Prostate AdenocarcinomaDESTINATIONNCT05709496
Dose De-escalation in Prostate Radiotherapy Using the MRL
A study testing De-escalated radiotherapy to be delivered on the Elekta Unity Unity MR-linac in people with Prostate Adenocarcinoma, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The goal of this feasibility study is to learn about dose de-escalation in the treatment of men with intermediate risk prostate cancer. The main question it aims to answer is the technical feasibility of treating prostate cancer with toxicity-minimising radiotherapy on an Magnetic Resonance Linear Accelerator… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- De-escalated radiotherapy to be delivered on the Elekta Unity Unity MR-linac
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2023to 1 Mar 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 Prostate Imaging-Reporting and Data System (PIRADS) v2 grade 3 or higher on T2 and diffusion-weighted imaging and/or dynamic contrast-enhanced imaging with concordant pathology
- Tumour nodule visible on MRI occupying <50% of prostate on any axial slice and <50% total prostate volume
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- PSA <20 ng/ml prior to starting androgen deprivation therapy (ADT)
- Patients can be concurrently treated with androgen deprivation therapy if this would be standard of care. Luteinizing hormone-releasing hormone (LHRH) analogues or Bicalutamide are permitted. ADT is not mandatory where this would usually be omitted.
- World Health Organisation (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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Marsden Hospital
Sutton, Surrey, SM2 5PT
Greta Bucinskaite, Ms, 02031865157, greta.bucinskaite@rmh.nhs.uk
Alison Tree, Dr.
About this study
Official title: A Feasibility Study of Dose De-escalation in Prostate Radiotherapy Using the Magnetic Resonance Linear Accelerator (MRL)
The goal of this feasibility study is to learn about dose de-escalation in the treatment of men with intermediate risk prostate cancer.
The main question it aims to answer is the technical feasibility of treating prostate cancer with toxicity-minimising radiotherapy on an Magnetic Resonance Linear Accelerator (MR-linac). It will also examine gastrointestinal and genitourinary toxicity in the acute and late setting post radiotherapy as well as Prostate-Specific antigen (PSA) control up until 2 years post treatment.
Participants will be treated with radiotherapy to the prostate with which will be given in 30Gy in 5 fractions to the whole prostate and 45Gy in 5 fractions to the dominant lesion.
Read the detailed description
DESTINATION is a single centre phase II non-randomised study in men with intermediate risk localised prostate cancer.
The aim is to establish the technical feasibility of treating prostate cancer with toxicity-minimising radiotherapy on an MR-linac.
20 men will be recruited to take part. All radiotherapy will be delivered on the MR-linac. The whole prostate with no margin will be treated to 30 Gray (Gy) in 5 fractions (i.e. dose to 95% of the Clinical Target Volume prostate should receive 30 Gy (D95%CTVp= 30 Gy)). The dominant lesion (Gross tumour volume (GTV)) as defined on pre-biopsy multiparametric magnetic resonance imaging (mpMRI) plus a 4mm intra-prostatic margin (GTV4mm) will be treated to 45 Gy in 5 fractions, providing standard organ at risk (OAR) constraints can be met. If not, then dose coverage of the GTV will be reduced until the OAR constraints are met (i.e. isotoxic dose escalation). OAR constraints will be as per international standard levels, and largely consistent with the PACE B trial.
The primary end point will be assessed once 14 patients have completed their radiotherapy treatment on the MR-Linac. If any of the first 14 patients do not complete all five fractions planned, then recruitment will continue until we have 14 assessable patients. The analysis population for the primary endpoint will be defined as those patients who have completed all five fractions of stereotactic body radiotherapy (SBRT) as intended.
If shown to be feasible a total of 20 patients will be recruited to enable a better estimation of the toxicity rates and to further technical proficiency with this technique.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- De-escalated radiotherapy to be delivered on the Elekta Unity Unity MR-linac
- Keywords
- Intermediate risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
De-escalated radiotherapy to be delivered on the Elekta Unity Unity MR-linacRadiation
30 Gy in 5 fractions to the whole prostate with 45 Gy in 5 fractions to the dominant lesion
| Study group | Role | What they receive |
|---|---|---|
| De-escalated radiotherapy to the prostate | Experimental | De-escalated radiotherapy to the prostate with an intra-prostatic boost to the dominant . Receives: Radiation: De-escalated radiotherapy to be delivered on the Elekta Unity Unity MR-linac |
What is being measured
The primary outcome is the main question the study is designed to answer.
The technical ability to treat prostate cancer with escalated dose to the gross tumour volume tumour and de-escalated dose to the normal prostate the Unity MR-linac.
The primary end point is defined by coverage of GTV4mm D90% >42Gy on the post-treatment imaging.
Measured: 2 years
Secondary outcomes (4)
Acute toxicity
Physician reported genitourinary (GU) and gastrointestinal (GI) toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) to be taken at baseline and the end of treatment then at 4 and 12 weeks post-treatment.
The higher the grade the worse the toxicity reported. Each domain will be scored individually.
Measured: 2 years
Late toxicity
Physician reported GU and gastrointestinal (GI) late toxicity (CTCAE) at 1 and 2 years post-treatment.
The CTCAE toxicity will be graded by the physician, with the higher scores equating to worse toxicity. Each domain will be scored individually.
