Prostate Cancer (Adenocarcinoma)DESTINATION 2NCT07391982
Dose De-escalation in Prostate Radiotherapy Using an MR-Linac in Two Fractions
A study testing uniform dose radiotherapy and De-escalated dose radiotherapy in people with Prostate Cancer (Adenocarcinoma), run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
The goal of this clinical trial is to find out whether lowering the radiation dose to parts of the prostate without visible tumor on MRI can reduce side effects while still effectively treating prostate cancer in men with low or intermediate-risk prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma)
- What is being tested?
- uniform dose radiotherapy and De-escalated dose radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Nov 2025to Dec 2028
- 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 (ISUP Grade groups (GG) 1, 2 or 3)
- 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. MRI must be performed within 3 months of trial entry
- The MRI-defined lesion must be confirmed as malignant on biopsies (any Gleason grade is sufficient as long as Gleason score is reported).
- MRI stages mT1 and T2 or mT3a with ≤ 1mm tumour outside gland AND otherwise favourable intermediate risk characteristics (Gleason 3+3, 3+4)(as staged by AJCC TNM 2018)
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- PSA <20 ng/ml prior to starting androgen deprivation therapy (ADT).
- WHO Performance status 0-2
- Ability of the participant to understand and the willingness to sign a written informed consent (IC) 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. As a guide, any pathology for which you would consider surveillance is allowed outside of the MRI-defined area.
- 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 artefact on diffusion-weighted imaging
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- Previous pelvic radiotherapy
- Patients needing >6 months of ADT due to disease parameters.
- 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.
Netherlands1 site, 1 recruiting
- Recruiting
The Netherlands Cancer Institute
Amsterdam, 1066CX
Floris Pos, MD, PhD, +31205129111, f.pos@nki.nl
l.vd.hengel@nki.nl
About this study
Official title: Dose De-escalation in Prostate Radiotherapy Using an MR-Linac in 2 Fractions
The goal of this clinical trial is to find out whether lowering the radiation dose to parts of the prostate without visible tumor on MRI can reduce side effects while still effectively treating prostate cancer in men with low or intermediate-risk prostate cancer.
The main questions it aims to answer are:
Read more
- Does reducing the radiation dose to healthy prostate tissue lower the risk of bowel and urinary side effects?
- Can we maintain good cancer control by keeping a high dose for MRI-visible tumor areas?
Researchers will compare two treatment approaches:
- One group receives a uniform high dose to the entire prostate.
- The other group receives a lower dose to healthy prostate tissue and a high dose only to visible tumor areas.
Participants will:
- Receive two sessions of MRI-guided radiotherapy using an MR-Linac.
- Complete questionnaires about urinary, bowel, and sexual health before and after treatment.
- Have follow-up visits to monitor side effects and PSA levels for up to 2 years.
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Being tested
- uniform dose radiotherapy, De-escalated dose radiotherapy
- Keywords
- De-escalation, Radiotherapy, MR-Linac
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uniform dose radiotherapyRadiation
27 Gy dose in 2 fractions to the whole prostate+/- seminal vesicles with a 0mm PTV margin using MR-linac
De-escalated dose radiotherapyRadiation
The benign prostate +/- SV CTV will receive 20 Gy in 2 fractions with a 0mm PTV margin using MR-linac. The intraprostatic tumor masses (on MRI) will receive 27 Gy in 2 fractions. A 4mm GTV to PTV margin will be added to the in-traprostatic MR visible tumour to form PTV 27Gy.
| Study group | Role | What they receive |
|---|---|---|
| Uniform dose SBRT | Other | Not described Receives: Radiation: uniform dose radiotherapy |
| De-escalated dose SBRT | Other | Not described Receives: Radiation: De-escalated dose radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute GU toxicity
Physician-reported acute Grade 2 or higher CTCAE GU toxicity observed within 13 weeks of starting radiotherapy
Measured: within 13 weeks of starting radiotherapy
Secondary outcomes (9)
Dosimetry
Estimate the accumulated dose differences between treatment arms in terms of dose to prostate CTV, rectum, urethra and bladder
Measured: During Radiotherapy treatment of 8 days
Late GI toxicity
Physician reported late GI toxicity according to CTCAE v5.0
Measured: 1 and 2 years after radiotherapy treatment
Biochemical relapse-free survival
Assess biochemical relapse-free survival for 2 years
Measured: 2 years
Severity of erectile dysfunction experienced by patient
The IIEF-5 patient reported outcomes (PROs) assess the acute severity of erectile dysfunction
Measured: Before radiotherapy treatment, and at 6, 12 and 24 months after radiotherapy treatment
Acute GI toxicity
Physician reported acute GI toxicity according to CTCAE v5.0
Measured: At baseline, after the last fraction, and 2, 4 and 12 weeks after radiotherapy treatment
Late GU toxicity
Physician reported late GU toxicity according to CTCAE v5.0
Measured: 1 and 2 years after radiotherapy treatment
Late sexual toxicity
Physician reported late sexual toxicity according to CTCAE v5.0
Measured: 1 and 2 years after radiotherapy treatment
Severity of urinary symptoms (GU) experienced by patient
The patient reported outcomes (PROs) International Prostate Symptoms Score (IPSS) assess the severity of urinary symptoms what the patient experiences
Measured: Before radiotherapy treatment, after the last fraction, at 2, 4 and 12 weeks post-treatment, and at 6, 12 and 24 months after radiotherapy treatment
Health-related quality of life experienced by patient
The EPIC-26 patient reported outcomes (PROs) assess the health-related quality of life
Measured: Before start radiotherapy, week 4 and week 12, at 6, 12 and 24 months after radiotherapy treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start17 Nov 2025
- Primary completionFeb 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- MRL Consortium, Elekta Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391982
- Sponsor's protocol ID
- M24DTI
- Acronym
- DESTINATION 2
- Status last verified
- Feb 2026
- First submitted
- 2 Oct 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 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
- ClinicalTrials.gov ID
- NCT07391982
- Acronym / sponsor ID
- DESTINATION 2 / M24DTI
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Keywords
- De-escalation, Radiotherapy, MR-Linac
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- MRL Consortium, Elekta Limited
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Feb 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.
