Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
July 10, 2025 updated by: ABX advanced biochemical compounds GmbH
Phase III Study of [18F]PSMA-1007 Positron Emission Tomography for the Detection of Prostate Cancer Lesions in Patients With Biochemical Recurrence After Previous Definitive Treatment for Localized Prostate Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
136
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nijmegen, Netherlands
- RUMC
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Bern, Switzerland
- Inselspital, Universitätsspital
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Texas
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
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Houston, Texas, United States, 77042
- Excel Diagnostics and Nuclear Oncology Center
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Utah
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Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: [18F]PSMA-1007
single intravenous administration of [18F]PSMA-1007 for Positron Emission Tomography (PET) scan
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diagnostic radiopharmaceutical for PET scan
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Region-level positive predictive value (PPV) of [18F]PSMA-1007 using a combined standard of truth (SOT)
Time Frame: Within 6 months after PET/CT
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Within 6 months after PET/CT
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Patient-level correct detection rate of [18F]PSMA-1007
Time Frame: Within 6 months after PET/CT
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Within 6 months after PET/CT
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 27, 2021
Primary Completion (Actual)
June 23, 2023
Study Completion (Actual)
May 5, 2025
Study Registration Dates
First Submitted
February 3, 2021
First Submitted That Met QC Criteria
February 4, 2021
First Posted (Actual)
February 8, 2021
Study Record Updates
Last Update Posted (Actual)
July 15, 2025
Last Update Submitted That Met QC Criteria
July 10, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABX-CT-303
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.