Prostate CancerDESTINATION-MRNCT06177093
Pilot Study of Dose Escalation in Prostate Radiotherapy Using the MR-Linac (DESTINATION-MRL)
A study testing MR Linac delivered Radiotherapy in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
This study is a single centre feasibility trial. The trial will recruit men with intermediate risk localised prostate cancer who will all receive targeted dose (escalated/de-escalated dose directed by MRI) 5 fraction SBRT to the prostate. Trial Objectives are: 1. 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?
- MR Linac delivered Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 11 Dec 2023to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Men aged ≥18 years
- Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy
- Gleason score 3+3, 3+4 or 4+3 (Grade groups 1, 2 or 3)
- MRI stage T2 or less (as staged by AJCC TNM 2018)
- MRI-visible tumour(s) of PIRADS v2 grade 3 or higher on T2 and diffusion-weighted imaging and/or dynamic contrast-enhanced imaging (multiparametric MRI or mpMRI) with concordant pathology
- Tumour nodule visible on MRI occupying <50% of prostate on any axial slice and <50% prostate volume
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- PSA <20 ng/ml prior to starting ADT (if applicable)
- Short course (< 6 months) concurrent androgen deprivation therapy (antiandrogens or LHRH analogues) allowed though not mandated as per the discretion of the treating physician.
- WHO Performance status 0-2
- Ability of the participant understand and the willingness to sign a written informed consent form.
- Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study.
Who cannot join
- Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)
- IPSS 19 or higher
- High grade disease (GG3) occult to MRI-defined lesion
- Post-void residual >100 mls, where known
- Prostate volume >90cc
- Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up
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- Unilateral or bilateral total hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging
- Previous pelvic radiotherapy
- Patients needing >6 months of ADT due to disease parameters as per the discretion of the treating physician
- Previous invasive malignancy within the last 2 years excluding basal or squamous cell carcinomas of the skin, low risk non-muscle invasive bladder cancer (assuming cystoscopic follow up now negative) or small renal masses on surveillance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Dr. Danny Vesprini, MD, FRCPC,, 416-480-4806 ext. 4806, Danny.Vesprini@sunnybrook.ca
Murtuza Saifuddin, M.S., 4164805000 ext. 63094, murtuza.saifuddin@sunnybrook.ca
About this study
Official title: A Pilot Study of Dose dE-eScalaTion IN prostATe radIOtherapy usiNg the MRL
This study is a single centre feasibility trial. The trial will recruit men with intermediate risk localised prostate cancer who will all receive targeted dose (escalated/de-escalated dose directed by MRI) 5 fraction SBRT to the prostate.
Trial Objectives are:
- Primary To develop a 5 fraction de-escalated dose SBRT protocol capable of reducing side effects
- Secondary
- To assess levels of acute GU and GI toxicity (CTCAE)
- To assess levels of late GU and GI toxicity (CTCAE)
- To assess late sexual quality of life (expanded EPIC, IIEF-5)
- To assess biochemical relapse-free survival at 2
Read the detailed description
TRIAL POPULATION: Men with intermediate risk localized prostate cancer TRIAL TREATMENT: All radiotherapy will be delivered on the MR-linac. Intraprostatic dose will be varied according to risk of local recurrence, based on mpMRI, PSA and histology. The whole prostate will receive 30 Gy in 5 fractions and the dominant lesion plus intra-prostatic margin will receive an isotoxic 45 Gy prescription.
Study rationale: The DESTINATION project aims to establish whether focusing radiation dose on the area most at risk of recurrence, and reducing the dose elsewhere, can produce a low level of side effects and maximize quality of life. This trial will assess technical feasibility of this approach.
TRIAL DESIGN: DESTINATION is run as a single centre trial embedded within the Sunnybrook REB approved MOMENTUM collaboration. The MOMENTUM trial facilitates data sharing across participating institutes.
Patients will be reviewed and complete toxicity assessments (CTCAE version 5) at the end of their radiation and then at 4 and 12 weeks after completion of treatment. They will thereafter be assessed at 6, 12 and 24 months with CTCAE version 5 and the patient reported IPSS assessment completed at each time point. Thereafter follow up will be as per standard care. Patient reported EPIC-26 will be measured at; baseline, 4 and 12 weeks, and 6, 12 and 24 months from the end of radiotherapy. IIEF-5 will be completed at months 6, 12 and 24. Scans will be taken before and during radiotherapy on the MR-linac. Patients will be followed up for recurrence/biochemical failure on protocol for 24 months and thereafter as per standard of care.
- Conditions
- Prostate Cancer
- Being tested
- MR Linac delivered Radiotherapy
- Keywords
- Newly diagnosed intermediate risk localized prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR Linac delivered RadiotherapyRadiation
All radiotherapy will be delivered on the MR-linac. The whole prostate will receive 30 Gy in 5 fractions and the dominant lesion plus intra-prostatic margin will receive an isotoxic 45 Gy prescription.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | All radiotherapy will be delivered on the MR-linac Receives: Radiation: MR Linac delivered Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Feasibility
To establish the technical feasibility of treating prostate cancer with toxicity-minimising. radiotherapy on an MR-linac. Patients will be followed up for recurrence/biochemical failure as per standard care.
