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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Prostate radical radiotherapy
RadiationRadiation: De-escalated radiotherapy to be delivered on the Elekta Unity MR-linac
Treatment groups
54 Participants
are divided into 2 treatment groupsGroup A: Uniform doseActive comparator 1 intervention
Group B: De-escalated doseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acute GU toxicity
To describe the absolute risk and relative risk reduction of acute genitourinary (GU) toxicity (CTCAE v5) when delivering de-escalated two fraction prostate SBRT compared to uniform dose two fraction prostate stereotactic body radiotherapy (SBRT) for intermediate risk prostate cancer.
Time frame
12 weeksSecondary outcomes
1
Acute Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) toxicity
To describe the absolute and relative risk of toxicity
Time frame
Baseline, last fraction, week 2, 4 and 122
Late Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) toxicity
To describe the absolute and relative risk of toxicity
Time frame
Month 6, 12, 243
Feasibility of radiation delivery
Feasibility- estimate percentage of fractions interrupted due to patient discomfort
Time frame
At time of treatment4
Dosimetry
Dosimetry- estimate the accumulated dose differences between the de-escalated and uniform dose delivery
Time frame
At time of treatmentSponsors and contacts
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Source ClinicalTrials.gov