PSMA-PET Guided Radiotherapy
PSMA-PETgRT
2 other identifiers
interventional
130
1 country
3
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started May 2018
Longer than P75 for phase_2 prostate-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2018
CompletedFirst Posted
Study publicly available on registry
May 15, 2018
CompletedStudy Start
First participant enrolled
May 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2027
March 13, 2025
March 1, 2025
8 years
March 19, 2018
March 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Failure-free survival
Time to failure event
5 years
Secondary Outcomes (5)
Acute and delayed toxicities
5 years
Rate of failure
5 years
Survival
5 years
Health-related quality of life
5 years
Detection yield of PSMA PET imaging
2 years
Study Arms (2)
PSMA-PETgRT
EXPERIMENTALPSMA-PET/CT imaging is performed during treatment planning. Treating physicians are informed of test results and advised to include up to 5 PSMA-PET avid sites distant to the prostate gland, if present, in the radiotherapy treatment plan.
Standard
ACTIVE COMPARATORPatient's receive standard care radiotherapy and do not undergo PSMA-PET/CT imaging.
Interventions
* 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.
Eligibility Criteria
You may qualify if:
- Enrolled in PERA (CHUM CER 17.0.32) and consented to contact for investigational trials.
- Histological diagnosis of prostate cancer planned for curative-intent radiotherapy.
- ECOG 0-1
- Charlson Cormobidity Index ≤ 4
- High-risk of distant metastases as defined by any of:
- 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.
- Subjects with newly diagnosed high-risk (NCCN) localized prostate cancer and CAPRA score 6-10.
- Subjects with a prior history of treated prostate cancer (RP or RT), and biochemical failure (Phoenix-RT or\>0.2ng/ml-RP)
- Standard staging (bone scan, CT pelvis) within 12 weeks of consent.
You may not qualify if:
- Prior androgen deprivation therapy terminated \< 12 months prior to enrollment.
- Prior or planned PET scan.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
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
Related Publications (2)
Belliveau C, Saad F, Duplan D, Petit C, Delouya G, Taussky D, Barkati M, Lambert C, Beauchemin MC, Clavel S, Mok G, Igidbashian L, Gauthier-Pare AS, Nguyen TV, McLaughlin PY, Keu KV, DaSilva JN, Juneau D, Menard C. Prostate-Specific Membrane Antigen PET-Guided Intensification of Salvage Radiotherapy After Radical Prostatectomy: A Phase 2 Randomized Clinical Trial. JAMA Oncol. 2025 Oct 2:e253746. doi: 10.1001/jamaoncol.2025.3746. Online ahead of print.
PMID: 41037308DERIVEDPetit C, Delouya G, Taussky D, Barkati M, Lambert C, Beauchemin MC, Clavel S, Mok G, Pare AG, Nguyen TV, Duplan D, Keu KV, Saad F, Juneau D, Menard C. PSMA-PET/CT-Guided Intensification of Radiation Therapy for Prostate Cancer (PSMAgRT): Findings of Detection Rate, Effect on Cancer Management, and Early Toxicity From a Phase 2 Randomized Controlled Trial. Int J Radiat Oncol Biol Phys. 2023 Jul 15;116(4):779-787. doi: 10.1016/j.ijrobp.2022.12.055. Epub 2023 Jan 11.
PMID: 36639035DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2018
First Posted
May 15, 2018
Study Start
May 15, 2018
Primary Completion (Estimated)
May 30, 2026
Study Completion (Estimated)
May 30, 2027
Last Updated
March 13, 2025
Record last verified: 2025-03