NCT03525288Active, not recruitingPhase 2/3
PSMA-PET Guided Radiotherapy
PSMA-PET Guided Radiotherapy in Patients With High-Risk, Recurrent, or Oligometastatic Prostate Cancer
Source: ClinicalTrials.gov · Last updated 13 Mar 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 19 Mar 2018
- Start date
- 15 May 2018
- Primary completion date
- 30 May 2026
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Diseases
- Prostate cancer
- NCT number
- NCT03525288
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 130
- From 15 May 2018 to the primary completion date, 30 May 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior androgen deprivation therapy terminated \< 12 months prior to enrollment.
- Prior or planned PET scan.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CSSSL - Cité de la Santé Laval Coordinator of this site? Confirm its status | Laval | Canada | Unknown status |
| Centre Hospitalier de l'Université de Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| CHU de Quebec Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.