Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy for Prostate Cancer
Recruiting · NCT05328505 · Interventional (participants receive a specific treatment) · Lead sponsor: University Health Network, Toronto
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This is a Phase II prospective single-arm trial that is recruiting 80 participants from patients that have biochemical failure after radical prostatectomy with local or regional recurrence proven by PSMA PET. Participants of this study will receive molecular imaging informed radiation dose escalation to site of recurrent disease and de-escalation to uninvolved areas. Participants will be follow-up as per standard of care up to 5 years post-treatment.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Men older than 18 years old.
- Histologically proven initial diagnosis of adenocarcinoma prostate cancer.
- Previous radical prostatectomy.
- Biochemical relapse with local or regional recurrence proven on PSMA PET.
- Five or less positive nodes on the PSMA PET.
- ECOG 0-1
Exclusion criteria
- Presence of para-aortic lymph nodes or distant metastasis.
- Chronic pelvic inflammatory disease.
- Contraindication for radiation treatment.
- Previous radiation treatment within the pelvis
Where it is running
2 locations listed.
- London Health Sciences Centre - London, Ontario, Canada
- Princess Margaret Cancer Center - Toronto, Ontario, Canada