Evaluation of Sodium Fluoride PET in the Identification of Bone Metastases in Patients Having Undergone a Choline PET for Occult Recurrence of Prostatic Adenocarcinoma

Study Overview
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Brief Summary
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The purpose is to evaluate if sodium fluoride PET in patients having already undergone a choline PET negative for bone extension (non-metastatic status) modifies the status of patients concerning the existence or not of bone metastases. Secondary purposes are: To evaluate if detection of bone metastasis by sodium fluoride PET, not detected by choline PET, leads to change of treatment To evaluate inter-technique concordance (choline vs sodium fluoride PET) of results (metastatic status and number of lesions) To evaluate the inter-judge concordance of interpretation of sodium fluoride PET To study the discordance of metastatic status of 2 techniques.

Official Title
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Evaluation of Sodium Fluoride PET in the Identification of Bone Metastases in Patients Having Undergone a Choline PET for Occult Recurrence of Prostatic Adenocarcinoma

Conditions
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Bone Metastasis

Intervention / Treatment
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* Procedure: Sodium fluoride PET


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prostate adenocarcinoma regardless of Gleason score Patients having undergone radical treatment (prostatectomy or radiotherapy (external or brachytherapy) +/- conco-adjuvant hormonal therapy) Level of Prostate Specific Antigen (PSA) indicating recurrence: PSA > 0.2 ng/ml in case of prostatectomy (in 2 consecutive tests in less than 1 month) or elevation of PSA of at least 2 ng/ml above nadir in case of radiotherapy or brachytherapy (in 2 consecutive tests in less than 1 month) Negative conventional assessment (thoracic-abdominal-pelvic scanner and bone scintigraphy) during 6 weeks before inclusion Patient having undergone a choline PET at CHRU Nancy Signed informed consent Affiliation to French social security Absence of contraindications to sodium fluoride PET Exclusion Criteria: Refusal or impossibility of informed consent Patient incapable to consent Patient deprived of liberty Person under legal protection Person in life-and-death emergency Drug addiction, alcoholism, psychological problems affecting patient compliance Severe co-morbidities Modification of hormonal therapy (if applicable) during 3 months before inclusion Renal insufficiency (creatinine clearance < 60 ml/min) detected during last assessment before inclusion Other progressive tumors (recovered cancers are not a non-inclusion criteria)

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 |
| --- | --- |
| Other: Sodium fluoride PET<br>Before inclusion, patients undergo choline PET to assess an occult recurrence of prostate cancer. After inclusion, they undergo sodium fluoride PET. | Procedure: Sodium fluoride PET<br>* Sodium fluoride Pet is realized maximum after 4 weeks from choline PET (inclusion). Injection of 4MBq 18F-FNa/kg of body weight is followed after 60 min (± 5 min) by acquisition of images on Biograph 6 PET/CT scanner (SIEMENS). Data from sodium fluoride PET are interpreted independently and blind from other data by 3 medical doctors (2 at hospital of Nancy and 1 at hospital of Strasbourg) (for inter-judge reproducibility); a second interpretation of data is consensually realized by 2 of 3 readers, limited to discordant analyses (metastatic status or not, and/or number of lesions); results from this second interpretation are final results.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with choline PET negative and sodium fluoride PET positive for bone extension (metastasis) |  | Execution of sodium fluoride PET (up to 4 weeks from choline PET; from baseline up to 4 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-strategy concordance of diagnosis evaluated by kappa coefficient | Concordance between results of choline PET and sodium fluoride PET | Execution of sodium fluoride PET (up to 4 weeks from choline PET; from baseline up to 4 weeks) | 
| Metastatic status and number of lesions detected respectively by sodium fluoride PET and choline PET |  | Execution of sodium fluoride PET (up to 4 weeks from choline PET; from baseline up to 4 weeks) | 
| Metastatic status and number of lesions identified by 3 medical doctors of 2 different centres in sodium fluoride PET |  | Execution of sodium fluoride PET (from baseline up to 4 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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choline positron emission tomography, occult recurrence, prostatic adenocarcinoma, sodium fluoride positron emission tomography