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
- Bone Metastasis
- Interventions
- Procedure: Sodium fluoride PET
- Registration Number
- NCT02876991
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 110
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sodium fluoride PET Sodium fluoride PET Before inclusion, patients undergo choline PET to assess an occult recurrence of prostate cancer. After inclusion, they undergo sodium fluoride PET.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Inter-strategy concordance of diagnosis evaluated by kappa coefficient 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 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)
Trial Locations
- Locations (1)
Service de Médecine Nucléaire CHRU de Nancy-Brabois
🇫🇷Vandœuvre-lès-Nancy, France