PSMA PET/CT has demonstrated higher sensitivity in detecting metastases than current imaging standard of care (CT and bone scan). \[18F\]DCFPyL is a promising high-sensitivity second generation PSMA-targeted urea-based PET probe. The hypothesis is that definitive radiotherapy (RT) informed by PSMA-PET findings will lead to improved cancer control outcomes compared to RT guided by conventional staging only. This study utilizes cmRCT design in companion to PERA (Partnership initiative for the Evaluation of technological innovation in Radiotherapy).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
* PET/CT simulation. * If no additional lesions detected: RT as planned per standard care. * If PSMA-PET/CT imaging consistent with oligometastases (1-5 lesions): all lesions must be treated with definitive RT. * If PSMA-PET/CT imaging consistent with widely metastatic disease (\>5 lesions): treatment of all detected disease with RT is not recommended, but treatment of the primary site as initially planned is encouraged.
No PSMA-PET/CT as part of RT treatment planning.
CSSSL - Cité de la Santé Laval
Laval, Quebec, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
CHU de Québec
Québec, Quebec, Canada
Failure-free survival
Time to failure event
Time frame: 5 years
Acute and delayed toxicities
Rate of Attributable Gr2+ toxicities (CTCAE v4.0)
Time frame: 5 years
Rate of failure
Event rates
Time frame: 5 years
Survival
Event rates
Time frame: 5 years
Health-related quality of life
Qol measures
Time frame: 5 years
Detection yield of PSMA PET imaging
Rate of new lesions identified on imaging
Time frame: 2 years
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