Prostate CancerDESTINATIONNCT06284304
A Pilot Study of Dose dE-eScalaTion IN prostATe radIOtherapy usiNg the MRL
A study testing De-escalated radiotherapy in people with Prostate Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
Trial design: A single centre phase II non-randomised study Trial population: Men with intermediate risk localised prostate cancer Recruitment target: 20 patients in total Trial objectives: Primary To develop a 5 fraction de-escalated dose SBRT protocol capable of reducing side effects Secondary To assess levels of… 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?
- De-escalated 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 siteNetherlands
- Study dates
- 29 Feb 2024to 4 Sep 2026
- 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
- 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 with concordant pathology
- Dominant lesion \<50% of prostate on any axial slice and \<50% total prostate volume
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- PSA \<20 ng/ml prior to starting ADT
- Patients can be concurrently treated with androgen deprivation therapy if this would be standard of care. LHRH analogues or Bicalutamide are permitted. ADT is not mandatory where this would usually be omitted.
- 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.
- 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.
About this study
Trial design: A single centre phase II non-randomised study
Trial population: Men with intermediate risk localised prostate cancer
Read more
Recruitment target: 20 patients in total
Trial objectives:
- 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 years
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 GTV plus intra-prostatic margin will receive an isotoxic 45 Gy prescription.
Read the detailed description
Primary endpoint: Technical feasibility of treating prostate cancer with toxicity- minimising radiotherapy on an MR-linac
Secondary endpoint:
- Physician reported GU and gastrointestinal (GI) toxicity (CTCAE grade) at baseline and the end of treatment then at 4 weeks and 3 months post-treatment.
- Late toxicity (CTCAE v5.0) at 1 and 2 years post-treatment
- Patient-reported outcome measures (PROMs) from the EPIC-26, IPSS, and IIEF-5 questionnaires. Patients will be asked to complete PROMs at 4 weeks, 3 and 6 months, 1 and 2 years post treatment.
- PSA control and kinetics at 2 years post-treatment
Quality of life: EPIC-26 QoL will be measured at baseline, then at 4 weeks and 3, 6, 12 and 24 months from end of treatment. IIEF-5 will be completed at baseline and months 6, 12 and 24. IPSS will be measured at all time points.
Follow-up: Patients will be assessed at 6, 12 and 24 months and then as per standard of care.
- Conditions
- Prostate Cancer
- Being tested
- De-escalated radiotherapy
- Keywords
- Radiotherapy, De-escalation, Prostate cancer, MR-Linac
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
De-escalated radiotherapyRadiation
5 fraction de-escalated dose SBRT protocol
| Study group | Role | What they receive |
|---|---|---|
| Experimental radiotherapy treatment | Experimental | SBRT 5x30Gy of whole prostate and isotoxic 45 Gy GTV plus intra-prostatic margin Receives: Radiation: De-escalated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical feasibility of treating prostate cancer with toxicity minimising radiotherapy on a MR-linac
To establish the technical feasibility of treating prostate cancer with tumour-escalated/normal prostate de-escalated dose radiotherapy on an MR-linac. Feasiblity is defined as coverage of GTV boost D90% >42Gy on the post-treatment imaging.
Measured: after 1,5 week of treatment
Secondary outcomes (6)
Acute GU toxicity
Physician-reported acute GU and GI toxicity according to the CTCAE v5.0.
Measured: within 90 days after first radiation treatment
Acute GI toxicity
Physician-reported acute GU and GI toxicity according to the CTCAE v5.0.
Measured: within 90 days after first radiation treatment
Late GU toxicity
Physician-reported late GU and GI toxicity according to the CTCAE v5.0.
Measured: After at least 90 days after the first radioation treatment up to 2 years
Late GI toxicity
Physician-reported late GU and GI toxicity according to the CTCAE v5.0.
