PREFAcE : Interest of PET-PSMA imaging potentiated by androgen blockade in patients with biological relapse or persistent biological disease of a localized prostatic adenocarcinoma after initial treatment - PREFAcE

Centre Léon Bérard0 个研究点目标入组 52 人开始时间: 2019年12月20日最近更新: 2020年9月21日

试验速览

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•I1. Age = 18 years old;
•I2. Hormone-naive patients, initially treated curatively by prostatectomy for prostate adenocarcinoma and having a first or new biological recurrence (PSA greater than 0.2 ng/ml; confirmed on two samples one week apart) OR Hormone-naive patients, initially treated curatively by external radiotherapy for prostate adenocarcinoma and having a biological recurrence (PSA Nadir + 2ng/ml ; confirmed in two samples one week apart) OR hormone-naive patients treated by surgery or external radiotherapy for prostate adenocarcinoma but with persistent biological disease (PSA detectable after prostatectomy, or unchanged or increasing PSA after external radiotherapy);
•I3. Diagnostic recurrence assessment by pelvic MRI revealing no lesion, or having revealed local recurrence or ganglion lesions which may be due to external irradiation
•I4. Signed informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 22

•E1. Patient already treated by hormonotherapy;
•E2.Formal contraindication to hormonotherapy;
•E3. Formal contraindication to radiation therapy;
•E3. Formal contraindication to the Lasilix administration planned during the PET exams: Hypersensitivity to Furosemide or to one of the excipients, functional acute renal insufficiency, hepatic encephalopathy, urinary tracts obstruction, hypovolemia or dehydration, severe hypokalemia, severe hyponatremia, hepatitis in evolution and severe hepatocellular insufficiency in haemodialysis and severe renal insufficiency (creatinine clearance <30 ml / min) due to the risk of accumulation of furosemide, which is then mainly eliminated by the biliary route;
•E4.Significant cardiovascular affection such as myocardial infarction within the last 6 months preceding inclusion, severe rhythm disturbances, stroke within 6 months prior to inclusion, prolonged corrected QT interval with QTc > 450 msecs according to Bazett formula;
•E5. Impossibility to comply with the study follow-up for geographical, social or psychic reasons.

发起方

Centre Léon Bérard