Pilot Study of Dose Escalation in Prostate Radiotherapy Using the MR-Linac (DESTINATION-MRL)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorSunnybrook Health Sciences Centre

About this trial

This study is a single centre feasibility trial. The trial will recruit men with intermediate risk localised prostate cancer who will all receive targeted dose (escalated/de-escalated dose directed by MRI) 5 fraction SBRT to the prostate.

Trial Objectives are:

1. Primary To develop a 5 fraction de-escalated dose SBRT protocol capable of reducing side effects 2. 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • MR Linac delivered Radiotherapy

    Radiation

    All radiotherapy will be delivered on the MR-linac. The whole prostate will receive 30 Gy in 5 fractions and the dominant lesion plus intra-prostatic margin will receive an isotoxic 45 Gy prescription.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: InterventionalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Technical Feasibility

To establish the technical feasibility of treating prostate cancer with toxicity-minimising. radiotherapy on an MR-linac. Patients will be followed up for recurrence/biochemical failure as per standard care.

Time frame
4 years

Secondary outcomes

1

Acute and Late Toxicities

CTCAE Version 5

Time frame
Upto 2 years post treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.