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

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: Prostate Cancer; Prostate Cancer Recurrent
• Intervention / Treatment: Drug: [18F]PSMA-1007

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands
    • RUMC
• Switzerland
  • Bern, Switzerland
    • Inselspital, Universitätsspital
• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
    • Houston, Texas, United States, 77042
      • Excel Diagnostics and Nuclear Oncology Center
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [18F]PSMA-1007; single intravenous administration of [18F]PSMA-1007 for Positron Emission Tomography (PET) scan	Drug: [18F]PSMA-1007; diagnostic radiopharmaceutical for PET scan

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)	Within 6 months after PET/CT
Patient-level correct detection rate of [18F]PSMA-1007	Within 6 months after PET/CT

Collaborators and Investigators

• Sponsor: ABX advanced biochemical compounds GmbH

Study record dates

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: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• 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