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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2018

Interventions

  • Procedure: Sodium fluoride PET
    • 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.

Arms, Groups and Cohorts

  • Other: Sodium fluoride PET
    • Before inclusion, patients undergo choline PET to assess an occult recurrence of prostate cancer. After inclusion, they undergo sodium fluoride PET.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of patients with choline PET negative and sodium fluoride PET positive for bone extension (metastasis)
    • Time Frame: Execution of sodium fluoride PET (up to 4 weeks from choline PET; from baseline up to 4 weeks)

Secondary Measures

  • Inter-strategy concordance of diagnosis evaluated by kappa coefficient
    • Time Frame: Execution of sodium fluoride PET (up to 4 weeks from choline PET; from baseline up to 4 weeks)
    • Concordance between results of choline PET and sodium fluoride PET
  • Metastatic status and number of lesions detected respectively by sodium fluoride PET and choline PET
    • Time Frame: 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
    • Time Frame: Execution of sodium fluoride PET (from baseline up to 4 weeks)

Participating in This Clinical Trial

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 noninclusion criteria)

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Central Hospital, Nancy, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pierre OLIVIER, Pr, Principal Investigator, Service de Médecine Nucléaire – CHRU de Nancy-Brabois – Vandœuvre-lès-Nancy
  • Overall Contact(s)
    • Pierre OLIVIER, Pr, p.olivier@chru-nancy.fr

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