Measured: 2 years
Patient-reported outcomes
Patient-reported outcome measures (PROMs) from the Expanded Prostate Cancer Index Composite-26 (EPIC-26), (International prostate symptom score) IPSS, and International Index of Erectile Function-5 (IIEF-5) questionnaires. Patients will be asked to complete these PROMs at 4 and 12 weeks, 6 months, 1 and 2 years post treatment.
EPIC-26 is scored out of 100, with 100 being the best score. IPPS is made of seven questions with lower scores equating to fewer symptoms. IIEF-5 is composed of 5 questions, the highest score of 25 is indicative of severe erectile dysfunction
Measured: 2 years
Biochemical control
The trend in PSA will be measured up until two years. An increase in the PSA is suggested of biochemical failure and disease relapse
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start1 Mar 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- An R-IDEAL stage 2a study aiming to demonstrate technical feasibility and establish likely toxicity rates for powering the subsequent study. Men will receive de-escalated radiotherapy to the prostate with a boost to the dominant lesion.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709496
- Sponsor's protocol ID
- CCR5715
- Acronym
- DESTINATION
- Status last verified
- Apr 2024
- First submitted
- 11 Jan 2023
- Last updated
- 19 Apr 2024
- 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 DESTINATION. Pseudonymised data will storage with in 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 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Dose De-escalation in Prostate Radiotherapy Using the Magnetic Resonance Linear Accelerator (MRL)
- ClinicalTrials.gov ID
- NCT05709496
- Acronym / sponsor ID
- DESTINATION / CCR5715
- Conditions
- Prostate Adenocarcinoma
- Keywords
- Intermediate risk
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 2 Feb 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.
The goal of this feasibility study is to learn about dose de-escalation in the treatment of men with intermediate risk prostate cancer.
The main question it aims to answer is the technical feasibility of treating prostate cancer with toxicity-minimising radiotherapy on an Magnetic Resonance Linear Accelerator (MR-linac). It will also examine gastrointestinal and genitourinary toxicity in the acute and late setting post radiotherapy as well as Prostate-Specific antigen (PSA) control up until 2 years post treatment.
Participants will be treated with radiotherapy to the prostate with which will be given in 30Gy in 5 fractions to the whole prostate and 45Gy in 5 fractions to the dominant lesion.
Detailed description
DESTINATION is a single centre phase II non-randomised study in men with intermediate risk localised prostate cancer.
The aim is to establish the technical feasibility of treating prostate cancer with toxicity-minimising radiotherapy on an MR-linac.
20 men will be recruited to take part. All radiotherapy will be delivered on the MR-linac. The whole prostate with no margin will be treated to 30 Gray (Gy) in 5 fractions (i.e. dose to 95% of the Clinical Target Volume prostate should receive 30 Gy (D95%CTVp= 30 Gy)). The dominant lesion (Gross tumour volume (GTV)) as defined on pre-biopsy multiparametric magnetic resonance imaging (mpMRI) plus a 4mm intra-prostatic margin (GTV4mm) will be treated to 45 Gy in 5 fractions, providing standard organ at risk (OAR) constraints can be met. If not, then dose coverage of the GTV will be reduced until the OAR constraints are met (i.e. isotoxic dose escalation). OAR constraints will be as per international standard levels, and largely consistent with the PACE B trial.
The primary end point will be assessed once 14 patients have completed their radiotherapy treatment on the MR-Linac. If any of the first 14 patients do not complete all five fractions planned, then recruitment will continue until we have 14 assessable patients. The analysis population for the primary endpoint will be defined as those patients who have completed all five fractions of stereotactic body radiotherapy (SBRT) as intended.
If shown to be feasible a total of 20 patients will be recruited to enable a better estimation of the toxicity rates and to further technical proficiency with this technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An R-IDEAL stage 2a study aiming to demonstrate technical feasibility and establish likely toxicity rates for powering the subsequent study. Men will receive de-escalated radiotherapy to the prostate with a boost to the dominant lesion.
| Arm | Type | Receives |
|---|---|---|
| De-escalated radiotherapy to the prostate | Experimental | Radiation: De-escalated radiotherapy to be delivered on the Elekta Unity Unity MR-linacDe-escalated radiotherapy to the prostate with an intra-prostatic boost to the dominant . |
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 Prostate Imaging-Reporting and Data System (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 radiotherapy to be delivered on the Elekta Unity Unity MR-linac30 Gy in 5 fractions to the whole prostate with 45 Gy in 5 fractions to the dominant lesion | Radiation | De-escalated radiotherapy to the prostate |
Primary outcome
The technical ability to treat prostate cancer with escalated dose to the gross tumour volume tumour and de-escalated dose to the normal prostate the Unity MR-linac.
Time frame: 2 years
The primary end point is defined by coverage of GTV4mm D90% >42Gy on the post-treatment imaging.
4 secondary outcomes
Acute toxicity
Time frame: 2 years
Late toxicity
Time frame: 2 years
Patient-reported outcomes
Time frame: 2 years
Biochemical control
Time frame: 2 years
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 19 Apr 2024.
- 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 DESTINATION. Pseudonymised data will storage with in 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 De-escalated radiotherapy to be delivered on the Elekta Unity Unity MR-linac in people with Prostate Adenocarcinoma, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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 19 Apr 2024. 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 United Kingdom. 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 Alison Tree, MBBS (02086613269, alison.tree@icr.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The technical ability to treat prostate cancer with escalated dose to the gross tumour volume tumour and de-escalated dose to the normal prostate the Unity MR-linac. (time frame: 2 years). 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 19 Apr 2024; AzTrials last refreshed its copy on 26 Oct 2026.