NCT05328505

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Image-guided Radiotherapy	de-escalation radiotherapy to elective volumes + simultaneous integrated boost to PSMA avid lesions delivered in 20 fractions +/- ADT (clinical decision). The elective prostate bed and pelvic lymph node regions will receive 45 Gy. The PSMA-avid lymph node(s) will receive an SIB to 55-60 Gy and/or the PSMA-avid lesion in the prostate bed will receive an SIB to 60 Gy. Pelvic nodal treatment and ADT use will be left to the discretion of the treating physician.

Timeline

• Start date: 2022-08-23
• Primary completion: 2028-08-01
• Completion: 2030-08-01
• First posted: 2022-04-14
• Last updated: 2026-03-24

Locations

2 sites across 1 country: Canada