Prostate Cancer, Prostate Cancer Recurrent
Conditions
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.
Interventions
DRUG[18F]PSMA-1007
diagnostic radiopharmaceutical for PET scan
Sponsors
ABX advanced biochemical compounds GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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 |
Countries
Netherlands, Switzerland, United States
Outcome results
None listed