Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer

NCT ID: NCT04742361

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-27
• Study Completion Date: 2025-05-05

Brief Summary

This study evaluates the diagnostic performance and safety of [18F]PSMA-1007 PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.

Conditions

Prostate Cancer; Prostate Cancer Recurrent

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

[18F]PSMA-1007

single intravenous administration of \[18F\]PSMA-1007 for Positron Emission Tomography (PET) scan

Group Type: EXPERIMENTAL

[18F]PSMA-1007

Intervention Type: DRUG

diagnostic radiopharmaceutical for PET scan

Interventions

[18F]PSMA-1007

diagnostic radiopharmaceutical for PET scan

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male with original diagnosis of adenocarcinoma of the prostate with prior definitive therapy
• Suspicion of recurrence or persistence

• after radiotherapy or cryotherapy: 3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir (ASTRO-Phoenix)
• after prostatectomy, PSA > 0.2 ng/mL on 2 or more determinations (recurrence), or failure of PSA to fall to undetectable levels post-prostatectomy (persistence) (American Urological Association)
• For patients who previously had radical prostatectomy, salvage radiotherapy is one likely treatment plan; for patients who initially underwent radiotherapy (including brachytherapy), confirmation of low volume disease is needed to define (local) treatment.
• Life expectancy of 6 months or more as judged by the investigator
• Willing and able to undergo all study procedures
• Informed consent in writing

Exclusion Criteria

• Age: less than18 years
• Contraindications to any of the ingredients of [18F]PSMA-1007
• Close affiliation with the investigational site
• At the time of enrolment into this study, participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial
• Having been previously enrolled in this clinical trial
• Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
• Being clinically unstable or requiring emergency treatment
• Patients who are unwilling to consider a biopsy if clinically recommended
• Patients who are unable to undergo a PET/CT scan
• Patients for whom systemic therapy is the most likely course regardless of PET findings.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

ABX advanced biochemical compounds GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mayo Clinic

Rochester, Minnesota, United States

MD Anderson Cancer Center

Houston, Texas, United States

Excel Diagnostics and Nuclear Oncology Center

Houston, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

RUMC

Nijmegen, , Netherlands

Inselspital, Universitätsspital

Bern, , Switzerland

Countries

United States; Netherlands; Switzerland

Other Identifiers

ABX-CT-303

Identifier Type: -

Identifier Source: org_study_id