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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Prostate Cancer, Prostate Cancer Recurrent

Intervention / Treatment
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* Drug: [18F]PSMA-1007


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [18F]PSMA-1007<br>single intravenous administration of [18F]PSMA-1007 for Positron Emission Tomography (PET) scan | Drug: [18F]PSMA-1007<br>* diagnostic radiopharmaceutical for PET scan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |