F-18-PSMA-1007 Versus F-18-Fluorocholine PET in Patients With Biochemical Recurrence

Study Overview
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Brief Summary
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This study evaluates the diagnostic performance and safety of F-18-PSMA-1007 and F-18-Fluorocholine 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 F-18-PSMA-1007 vs F-18-Fluorocholine PET to Compare the Detection Rate 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: F-18-PSMA-1007
* Drug: F-18-Fluorocholine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male with original diagnosis of prostate carcinoma with prior definitive therapy suspicion of recurrence (3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir after radiotherapy or cryotherapy and/or PSA rise by greater than 0.2 ng/mL after prostatectomy) life expectancy of 6 months or more as judged by the investigator willing and able to undergo all study procedures informed consent in writing (dated and signed) Exclusion Criteria: age: less than18 years contraindications for F-18-Fluorocholine contraindications for any of the ingredients of F-18-PSMA-1007 close affiliation with the investigational site; e.g. first-degree relative of the investigator 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 being considered a vulnerable person

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: F-18-PSMA-1007<br>Patients will receive F-18-PSMA-1007 PET/CT first, followed by F-18-Fluorocholine PET/CT. | Drug: F-18-PSMA-1007<br>* Patients will receive F-18-PSMA-1007 PET/CT and F-18-Fluorocholine PET/CT in randomized order.<br>Drug: F-18-Fluorocholine<br>* Patients will receive F-18-PSMA-1007 PET/CT and F-18-Fluorocholine PET/CT in randomized order.<br>|
| Active Comparator: F-18-Fluorocholine<br>Patients will receive F-18-Fluorocholine PET/CT first, followed by F-18-PSMA-1007 PET/CT. | Drug: F-18-PSMA-1007<br>* Patients will receive F-18-PSMA-1007 PET/CT and F-18-Fluorocholine PET/CT in randomized order.<br>Drug: F-18-Fluorocholine<br>* Patients will receive F-18-PSMA-1007 PET/CT and F-18-Fluorocholine PET/CT in randomized order.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare detection rate of metastatic prostate cancer lesions of F-18-PSMA-1007 versus F-18-Fluorocholine |  | Within 6 months after PET/CT |