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Prospective Comparative Study for Patients With Biochemical Recurrence Prostate Cancer Detecting by 18F-JK-PSMA-7
Sponsor: ITEL Telecomunicazioni Srl
Summary
The present study in patients with Prostate cancer and biochemical failure after surgery and/or radical-postoperative Radio Therapy (RT) will evaluate if PET/CT with 18F-JK-PSMA-7 compared to PET-CT 18F-Choline is able to identify the early pattern of biochemical recurrence and/or metastatic sites, so that the patient could be better managed, with a benefit in survival.
Official title: Phase III Multicentre Prospective Comparative Study of Detection Rate of 18F-JK-PSMA-7 and of 18F-fluorocholine in Patients With Biochemical Recurrence of Prostate Cancer After Previous Treatment With Curative Intent
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
106
Start Date
2022-12-19
Completion Date
2024-06
Last Updated
2024-05-22
Healthy Volunteers
No
Interventions
Radiopharmaceutical 18F-JK-PSMA-7
The Investigational product 18F-JK-PSMA-7 is a diagnostic radiopharmaceutical for use with positron emission tomography. 18F-JK-PSMA-7 is administered as direct intravenous injection. One single administration of 2-4 MBq/kg of 18F-JK-PSMA-7 is scheduled in each patient included in this study.
Radiopharmaceutical 18F-Fluorocholine
The active substance of Comparator is 18F-Fluorocholine. The Comparator will be a 18F-Fluorocholine with a Marketing Authorisation in Italy that will be used in compliance with its Summary of Product Characteristics (SmPC). 18F-Fluorocholine is administrated as direct intravenous injection. One single administration of 18F-Fluorocholine is scheduled in each patient included in this study.
Locations (2)
I.R.S.T. Srl Irccs
Meldola, Forlì-Cesena, Italy
Ospedale Classificato Sacro Cuore - Don Calabria
Negrar, Verona, Italy