PSMA MRI Guided Prostate SBRT (ARGOS)/Comprehensive, Longitudinal Evaluation of Imaging Biomarkers Post Radiotherapy (CLIMBER)

NAActive, not recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

May 3, 2022

Primary Completion Date

December 15, 2028

Study Completion Date

December 15, 2028

Conditions
Prostate Cancer
Interventions
RADIATION

High-Intermediate Risk Patients-cohort 1

Patients will receive 35Gy/5 fractions to the whole prostate (25 Gy to proximal Seminal Vesicles) with a simultaneous boost to PET/MRI defined intra-prostatic foci to a target maximum dose of 50Gy/5 fractions. Six months of androgen deprivation therapy will commence with the end of radiotherapy (concurrent plus adjuvant)

RADIATION

High Risk or Very High-Risk Patients-cohort 1

Patients will receive 35Gy/5 fractions to the whole prostate (25Gy to whole Seminal Vesicles) with a simultaneous boost to PET/MRI defined intra-prostatic foci to a target maximum dose of 50Gy/5 fractions. Pelvic lymph nodes will receive 25Gy/5 fractions synchronous with prostate treatment with a simultaneous boost to imaging involved nodes to a maximum of 35Gy/5 fractions. Eighteen months of androgen deprivation therapy will commence with the end of radiotherapy (concurrent plus adjuvant)

RADIATION

High-Intermediate Risk Patients-cohort 2

Patients will receive 35Gy/5 fractions to the whole prostate (25 Gy to proximal Seminal Vesicles) with a simultaneous boost to PET/MRI defined intra-prostatic foci to a target maximum dose of 50Gy/5 fractions. Androgen deprivation therapy will commence 3 months before radiotherapy (concurrent plus adjuvant) and will continue for a total of 6 months.

RADIATION

High Risk or Very High-Risk Patients-cohort 2

Patients will receive 35Gy/5 fractions to the whole prostate (25 Gy to proximal Seminal Vesicles) with a simultaneous boost to PET/MRI defined intra-prostatic foci to a target maximum dose of 50Gy/5 fractions. Androgen deprivation therapy will commence 3 months before radiotherapy (concurrent plus adjuvant) and will continue for a total of 18 months.

Trial Locations (2)

N6A 5W9

London Health Sciences Centre, London

M4N3M5

Sunnybrook Research Institute, Toronto

All Listed Sponsors
lead

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER