Dose dE-eScalaTion IN prostATe radIOtherapy usiNg an MR-Linac in 2 Fractions
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorRoyal Marsden NHS Foundation Trust
About this 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)
Severe GU symptoms that would preclude extreme hypofractionation per the discretion of the treating physician.
IPSS Score > 19
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.
Trial design
Treatments tested in this trial
- Prostate radical radiotherapy
Treatment groups
54 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov