NCT07515651: MIDAS-SBRT

Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy Using SBRT for Prostate Cancer to Reduce Treatment Toxicity

Not yet recruiting Phase 2 Last updated 7 April 2026

What this trial tests

Phase 2 trial testing Image-guided Radiotherapy in Prostate Cancer (Adenocarcinoma) in 50 participants. Not yet recruiting.

Timeline

1 May 2026

Primary endpoint
1 May 2034

1 May 2034

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 May 2026
Primary completion	1 May 2034
Estimated completion	1 May 2034
Sites	1 location across Canada

Drugs / interventions tested

• Image-guided Radiotherapy

Conditions studied

• Prostate Cancer (Adenocarcinoma) — all drugs for Prostate Cancer (Adenocarcinoma) →

Sponsor

University Health Network, Toronto

Who can join

18 and older, male only, with Prostate Cancer (Adenocarcinoma). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single arm trial that is recruiting a total of 50 participants that have been diagnosed with prostate bed (where the prostate was taken out) or regional (surrounding lymph nodes) recurrence of a prostate cancer following surgery. Salvage radiation treatment represents the main treatment option, with long-term cure rates on the order of 70%. Currently, salvage radiation treatment to the prostate bed and the pelvic lymph nodes is delivered using external beam radiation therapy (EBRT) in 20-33 sessions, over 4-6.5 weeks. Potential study participants have undergone a PSMA PET scan, which has found recurrent cancer in the prostate bed or lymph nodes. This study will investigate personalizing your radiation treatment based on this information. Participants on this study will receive lower than standard radiation dose to areas of the surgical site which do not show evidence of disease on the scan.

This personalized radiotherapy will be delivered in 5 treatments over two weeks, rather than the four to 6 weeks which is the current standard of care. Participants will have a routine history, blood collection for PSA and hormone levels, toxicity assessment, and EPIC-26 \& IPSS questionnaires at each follow-up visit. These will take place at 1, 3, 6, 12, 24, 36, and 60 months after radiation treatment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.