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

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Unknown status

CT.gov ID

NCT02876991

Collaborator

(none)

110

Enrollment

Location

Arm

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Metastasis	Procedure: Sodium fluoride PET	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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 Start Date :

Feb 1, 2016

Anticipated Primary Completion Date :

Aug 1, 2018

Anticipated Study Completion Date :

Feb 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.	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.

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

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

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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)