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Active, not recruiting Phase 2/3

PSMA-PET Guided Radiotherapy

NCT03525288 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2/3
Started
2018-05-15
Last updated
2025-03-13

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

PSMA -PET/CT simulationStandard-care simulation

PSMA -PET/CT simulation: * 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.

Standard-care simulation: No PSMA-PET/CT as part of RT treatment planning.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Enrolled in PERA (CHUM CER 17.0.32) and consented to contact for investigational trials. 2. Histological diagnosis of prostate cancer planned for curative-intent radiotherapy. 3. ECOG 0-1 4. Charlson Cormobidity Index ≤ 4 5. High-risk of distant metastases as defined by any of: 1. Oligometastases (≤5) (regional or distant) identified on conventional staging, with ≤ 3 metastasis in any non-bone organ. For a spine metastasis, direct involvement of adjacent spinal segments would still be considered as "one" tumour. For nodal metastases, more than one involved lymph node in the same ipsilateral nodal region/chain would still count as "one" tumour. Defined nodal regions for this protocol include inguinal, external iliac, internal iliac, common iliac, retroperitoneal, hilar/mediastinal, anterior cervical, posterior cervical, and axillary. Metastases in all other organs that are within 1cm of each other will be considered as "one" tumour. 2. Subjects with newly diagnosed high-risk (NCCN) localized prostate cancer and CAPRA score 6-10. 3. Subjects with a prior history of treated prostate cancer (RP or RT), and biochemical failure (Phoenix-RT or\>0.2ng/ml-RP) 6. Standard staging (bone scan, CT pelvis) within 12 weeks of consent. Exclusion Criteria: 1. Prior androgen deprivation therapy terminated \< 12 months prior to enrollment. 2. Prior or planned PET scan.

Primary outcome measure(s)

  • Failure-free survival — 5 years
    Time to failure event

Trial sites (3)

FacilityCityRegionStatus
CSSSL - Cité de la Santé Laval Laval Quebec
Centre Hospitalier de l'Université de Montréal Montreal Quebec
CHU de Québec Québec Quebec
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03525288 on ClinicalTrials.gov ↗ ← All trials in Canada