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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04742361
• Other study ID #: ABX-CT-303
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 8, 2021
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: ABX advanced biochemical compounds GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 136
• Est. completion date: June 2024
• Est. primary completion date: June 23, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostate Cancer Recurrent
• Prostatic Neoplasms

Intervention

Drug:
• [18F]PSMA-1007
diagnostic radiopharmaceutical for PET scan

Locations

Country	Name	City	State
Netherlands	RUMC	Nijmegen
Switzerland	Inselspital, Universitätsspital	Bern
United States	Excel Diagnostics and Nuclear Oncology Center	Houston	Texas
United States	MD Anderson Cancer Center	Houston	Texas
United States	Mayo Clinic	Rochester	Minnesota
United States	Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
ABX advanced biochemical compounds GmbH

Countries where clinical trial is conducted

United States,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Region-level positive predictive value (PPV) of [18F]PSMA-1007 using a combined standard of truth (SOT)		Within 6 months after PET/CT
Primary	Patient-level correct detection rate of [18F]PSMA-1007		Within 6 months after PET/CT