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| ID | Type | Description | Link |
|---|---|---|---|
| PERA GU17.1 | Registry Identifier | PERA |
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| Name | Class |
|---|---|
| Progenics Pharmaceuticals, Inc. | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSMA-PETgRT | Experimental | PSMA-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 Comparator | Patient's receive standard care radiotherapy and do not undergo PSMA-PET/CT imaging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSMA -PET/CT simulation | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Failure-free survival | Time to failure event | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Acute and delayed toxicities | Rate of Attributable Gr2+ toxicities (CTCAE v4.0) | 5 years |
| Rate of failure | Event rates | 5 years |
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Inclusion Criteria:
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:
Standard staging (bone scan, CT pelvis) within 12 weeks of consent.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CSSSL - Cité de la Santé Laval | Laval | Quebec | Canada | |||
| Centre Hospitalier de l'Université de Montréal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41037308 | Derived | 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 Dec 1;11(12):1431-1438. doi: 10.1001/jamaoncol.2025.3746. | |
| 36639035 |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Patients are randomly selected from a standard-care cohort.
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|
| Standard-care simulation | Radiation | No PSMA-PET/CT as part of RT treatment planning. |
|
| Survival | Event rates | 5 years |
| Health-related quality of life | Qol measures | 5 years |
| Detection yield of PSMA PET imaging | Rate of new lesions identified on imaging | 2 years |
| Montreal |
| Quebec |
| Canada |
| CHU de Québec | Québec | Quebec | Canada |
| Derived |
| Petit 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. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |