to the reduced dose to OARs.
Phase two aims to demonstrate that patients treated with the reduced PTV margin will have reduced acute rectal toxicity as evaluated by the Cancer Care Ontario (CCO) Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) Quality of Life (QOL) questionnaire. Two groups of patients will be accrued: one group of 25 patients will be planned and treated with the current standard PTV margin as the control group, while the second group of 25 patients will be planned and treated with the reduced PTV margin validated from the phase one retrospective study. A comparison of rectal toxicity scores between these two groups will then be carried out using the EPIC-CP questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard margin | Active comparator | Radiation: External beam radiation therapyPatient cohort planned with the current standard PTV margin |
| Reduced margin | Experimental | Radiation: External beam radiation therapyPatient cohort planned with the reduced margin validated from the retrospective study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Previous radiotherapy to the pelvic region
- Inflammatory bowel disease or chronic colitis.
- Connective tissue disorders such as scleroderma.
- Patients with hip replacements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External beam radiation therapyPatient will receive 60Gy in 20 fractions as per standard practice | Radiation | Reduced margin, Standard margin |
Primary outcome
Reduced acute rectal toxicity from reduced PTV margin
Time frame: 6 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- BackgroundNational Comprehensive Cancer Network: Prostate cancer, 2016. https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf
- Background: PubMed 27055398Wortel 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.
- Background: PubMed 9929018Dearnaley 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.
- 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
- Background: PubMed 17869445Nijkamp 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.
- Background: PubMed 26699581Gill 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.
- Background: PubMed 23978708Battista 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.
- Background: PubMed 17306934Nuver 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.
- Background: PubMed 24631146Engels 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.
- BackgroundQuon 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: PubMed 28296582Catton 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.
- Background: PubMed 27339115Dearnaley 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.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beibei Zhang, PhD principal investigator
Southlake Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External beam radiation therapy in people with Prostate Cancer, run by Southlake Health at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charles Cho, MD (905-895-4521 ext. 6539, ccho@southlakeregional.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced acute rectal toxicity from reduced PTV margin (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04004858, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.