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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2019-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Bone Metastasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Sodium fluoride PET

Before inclusion, patients undergo choline PET to assess an occult recurrence of prostate cancer.

After inclusion, they undergo sodium fluoride PET.

Group Type OTHER

Sodium fluoride PET

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No