Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy for Prostate Cancer
University Health Network, Toronto
80 participants
Aug 5, 2022
INTERVENTIONAL
Conditions
Summary
This is a Phase II prospective sing-arm trial that is recruiting 60 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.
Eligibility
Inclusion Criteria6
- 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 Criteria4
- Presence of para-aortic lymph nodes or distant metastasis.
- Chronic pelvic inflammatory disease.
- Contraindication for radiation treatment.
- Previous radiation treatment within the pelvis
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05328505