Informations générales (source: ClinicalTrials.gov)
Evaluation of Sodium Fluoride PET in the Identification of Bone Metastases in Patients Having Undergone a Choline PET for Occult Recurrence of Prostatic Adenocarcinoma (FNa-CHOLINE)
Interventional
N/A
Central Hospital, Nancy, France (Voir sur ClinicalTrials)
février 2016
février 2019
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Service de Médecine Nucléaire CHRU de Nancy-Brabois - Vandœuvre-lès-Nancy - France | Pierre OLIVIER, Pr | Contact (sur clinicalTrials) | |||
Critères
Homme
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
- 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)