BridgeMD
New treatment option for Prostate Cancer
Official title Dose dE-eScalaTion IN prostATe radIOtherapy usiNg an MR-Linac in 2 Fractions
ClinicalTrials.gov ID: NCT06638541
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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
- 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...
You likely can't join if
- 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)...
- Prostate volume \>90cc
- Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up
See the full eligibility criteria
- 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
- 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...
- The MRI-defined lesion must be confirmed as malignant on biopsies (Gleason grade must be within the limits expressed in inclusion factor 3)
- 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...
- PSA \<20 ng/ml prior to starting ADT, if used
- WHO Performance status 0-2
- Ability of the participant understand and the willingness to sign a written informed consent form.
- Willing to consent to contraception during and for 1 year after treatment when applicable.
- Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study.
- 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.
- Prostate volume \>90cc
- Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up
- Hip replacement, or other pelvic metalwork which causes significant 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 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...
- Participating in another treatment trial for prostate cancer
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Canada
- Manchester, United Kingdom
- Sutton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Canada; Manchester, United Kingdom; Sutton, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.