Interest of PET-PSMA Imaging potentialised by androgen blockade in localized prostatic adenocarcinoma in relapse or reccurent disease

Phase 1

• Conditions: Patient with Prostate Adenocarcinoma in biological relapse or in biological recurrent disease; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-003346-32-FR
• Lead Sponsor: Centre Léon Bérard

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-20
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 52

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified