Intermediate Risk Prostate Cancer (Diagnosis)DESTINATION 2NCT07674225
Dose-dEscalated MR-Guided Radiotherapy for Localized Prostate Cancer
A study testing Prostate radical radiotherapy in people with Intermediate Risk Prostate Cancer (Diagnosis) and Prostate Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
DESTINATION 2 is a multi-centre randomised trial treating intermediate risk localised prostate cancer with 2 fraction Stereotactic Body Radiotherapy (SBRT). All radiotherapy will be delivered in two fractions (sessions) on an MR Linac using daily adaptation. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Intermediate Risk Prostate Cancer (Diagnosis), Prostate Cancer
- What is being tested?
- Prostate radical radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 22 Mar 2026to 1 Jun 2030
- 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 (GG) 1, 2 or 3)
- MRI stage T3a or less (as staged by AJCC TNM 2018). MRI must be performed within a year of randomisation
- MRI-visible tumour(s) of PIRADS v2 grade 3 or higher and able to be delineated on T2 and diffusion-weighted imaging +/- dynamic contrast-enhanced imaging. Tumour nodule visible on MRI should be considered able to be boosted by treating clinician and <2.5cm in maximal dimension
- The MRI-defined lesion must be confirmed as malignant on biopsies (Gleason grade must be within the limits expressed in inclusion factor 3)
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- Short course (< 6 months) concurrent androgen deprivation therapy (antiandrogens or LHRH analogues) allowed though not mandated as per the discretion of the treating physician.
- PSA <20 ng/ml prior to starting ADT, if used
- 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 Score > 19
- High grade disease (GG3) occult to MRI-defined lesion.
- Prostate volume >90cc
- Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up
- Hip replacement, or other pelvic metalwork which causes significant artefact on diffusion-weighted imaging
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- 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 where this is likely to shorten lifespan the following will remain eligible: basal or squamous 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.
About this study
Official title: Dose dE-eScalaTion IN prostATe radIOtherapy usiNg an MR-Linac in 2 Fractions - a Randomised Trial
DESTINATION 2 is a multi-centre randomised trial treating intermediate risk localised prostate cancer with 2 fraction Stereotactic Body Radiotherapy (SBRT). All radiotherapy will be delivered in two fractions (sessions) on an MR Linac using daily adaptation. Men will either receive uniform dose radiotherapy or de-escalated dose radiotherapy. The primary endpoint is acute GU CTCAE v5 grade 2+ toxicity. It will also look at late toxicity, patient-reported outcome measures and PSA control.
Read the detailed description
24 patients meeting inclusion criteria will be randomised between two arms. Arm 1 (Uniform dose) will receive 27 Gy in 2 fractions to the whole prostate + seminal vesicles (SV), the CTV, with 0 mm CTV-PTV margin. Arm 2 (De-escalated dose) will use two dose levels: The benign prostate (on MRI) will receive 20 Gy in 2 fractions with a 0mm PTV margin. The intraprostatic tumour mass(es) as seen on MRI will receive 27 Gy in 2 fractions. A 4mm GTV-PTV margin will be added to the MR visible tumour to form PTV 27Gy. The primary endpoint is emergent acute GU CTCAE v5 Grade 2+ toxicity, recorded within 3 months of completing radiotherapy. Secondary endpoints are CT CAE v5 acute GI toxicity, late toxicity, patient-reported outcome measures (PROMs) (EPIC-26, IPSS, and IIEF-5) at 4 and 12 weeks, 6 months, 1 and 2 years post treatment, PSA control and kinetics
- Being tested
- Prostate radical radiotherapy
- Keywords
- DESTINATION 2,, Prostate Cancer, Intermediate Risk Prostate Cancer, MR-Linac
- Medical subject headings
- Disease, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate radical radiotherapyRadiation
All radiotherapy will be delivered in two fractions (sessions) on an MR Linac using daily adaptation.
Prostate radical radiotherapyRadiation
All radiotherapy will be delivered in two fractions (sessions) on an MR Linac using daily adaptation
| Study group | Role | What they receive |
|---|---|---|
| Uniform dose | Active comparator | Arm 1 (Uniform dose) will receive 27 Gy in 2 fractions to the whole prostate + seminal vesicles (SV), the CTV, with 0 mm CTV-PTV margin. Receives: Radiation: Prostate radical radiotherapy |
| De-escalated dose | Experimental | Arm 2 (De-escalated dose) will use two dose levels:
The benign prostate (on MRI) will receive 20 Gy in 2 fractions with a 0mm PTV margin.
The intraprostatic tumour mass(es) as seen on MRI will receive 27 Gy in 2 fractions. A 4mm GTV-PTV margin will be added to the MR visible tumour to form PTV 27Gy. Receives: Radiation: Prostate radical radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute GU toxicity
To describe the absolute risk and relative risk reduction of acute genitourinary (GU) toxicity (CTCAE v5) when delivering de-escalated two fraction prostate SBRT compared to uniform dose two fraction prostate stereotactic body radiotherapy (SBRT) for intermediate risk prostate cancer.
Measured: 12 weeks
Secondary outcomes (8)
Acute Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) toxicity
To describe the absolute and relative risk of toxicity
Measured: Baseline, at completion of radiotherapy, Week 2, Week 4, and Week 12
Late Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) toxicity
To describe the absolute and relative risk of toxicity
Measured: Month 6, 12, 24
Feasibility of radiation delivery
Feasibility- estimate percentage of fractions interrupted due to patient discomfort
Measured: During each treatment fraction
Dosimetry
Dosimetry- estimate the accumulated dose differences between the de-escalated and uniform dose delivery
Measured: During each treatment fraction
Patient reported outcome measures
To assess baseline, acute and late International Prostate Symptom Score (IPSS). IPSS ranges from 0 to 35. Lower scores are better: A lower score indicates fewer or less severe urinary symptoms, while a higher score suggests more severe symptoms.
Measured: Baseline, at completion of radiotherapy, Week 2, Week 4, Week 12, 6 months, 1 year, and 2 years after treatment completion
Patient reported outcome measures
Expanded Prostate Cancer Index Composite Short Form (EPIC-26). EPIC-26 scores are transformed to a 0-100 scale for each domain.The questionnaire usually covers urinary incontinence, urinary irritative/obstructive symptoms, bowel, sexual, and hormonal functions. Higher scores represent better health-related quality of life.
Measured: Baseline, 4 and 12 weeks, 6 months, 1 and 2 years post treatment.
Patient reported outcome measures
International Index of Erectile Function-5 (IIEF-5). The IIEF-5 score ranges from 5 to 25. Higher scores are better: A higher score indicates better erectile function, while a lower score suggests more severe erectile dysfunction.
Measured: Baseline, 6 months, 1 and 2 years post treatment.
PSA kinetics
To assess biochemical relapse-free survival at 2 years
Measured: Baseline (prior to starting ADT), Week 12, Month 6, Year 1, and Year 2 after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start22 Mar 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intermediate Risk Prostate Cancer (Diagnosis)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Elekta Limited, MRL Consortium
- Responsible party
- Sponsor
- Investigators
- Dr. Danny Vesprini, MSc, MD, FRCPC, Principal investigator, Sunnybrook Odette Cancer Centre, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674225
- Sponsor's protocol ID
- 6617
- Acronym
- DESTINATION 2
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is intended that data will be shared within the MOMENTUM collaboration, between centres delivering treatment in the same way as DESTINATION2. Pseudonymised data will be stored within MOMENTUM for at least 5 years. Storage will be cloud based and as the treating centre we will have free access to the data and control over who else can assess it.
Publications
Dess RT, Hartman HE, Aghdam N, Jackson WC, Soni PD, Abugharib AE, Suy S, Desai NB, Zumsteg ZS, Mehra R, Morgan TM, Feng FY, Hamstra DA, Schipper MJ, Collins SP, Spratt DE. Erectile function after stereotactic body radiotherapy for localized prostate cancer. BJU Int. 2018 Jan;121(1):61-68. doi: 10.1111/bju.13962. Epub 2017 Aug 17.
PubMed 28710895Brand DH, Tree AC, Ostler P, van der Voet H, Loblaw A, Chu W, Ford D, Tolan S, Jain S, Martin A, Staffurth J, Camilleri P, Kancherla K, Frew J, Chan A, Dayes IS, Henderson D, Brown S, Cruickshank C, Burnett S, Duffton A, Griffin C, Hinder V, Morrison K, Naismith O, Hall E, van As N; PACE Trial Investigators. Intensity-modulated fractionated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): acute toxicity findings from an international, randomised, open-label, phase 3, non-inferiority trial. Lancet Oncol. 2019 Nov;20(11):1531-1543. doi: 10.1016/S1470-2045(19)30569-8. Epub 2019 Sep 17.
PubMed 31540791Dearnaley 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 27339115Sung 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 33538338
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose dE-eScalaTion IN prostATe radIOtherapy usiNg an MR-Linac in 2 Fractions - a Randomised Trial
- ClinicalTrials.gov ID
- NCT07674225
- Acronym / sponsor ID
- DESTINATION 2 / 6617
- Keywords
- DESTINATION 2,, Prostate Cancer, Intermediate Risk Prostate Cancer, MR-Linac
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Elekta Limited, MRL Consortium
- Study start
- 22 Mar 2026 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 29 Jun 2026 (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.
DESTINATION 2 is a multi-centre randomised trial treating intermediate risk localised prostate cancer with 2 fraction Stereotactic Body Radiotherapy (SBRT). All radiotherapy will be delivered in two fractions (sessions) on an MR Linac using daily adaptation. Men will either receive uniform dose radiotherapy or de-escalated dose radiotherapy. The primary endpoint is acute GU CTCAE v5 grade 2+ toxicity. It will also look at late toxicity, patient-reported outcome measures and PSA control.
Detailed description
24 patients meeting inclusion criteria will be randomised between two arms. Arm 1 (Uniform dose) will receive 27 Gy in 2 fractions to the whole prostate + seminal vesicles (SV), the CTV, with 0 mm CTV-PTV margin. Arm 2 (De-escalated dose) will use two dose levels: The benign prostate (on MRI) will receive 20 Gy in 2 fractions with a 0mm PTV margin. The intraprostatic tumour mass(es) as seen on MRI will receive 27 Gy in 2 fractions. A 4mm GTV-PTV margin will be added to the MR visible tumour to form PTV 27Gy. The primary endpoint is emergent acute GU CTCAE v5 Grade 2+ toxicity, recorded within 3 months of completing radiotherapy. Secondary endpoints are CT CAE v5 acute GI toxicity, late toxicity, patient-reported outcome measures (PROMs) (EPIC-26, IPSS, and IIEF-5) at 4 and 12 weeks, 6 months, 1 and 2 years post treatment, PSA control and kinetics
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uniform dose | Active comparator | Radiation: Prostate radical radiotherapyArm 1 (Uniform dose) will receive 27 Gy in 2 fractions to the whole prostate + seminal vesicles (SV), the CTV, with 0 mm CTV-PTV margin. |
| De-escalated dose | Experimental | Radiation: Prostate radical radiotherapyArm 2 (De-escalated dose) will use two dose levels: The benign prostate (on MRI) will receive 20 Gy in 2 fractions with a 0mm PTV margin. The intraprostatic tumour mass(es) as seen on MRI will receive 27 Gy in 2 fractions. A 4mm GTV-PTV margin will be added to the MR visible tumour to form PTV 27Gy. |
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 (GG) 1, 2 or 3)
- MRI stage T3a or less (as staged by AJCC TNM 2018). MRI must be performed within a year of randomisation
- MRI-visible tumour(s) of PIRADS v2 grade 3 or higher and able to be delineated on T2 and diffusion-weighted imaging +/- dynamic contrast-enhanced imaging. Tumour nodule visible on MRI should be considered able to be boosted by treating clinician and <2.5cm in maximal dimension
Key exclusion criteria (9 listed)
- Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)
- IPSS Score > 19
- High grade disease (GG3) occult to MRI-defined lesion.
- Prostate volume >90cc
- Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up
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 |
|---|---|---|
| Prostate radical radiotherapyAll radiotherapy will be delivered in two fractions (sessions) on an MR Linac using daily adaptation. | Radiation | Uniform dose |
| Prostate radical radiotherapyAll radiotherapy will be delivered in two fractions (sessions) on an MR Linac using daily adaptation | Radiation | De-escalated dose |
Primary outcome
Acute GU toxicity
Time frame: 12 weeks
To describe the absolute risk and relative risk reduction of acute genitourinary (GU) toxicity (CTCAE v5) when delivering de-escalated two fraction prostate SBRT compared to uniform dose two fraction prostate stereotactic body radiotherapy (SBRT) for intermediate risk prostate cancer.
8 secondary outcomes
Acute Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) toxicity
Time frame: Baseline, at completion of radiotherapy, Week 2, Week 4, and Week 12
Late Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) toxicity
Time frame: Month 6, 12, 24
Feasibility of radiation delivery
Time frame: During each treatment fraction
Dosimetry
Time frame: During each treatment fraction
Patient reported outcome measures
Time frame: Baseline, at completion of radiotherapy, Week 2, Week 4, Week 12, 6 months, 1 year, and 2 years after treatment completion
Patient reported outcome measures
Time frame: Baseline, 4 and 12 weeks, 6 months, 1 and 2 years post treatment.
Patient reported outcome measures
Time frame: Baseline, 6 months, 1 and 2 years post treatment.
PSA kinetics
Time frame: Baseline (prior to starting ADT), Week 12, Month 6, Year 1, and Year 2 after treatment completion
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 3 Sep 2026.
- Background: PubMed 28710895Dess RT, Hartman HE, Aghdam N, Jackson WC, Soni PD, Abugharib AE, Suy S, Desai NB, Zumsteg ZS, Mehra R, Morgan TM, Feng FY, Hamstra DA, Schipper MJ, Collins SP, Spratt DE. Erectile function after stereotactic body radiotherapy for localized prostate cancer. BJU Int. 2018 Jan;121(1):61-68. doi: 10.1111/bju.13962. Epub 2017 Aug 17.
- Background: PubMed 31540791Brand DH, Tree AC, Ostler P, van der Voet H, Loblaw A, Chu W, Ford D, Tolan S, Jain S, Martin A, Staffurth J, Camilleri P, Kancherla K, Frew J, Chan A, Dayes IS, Henderson D, Brown S, Cruickshank C, Burnett S, Duffton A, Griffin C, Hinder V, Morrison K, Naismith O, Hall E, van As N; PACE Trial Investigators. Intensity-modulated fractionated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): acute toxicity findings from an international, randomised, open-label, phase 3, non-inferiority trial. Lancet Oncol. 2019 Nov;20(11):1531-1543. doi: 10.1016/S1470-2045(19)30569-8. Epub 2019 Sep 17.
- 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.
- 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.
- Individual participant dataSharing planned: Yes. It is intended that data will be shared within the MOMENTUM collaboration, between centres delivering treatment in the same way as DESTINATION2. Pseudonymised data will be stored within MOMENTUM for at least 5 years. Storage will be cloud based and as the treating centre we will have free access to the data and control over who else can assess it.
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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. This study is not recruiting at the moment.
Dr. Danny Vesprini, MSc, MD, FRCPC principal investigator
Sunnybrook Odette Cancer Centre, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostate radical radiotherapy in people with Intermediate Risk Prostate Cancer (Diagnosis) and 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 9 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: under way, not looking for participants, as of the sponsor's last update on 3 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute GU toxicity (time frame: 12 weeks). 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 NCT07674225, which also lists 4 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 3 Sep 2026.