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Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT04742361•ABX advanced biochemical compounds GmbH

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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.

Locations (6)

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

Key Dates

Start Date

August 27, 2021

Primary Completion Date

June 23, 2023

Completion Date

May 5, 2025

Last Updated

July 15, 2025

Enrollment

136

ACTUAL participants

Conditions

Prostate CancerProstate Cancer Recurrent

Interventions

[18F]PSMA-1007

DRUG

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

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RECRUITINGPHASE2

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC