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

Phase 3

Active, not recruiting

• Conditions: Prostate Cancer; Prostate Cancer Recurrent
• Interventions: Drug: [18F]PSMA-1007

• Registration Number: NCT04742361
• Lead Sponsor: ABX advanced biochemical compounds GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-08
• Study Start: 2021-09-08
• Primary Completion: 2024-01-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 136

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Excel Diagnostics and Nuclear Oncology Center; 🇺🇸 Houston, Texas, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

RUMC; 🇳🇱 Nijmegen, Netherlands

Inselspital, Universitätsspital; 🇨🇭 Bern, Switzerland

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States