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ACTIVE NOT RECRUITING
NCT05622162
PHASE3

Prospective Comparative Study for Patients With Biochemical Recurrence Prostate Cancer Detecting by 18F-JK-PSMA-7

Sponsor: ITEL Telecomunicazioni Srl

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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