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

NCT05622162 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2024-05-22

No results posted yet for this study

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.

Conditions

  • Prostate Cancer
  • 18F- Fluorocholine
  • PSMA PET
  • Radiotherapy
  • Prostatectomy
  • Tumor of Prostate

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.

Sponsors & Collaborators

  • Advice Pharma Group srl

    collaborator INDUSTRY

  • ITEL Telecomunicazioni Srl

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-19
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05622162 on ClinicalTrials.gov