Dose dE-eScalaTion IN prostATe radIOtherapy usiNg an MR-Linac in 2 Fractions

Launched by ROYAL MARSDEN NHS FOUNDATION TRUST · Oct 9, 2024

Keywords

ClinConnect Summary

The DESTINATION 2 trial is a study aimed at treating men with intermediate-risk localized prostate cancer using a type of radiation therapy called Stereotactic Body Radiotherapy (SBRT). In this trial, participants will receive their treatment in just two sessions, using advanced imaging technology (MR-Linac) that allows doctors to adapt the treatment based on daily imaging. The study will compare two different approaches: one where all participants receive the same radiation dose and another where some receive a lower dose. The main goal is to see how well these treatments work while monitoring any side effects that might occur.

To join this trial, men need to be at least 18 years old and have been diagnosed with prostate cancer that meets certain criteria, like having specific Gleason scores and MRI results. Participants can expect to undergo radiation treatment in two sessions, with close monitoring by the medical team to track any side effects and their cancer control. It's important to note that this trial is not yet recruiting participants, but it offers a unique opportunity for eligible patients to contribute to research that could improve prostate cancer treatments in the future.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Men aged ≥18 years
• • 2. Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy
• • 3. Gleason score 3+3, 3+4 or 4+3 (Grade groups (GG) 1, 2 or 3)
• • 4. MRI stage T3a or less (as staged by AJCC TNM 2018). MRI must be performed within a year of randomisation
• • 5. 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
• • 6. The MRI-defined lesion must be confirmed as malignant on biopsies (Gleason grade must be within the limits expressed in inclusion factor 3)
• • 7. Patients can be concurrently treated with androgen deprivation therapy (ADT) if this would be standard of care. LHRH analogues, LHRH agonists or Bicalutamide are permitted. ADT is not mandatory where this would usually be omitted.
• • 8. PSA \<20 ng/ml prior to starting ADT, if used
• • 9. WHO Performance status 0-2
• • 10. Ability of the participant understand and the willingness to sign a written informed consent form.
• • 11. Willing to consent to contraception during and for 1 year after treatment when applicable.
• • 12. Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study.
• Exclusion Criteria:
• • 1. Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)
• • 2. Severe GU symptoms that would preclude extreme hypofractionation per the discretion of the treating physician.
• • 3. IPSS Score \> 19
• • 4. High grade disease (GG3) occult to MRI-defined lesion. As a guide, any pathology for which you would consider surveillance (eg GG1, low volume GG2) is allowed outside of the MRI-defined area.
• • 5. Prostate volume \>90cc
• • 6. Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up
• • 7. Hip replacement, or other pelvic metalwork which causes significant artefact on diffusion-weighted imaging
• • 8. Previous pelvic radiotherapy
• • 9. Patients needing \>6 months of ADT due to disease parameters.
• • 10. 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.
• • 11. Participating in another interventional trial for prostate cancer