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

NCT04742361 | Completed Phase 3 FDA Drug

• 1 other identifier: ABX-CT-303
• Study Type: interventional
• Target: 136
• Locations: 3 countries
• Sites: 6

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

[18F]PSMA-1007

EXPERIMENTAL

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

Drug: [18F]PSMA-1007

Interventions

[18F]PSMA-1007 DRUG

diagnostic radiopharmaceutical for PET scan

[18F]PSMA-1007

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ABX advanced biochemical compounds GmbH: lead

Study Sites (6)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Excel Diagnostics and Nuclear Oncology Center

Houston, Texas, 77042, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

RUMC

Nijmegen, Netherlands

Location

Inselspital, Universitätsspital

Bern, Switzerland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 8, 2021
• Study Start: August 27, 2021
• Primary Completion: June 23, 2023
• Study Completion: May 5, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); CH (1); US (4)