Interest of PET-PSMA Imaging Potentialised by Androgen Blockade in Localized Prostatic Adenocarcinoma

• Status: Recruiting
• Trial end date: 2022-02-04
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of the 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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Leon Berard

Criteria

Inclusion Criteria:

• Age ≥ 18 years old;

• Hormonotherapy-naive patients initially treated by prostatectomy for prostate adenocarcinoma with biological recurrence (PSA greater than 0.2 ng / ml confirmed on two samples spaced one week apart), OR hormonotherapy-naive patients initially treated by external radiotherapy for prostate adenocarcinoma and presenting a biological recurrence (Nadir of PSA + 2, confirmed by at least two successive samples during the last 12 months) OR hormonotherapy-naïve patients naive treated by surgery or external radiotherapy for prostate adenocarcinoma but with persistent biological disease (detectable PSA after prostatectomy, or PSA unchanged or progressing after external radiotherapy);

• Diagnostic recurrence assessment by pelvic MRI or any other exam performed since the PSA increase revealing no lesion, or having revealed local recurrence or ganglion lesions which may be due to external irradiation

• Signed informed consent.

Exclusion Criteria:

• Patient already treated by hormonotherapy;

• Formal contraindication to hormonotherapy;

• Formal contraindication to external radiotherapy

• Formal contraindication to the Lasilix administration 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 patient and patient presenting a 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;

• 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;

• Impossibility to comply with the study follow-up for geographical or psychic reasons.

• Patient under protection of justice (Under tutorship, curatorship or deprived of liberty)