Measured: 4 years
Secondary outcomes (1)
Acute and Late Toxicities
CTCAE Version 5
Measured: Upto 2 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start11 Dec 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single centre phase II non-randomized study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danny Vesprini, M.D., Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177093
- Sponsor's protocol ID
- 5761
- Acronym
- DESTINATION-MR
- Status last verified
- May 2026
- First submitted
- 11 Dec 2023
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Cooper S, Alexander S, Cherry C, Chick J, Dassen MG, Dunlop A, Hassan S, Herbert T, Mason F, Mitchell A, Nill S, Oelfke U, Pos F, Saifuddin M, Westley R, van der Heide UA, Vesprini D, Tree A. Acute adverse events in the DESTINATION 1 trial: A prospective prostate SBRT dose de-escalation feasibility study. Radiother Oncol. 2026 Mar;216:111363. doi: 10.1016/j.radonc.2026.111363. Epub 2026 Jan 6.
PubMed 41506574
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Dose dE-eScalaTion IN prostATe radIOtherapy usiNg the MRL
- ClinicalTrials.gov ID
- NCT06177093
- Acronym / sponsor ID
- DESTINATION-MR / 5761
- Conditions
- Prostate Cancer
- Keywords
- Newly diagnosed intermediate risk localized prostate cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 20 Dec 2023 (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.
This study is a single centre feasibility trial. The trial will recruit men with intermediate risk localised prostate cancer who will all receive targeted dose (escalated/de-escalated dose directed by MRI) 5 fraction SBRT to the prostate.
Trial Objectives are:
- Primary To develop a 5 fraction de-escalated dose SBRT protocol capable of reducing side effects
- Secondary
- To assess levels of acute GU and GI toxicity (CTCAE)
- To assess levels of late GU and GI toxicity (CTCAE)
- To assess late sexual quality of life (expanded EPIC, IIEF-5)
- To assess biochemical relapse-free survival at 2
Detailed description
TRIAL POPULATION: Men with intermediate risk localized prostate cancer TRIAL TREATMENT: All radiotherapy will be delivered on the MR-linac. Intraprostatic dose will be varied according to risk of local recurrence, based on mpMRI, PSA and histology. The whole prostate will receive 30 Gy in 5 fractions and the dominant lesion plus intra-prostatic margin will receive an isotoxic 45 Gy prescription.
Study rationale: The DESTINATION project aims to establish whether focusing radiation dose on the area most at risk of recurrence, and reducing the dose elsewhere, can produce a low level of side effects and maximize quality of life. This trial will assess technical feasibility of this approach.
TRIAL DESIGN: DESTINATION is run as a single centre trial embedded within the Sunnybrook REB approved MOMENTUM collaboration. The MOMENTUM trial facilitates data sharing across participating institutes.
Patients will be reviewed and complete toxicity assessments (CTCAE version 5) at the end of their radiation and then at 4 and 12 weeks after completion of treatment. They will thereafter be assessed at 6, 12 and 24 months with CTCAE version 5 and the patient reported IPSS assessment completed at each time point. Thereafter follow up will be as per standard care. Patient reported EPIC-26 will be measured at; baseline, 4 and 12 weeks, and 6, 12 and 24 months from the end of radiotherapy. IIEF-5 will be completed at months 6, 12 and 24. Scans will be taken before and during radiotherapy on the MR-linac. Patients will be followed up for recurrence/biochemical failure on protocol for 24 months and thereafter as per standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single centre phase II non-randomized study
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Radiation: MR Linac delivered RadiotherapyAll radiotherapy will be delivered on the MR-linac |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men aged ≥18 years
- Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy
- Gleason score 3+3, 3+4 or 4+3 (Grade groups 1, 2 or 3)
- MRI stage T2 or less (as staged by AJCC TNM 2018)
- MRI-visible tumour(s) of PIRADS v2 grade 3 or higher on T2 and diffusion-weighted imaging and/or dynamic contrast-enhanced imaging (multiparametric MRI or mpMRI) with concordant pathology
Key exclusion criteria (10 listed)
- Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)
- IPSS 19 or higher
- High grade disease (GG3) occult to MRI-defined lesion
- Post-void residual >100 mls, where known
- Prostate volume >90cc
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 |
|---|---|---|
| MR Linac delivered RadiotherapyAll radiotherapy will be delivered on the MR-linac. The whole prostate will receive 30 Gy in 5 fractions and the dominant lesion plus intra-prostatic margin will receive an isotoxic 45 Gy prescription. | Radiation | Interventional |
Primary outcome
Technical Feasibility
Time frame: 4 years
To establish the technical feasibility of treating prostate cancer with toxicity-minimising. radiotherapy on an MR-linac. Patients will be followed up for recurrence/biochemical failure as per standard care.
1 secondary outcome
Acute and Late Toxicities
Time frame: Upto 2 years post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Derived from this study: PubMed 41506574Cooper S, Alexander S, Cherry C, Chick J, Dassen MG, Dunlop A, Hassan S, Herbert T, Mason F, Mitchell A, Nill S, Oelfke U, Pos F, Saifuddin M, Westley R, van der Heide UA, Vesprini D, Tree A. Acute adverse events in the DESTINATION 1 trial: A prospective prostate SBRT dose de-escalation feasibility study. Radiother Oncol. 2026 Mar;216:111363. doi: 10.1016/j.radonc.2026.111363. Epub 2026 Jan 6.
- Individual participant dataSharing planned: No
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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.
Danny Vesprini, M.D. principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR Linac delivered Radiotherapy in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre at 1 site 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 11 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danny Vesprini, M.D. (416-480-4806 ext. 4806, Danny.Vesprini@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Feasibility (time frame: 4 years). 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 NCT06177093, which also lists 2 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 15 May 2026.