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)

Central Hospital, Nancy, France

Status

Unknown

Conditions

Bone Metastasis

Treatments

Procedure: Sodium fluoride PET

Study type

Interventional

Funder types

Other

Identifiers

NCT02876991

2015-A00021-48

Details and patient eligibility

About

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.

Enrollment

110 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)