Effect of Copper CU64 PSMA I&T scanning to detect potential disease spread to lymph nodes in men with newly diagnosed Prostate Cancer
Key facts
- Where
- Clermont-Ferrand, Dijon, Grenoble Cedex 9, Le Mans, Lomme Cedex, Marseille, Metz Cedex 03, Nimes Cedex 9, Paris, Paris Cedex 18, Saint-Herblain Cedex, Strasbourg, Toulouse Cedex 9, Vandoeuvre Les Nancy és Villejuif Cedex, FranciaországSee the 15 sites
- Phase
- 3. fázis
Where in Franciaország
- Centre Jean PerrinClermont-Ferrand, FranciaországNo longer taking part
- Centr Georges Francois LeclercDijon, FranciaországNo longer taking part
- Centre Hospitalier Universitaire Grenoble AlpesGrenoble Cedex 9, FranciaországNo longer taking part
- Clinique Victor HugoLe Mans, FranciaországNo longer taking part
- Groupement Des Hopitaux De L'Institut Catholique De LilleLomme Cedex, FranciaországNo longer taking part
- Institut Paoli-CalmettesMarseille, FranciaországNo longer taking part
- Centre Hospital Region Metz ThionvilleMetz Cedex 03, FranciaországNo longer taking part
- Centre Hospitalier Universitaire De NimesNimes Cedex 9, FranciaországNo longer taking part
- Assistance Publique Hopitaux de ParisParis, FranciaországNo longer taking part
- Assistance Publique Hopitaux De ParisParis Cedex 18, FranciaországNo longer taking part
- Institut De Cancerologie De L OuestSaint-Herblain Cedex, FranciaországNo longer taking part
- Institut de Cancérologie Strasbourg EuropeStrasbourg, FranciaországNo longer taking part
- Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9, FranciaországNo longer taking part
- CHRU De NancyVandoeuvre Les Nancy, FranciaországNo longer taking part
- Institut Gustave RoussyVillejuif Cedex, FranciaországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Curium US LLC
- Trial code
- EU 2024-512754-16-01
- Record updated
- 2025. január 20.
- Original description
Primary Objective and Endpoints To determine the diagnostic performance of copper Cu 64 PSMA I&T PET/CT for the detection of presence or absence of pelvic lymph node metastasis in pre-prostatectomy patients with unfavorable intermediate-risk, high-risk or very high-risk PC.Read full original descriptionShow less
A Phase 3, Multicenter, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging of Men with Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy with Pelvic Lymph Node Dissection
Primary Objective and Endpoints To determine the diagnostic performance of copper Cu 64 PSMA I&T PET/CT for the detection of presence or absence of pelvic lymph node metastasis in pre-prostatectomy patients with unfavorable intermediate-risk, high-risk or very high-risk PC.
Inclusion: Patients with histologically proven prostate adenocarcinoma; Planned prostatectomy with pelvic lymph node dissection; Unfavorable intermediate-risk, high-risk, or very high-risk disease defined by NCCN Guidelines Version 1.2023 and previous versions; Male aged ≥18 years; Able to understand and provide signed written informed consent.
Exclusion: Androgen deprivation therapy, neoadjuvant chemotherapy, radiation therapy (including local ablation techniques), or any investigational therapy against PC prior to prostatectomy; Patients participating in an interventional clinical trial within 30 days and having received an IP within five (5) biological half-lives prior to administration; Patients with any medical condition or circumstance (including receiving an IP or capable of having a PET study) that the investigator believes may compromise the data collected or lead to a failure to fulfil the study requirements; Patients who are planned to have an x-ray contrast within 24 hours or other PET radiotracer < within 10 physical half-lives prior to the PET scan. If Barium contrast is administered this should be cleared before the PET scan; Patients who are administered any high energy (>300 KeV) gamma emitting radioisotopes within five (5) physical half-lives prior to copper Cu 64 PSMA I&T administration; Patients who had a PSMA PET as part of their standard medical care within 90 days prior to enrollment; Patients with known hypersensitivity to the active substance or any of the excipients of the IP.