PSMA and C-11 Choline PET in Patients With Biochemical Recurrence of Prostate Cancer

Study Overview
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Brief Summary
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Imaging and staging of prostate cancer is critical for surgical and treatment planning. In this protocol we will image patients with suspected metastatic prostate cancer using 11C-Choline PET and Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) or F-18 labeled PSMA 1007 in order to demonstrate their utility in detecting prostate cancer.

Official Title
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PSMA and C-11 Choline PET in Patients With Biochemical Recurrence of Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Ga-68 PSMA11
* Drug: F-18 PSMA 1007


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histopathological proven prostate adenocarcinoma. Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy). a. Post radical prostatectomy (RP) - with or without radiation. i. PSA greater than or equal to 0.2 ng/mL measured more than 12 weeks after RP. ii. > 3 months post-surgery b. Post-radiation therapy ASTRO-Phoenix consensus definition c. May or may not be castrate resistant (list prior therapies) Karnofsky performance status of 50 (or ECOG/WHO equivalent). CT or as part of the PET study or performed within one month of PSMA PET. Age > 18. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: Undergoing investigational therapy for prostate cancer. Other ongoing treatments for prostate cancer including radiation therapy, chemotherapy or androgen deprivation. Androgen deprivation within the last 4 months excluding finasteride, dutasteride or other 5 alpha reductase inhibitors (excluding castrate resistant subjects). Unable to lie flat, still or tolerate a PET scan. Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer. Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device). Absence of PSA and total testosterone tests within 4 weeks.

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET/CT Ga-68 PSMA<br>Ga-68 labeled PSMA-11 (or PSMA-HBED-CC) PET/CT | Drug: Ga-68 PSMA11<br>* Ga-68 PSMA11 PET/CT for detection of tumor location<br>|
| Experimental: PET/CT F-18 Labeled PSMA 1007<br>F-18 Labeled PSMA 1007 PET/CT | Drug: F-18 PSMA 1007<br>* F-18 PSMA 1007 PET/CT for detection of tumor location<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Detection on PET/CT | Positive predictive value on a per-patient and per-region-basis of PSMA and C-11 choline PET/CT for detection of tumor location confirmed by histopathology/biopsy or conventional imaging follow-up. | 12 Months post PET/CT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of PSMA and C-11 choline PET on clinical management | Descriptive statistics will be used to evaluate the impact of PSMA and C-11 choline PET on clinical management | 12 Months | 
| Incidence of adverse events attributable to PSMA | Adverse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0) | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, PET/CT, PSMA, C-11 Choline