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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04742361
Other study ID # ABX-CT-303
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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
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