The goal of this clinical trial is to find out whether lowering the radiation dose to parts of the prostate without visible tumor on MRI can reduce side effects while still effectively treating prostate cancer in men with low or intermediate-risk prostate cancer.
The main questions it aims to answer are:
- Does reducing the radiation dose to healthy prostate tissue lower the risk of bowel and urinary side effects?
- Can we maintain good cancer control by keeping a high dose for MRI-visible tumor areas?
Researchers will compare two treatment approaches:
- One group receives a uniform high dose to the entire prostate.
- The other group receives a lower dose to healthy prostate tissue and a high dose only to visible tumor areas.
Participants will:
- Receive two sessions of MRI-guided radiotherapy using an MR-Linac.
- Complete questionnaires about urinary, bowel, and sexual health before and after treatment.
- Have follow-up visits to monitor side effects and PSA levels for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uniform dose SBRT | Other | Radiation: uniform dose radiotherapy |
| De-escalated dose SBRT | Other | Radiation: De-escalated dose radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men aged ≥18 years
- Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy
- Gleason score 3+3, 3+4 or 4+3 (ISUP Grade groups (GG) 1, 2 or 3)
- 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. MRI must be performed within 3 months of trial entry
- The MRI-defined lesion must be confirmed as malignant on biopsies (any Gleason grade is sufficient as long as Gleason score is reported).
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. As a guide, any pathology for which you would consider surveillance is allowed outside of the MRI-defined area.
- 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 |
|---|---|---|
| uniform dose radiotherapy27 Gy dose in 2 fractions to the whole prostate+/- seminal vesicles with a 0mm PTV margin using MR-linac | Radiation | Uniform dose SBRT |
| De-escalated dose radiotherapyThe benign prostate +/- SV CTV will receive 20 Gy in 2 fractions with a 0mm PTV margin using MR-linac. The intraprostatic tumor masses (on MRI) will receive 27 Gy in 2 fractions. A 4mm GTV to PTV margin will be added to the in-traprostatic MR visible tumour to form PTV 27Gy. | Radiation | De-escalated dose SBRT |
Primary outcome
Acute GU toxicity
Time frame: within 13 weeks of starting radiotherapy
Physician-reported acute Grade 2 or higher CTCAE GU toxicity observed within 13 weeks of starting radiotherapy
9 secondary outcomes
Dosimetry
Time frame: During Radiotherapy treatment of 8 days
Late GI toxicity
Time frame: 1 and 2 years after radiotherapy treatment
Biochemical relapse-free survival
Time frame: 2 years
Severity of erectile dysfunction experienced by patient
Time frame: Before radiotherapy treatment, and at 6, 12 and 24 months after radiotherapy treatment
Acute GI toxicity
Time frame: At baseline, after the last fraction, and 2, 4 and 12 weeks after radiotherapy treatment
Late GU toxicity
Time frame: 1 and 2 years after radiotherapy treatment
Late sexual toxicity
Time frame: 1 and 2 years after radiotherapy treatment
Severity of urinary symptoms (GU) experienced by patient
Time frame: Before radiotherapy treatment, after the last fraction, at 2, 4 and 12 weeks post-treatment, and at 6, 12 and 24 months after radiotherapy treatment
Health-related quality of life experienced by patient
Time frame: Before start radiotherapy, week 4 and week 12, at 6, 12 and 24 months after radiotherapy 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 6 Feb 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing uniform dose radiotherapy and De-escalated dose radiotherapy in people with Prostate Cancer (Adenocarcinoma), run by The Netherlands Cancer Institute at 1 site in Netherlands.
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 10 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: looking for participants now, as of the sponsor's last update on 6 Feb 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 Netherlands. 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 Floris Pos, MD, PhD (+31205129111, f.pos@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute GU toxicity (time frame: within 13 weeks of starting radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2026.