Clinical trial NCT02876991: Evaluation of Sodium Fluoride PET in the Identification of Bone Metastases in Patients Having Undergone a Choline PET for Occult Recurrence of Prostatic Adenocarcinoma
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Metastasis
Keywords: choline positron emission tomography
occult recurrence
prostatic adenocarcinoma
sodium fluoride positron emission tomography
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 110
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of patients with choline PET negative and sodium fluoride PET positive for bone extension (metastasis)
timeFrame: Execution of sodium fluoride PET (up to 4 weeks from choline PET; from baseline up to 4 weeks)
Secondary outcomes:
measure: Inter-strategy concordance of diagnosis evaluated by kappa coefficient
timeFrame: Execution of sodium fluoride PET (up to 4 weeks from choline PET; from baseline up to 4 weeks)
measure: Metastatic status and number of lesions detected respectively by sodium fluoride PET and choline PET
timeFrame: Execution of sodium fluoride PET (up to 4 weeks from choline PET; from baseline up to 4 weeks)
measure: Metastatic status and number of lesions identified by 3 medical doctors of 2 different centres in sodium fluoride PET
timeFrame: Execution of sodium fluoride PET (from baseline up to 4 weeks)
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Service de Médecine Nucléaire CHRU de Nancy-Brabois
Study officials:
affiliation: Service de Médecine Nucléaire - CHRU de Nancy-Brabois - Vandœuvre-lès-Nancy
name: Pierre OLIVIER, Pr
role: PRINCIPAL_INVESTIGATOR
References: