NCT04557501Active, not recruitingPhase 3
PSMA PET/CT Guided Intensification of Therapy in Patients at Risk of Advanced Prostate Cancer
Source: ClinicalTrials.gov · Last updated 13 Mar 2025
Brief summary (registry, in English)
Through the conduct of a Phase III randomized controlled trial, investigators plan to: 1) determine if PSMA PET/CT guided intensification of radiotherapy or surgery improves cancer outcomes compared to conventional imaging-guided therapy in patients at risk of advanced disease, 2) evaluate its impact on toxicity and quality of life, and 3) measure the cost-effectiveness of the PSMA PET/CT guided approach. Participants with high-risk prostate cancer planned for curative-intent standard-of-care radiotherapy or surgery, or with biochemical failure after radical prostatectomy planned for salvage radiotherapy will be enrolled over 3 years (n=776). Those randomized to the investigational arm will have PSMA PET/CT prior to therapy. Based on the imaging results, treating physicians will intensify radiotherapy or surgery unless widely metastatic disease is found, in which case systemic therapy will be intensified.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 800 (actual)
- First submitted
- 14 Sept 2020
- Start date
- 6 Jan 2021
- Primary completion date
- Jan 2029
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Diseases
- Prostate cancer
- NCT number
- NCT04557501
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 800
- From 6 Jan 2021 to the primary completion date, Jan 2029
- 19 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
- Active or prior androgen deprivation therapy (except 5-alpha reductase inhibitor) terminated \< 12 months prior to enrollment.
- Prior or planned PSMA PET/CT scan outside of this clinical trial.
- Prior curative intent treatment for prostate cancer with local therapy other than surgery (primary radiotherapy or ablative therapies)
Other illness
- Evidence of extra-pelvic nodal disease (M1a) on conventional imaging (if performed)
- Evidence of metastatic disease (M1b bone, M1c viscera/soft tissue) on conventional imaging (if performed)
Other
- Charlson Comorbidity Index \> 5 (see Appendix 2).
Who the study is looking for
- Histological diagnosis of adenocarcinoma of the prostate planned for curative-intent standard-of-care radiotherapy (primary or salvage post prostatectomy) or radical prostatectomy with lymph node dissection.
- Age ≥ 18
- High risk of regional or distant metastases as defined by any of:
- Newly diagnosed and untreated prostate cancer with CAPRA score 6-10, or stage cN1.
- Prior history of radical prostatectomy and biochemical failure (PSA\>0.1ng/mL).
- Patients must provide study-specific informed consent prior to study entry.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Victoria Regional Health Centre Coordinator of this site? Confirm its status | Barrie | Canada | Unknown status |
| Tom Baker Cancer Center Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Cross Cancer Institute Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| St. Joseph's Healthcare Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Juravinski Cancer Centre Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| BC Cancer - Kelowna Coordinator of this site? Confirm its status | Kelowna | Canada | Unknown status |
| Grand River Regional Cancer Centre Coordinator of this site? Confirm its status | Kitchener | Canada | Unknown status |
| Hopital de la Cite-de-la-Sante Coordinator of this site? Confirm its status | Laval | Canada | Unknown status |
| London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Charles Lemoyne Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| CHUM Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| McGill University Health Center 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 |
| CHUS Coordinator of this site? Confirm its status | Sherbrooke | Canada | Unknown status |
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| BC Cancer - Vancouver Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Windsor Regional Cancer Centre Coordinator of this site? Confirm its status | Windsor | Canada | Unknown status |
| Cancer Care Manitoba Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.