Measured: After at least 90 days after the first radioation treatment up to 2 years
PROMs
will be assessed using the International Prostate Symptom Score (IPSS) questionnaire, the EPIC-26 questionnaire and the IIEF-5 questionnaire.
Measured: 2 years
Biochemical free survival
PSA control, biochemical failure/progression. Biochemical failure is defined a PSA nadir+ 2 ng/ml.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start29 Feb 2024
- Primary completion4 Sep 2026
- Study completion4 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Floris Pos, MD PhD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284304
- Sponsor's protocol ID
- N22DES
- Acronym
- DESTINATION
- Status last verified
- Sep 2026
- First submitted
- 5 Feb 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 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
- NCT06284304
- Acronym / sponsor ID
- DESTINATION / N22DES
- Conditions
- Prostate Cancer
- Keywords
- Radiotherapy, De-escalation, Prostate cancer, MR-Linac
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 4 Sep 2026 (actual)
- Study completion
- 4 Sep 2026 (actual)
- First posted
- 28 Feb 2024 (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.
Trial design: A single centre phase II non-randomised study
Trial population: Men with intermediate risk localised prostate cancer
Recruitment target: 20 patients in total
Trial objectives:
- 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 years
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 GTV plus intra-prostatic margin will receive an isotoxic 45 Gy prescription.
Detailed description
Primary endpoint: Technical feasibility of treating prostate cancer with toxicity- minimising radiotherapy on an MR-linac
Secondary endpoint:
- Physician reported GU and gastrointestinal (GI) toxicity (CTCAE grade) at baseline and the end of treatment then at 4 weeks and 3 months post-treatment.
- Late toxicity (CTCAE v5.0) at 1 and 2 years post-treatment
- Patient-reported outcome measures (PROMs) from the EPIC-26, IPSS, and IIEF-5 questionnaires. Patients will be asked to complete PROMs at 4 weeks, 3 and 6 months, 1 and 2 years post treatment.
- PSA control and kinetics at 2 years post-treatment
Quality of life: EPIC-26 QoL will be measured at baseline, then at 4 weeks and 3, 6, 12 and 24 months from end of treatment. IIEF-5 will be completed at baseline and months 6, 12 and 24. IPSS will be measured at all time points.
Follow-up: Patients will be assessed at 6, 12 and 24 months and then 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
| Arm | Type | Receives |
|---|---|---|
| Experimental radiotherapy treatment | Experimental | Radiation: De-escalated radiotherapySBRT 5x30Gy of whole prostate and isotoxic 45 Gy GTV plus intra-prostatic margin |
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 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 |
|---|---|---|
| De-escalated radiotherapy5 fraction de-escalated dose SBRT protocol | Radiation | Experimental radiotherapy treatment |
Primary outcome
Technical feasibility of treating prostate cancer with toxicity minimising radiotherapy on a MR-linac
Time frame: after 1,5 week of treatment
To establish the technical feasibility of treating prostate cancer with tumour-escalated/normal prostate de-escalated dose radiotherapy on an MR-linac. Feasiblity is defined as coverage of GTV boost D90% >42Gy on the post-treatment imaging.
6 secondary outcomes
Acute GU toxicity
Time frame: within 90 days after first radiation treatment
Acute GI toxicity
Time frame: within 90 days after first radiation treatment
Late GU toxicity
Time frame: After at least 90 days after the first radioation treatment up to 2 years
Late GI toxicity
Time frame: After at least 90 days after the first radioation treatment up to 2 years
PROMs
Time frame: 2 years
Biochemical free survival
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- 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. This study is not recruiting at the moment.
Floris Pos, MD PhD principal investigator
The Netherlands Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing De-escalated radiotherapy in people with Prostate Cancer, 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 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: finished, as of the sponsor's last update on 17 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Technical feasibility of treating prostate cancer with toxicity minimising radiotherapy on a MR-linac (time frame: after 1,5 week of treatment). 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 17 Sep 2026.