Status:
COMPLETED
Interest of PET-PSMA Imaging Potentialised by Androgen Blockade in Localized Prostatic Adenocarcinoma
Lead Sponsor:
Centre Leon Berard
Conditions:
Prostate Adenocarcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 initi...
Detailed Description
The identification of lesions responsible for biological recurrence or persistent biological disease in patients with prostatic adenocarcinoma (PA) remains an outstanding problem due to the lack of se...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old;
- 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 at least two successive dosages in the last 12 months) OR Hormone-naive patients, initially treated curatively by external radiotherapy or by brachytherapy for prostate adenocarcinoma and having a biological recurrence (PSA Nadir + 2ng/ml ; confirmed on at least two successive dosages in the last 12 months ) OR hormone-naive patients treated by surgery or external radiotherapy or brachytherapy for prostate adenocarcinoma but with persistent biological disease (PSA detectable after prostatectomy, or unchanged or increasing PSA after external radiotherapy or brachytherapy);
- Diagnostic recurrence assessment by any information or examination carried out since the ascension of the PSA, not having revealed local recurrence or lymph node lesions which may benefit from to external radiation
- Signed informed consent.
Exclusion
- 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)
Key Trial Info
Start Date :
September 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2024
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04391556
Start Date
September 14 2020
End Date
April 3 2024
Last Update
August 14 2025
Active Locations (6)
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1
Chu Gabriel Montpied
Clermont-Ferrand, France, 63003
2
Centre Jean Perrin
Clermont-Ferrand, France, 63011
3
Centre Hospitalier de Grenoble Hôpital Nord Michallon
La Tronche, France, 38700
4
Centre Léon Bérard
Lyon, France, 69008