Prostate Adenocarcinoma Clinical Trial
— PREFAcEOfficial title:
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
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
Status | Recruiting |
Enrollment | 52 |
Est. completion date | March 14, 2024 |
Est. primary completion date | March 29, 2023 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 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) |
Country | Name | City | State |
---|---|---|---|
France | Centre Jean Perrin | Clermont-Ferrand | |
France | Chu Gabriel Montpied | Clermont-Ferrand | |
France | Centre Hospitalier de Grenoble Hôpital Nord Michallon | La Tronche | |
France | Centre Léon Bérard | Lyon | |
France | APHM - Hôpital Nord | Marseille | |
France | Centre Hospitalier Lyon Sud | Pierre-Bénite |
Lead Sponsor | Collaborator |
---|---|
Centre Leon Berard |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | In case of envisaged irradiation, impact on the modifications of irradiation volumes between the initial PET-PSMA and the PET-PSMA-H | PET-PSMA and PET-PSMA-H | Day 14 after the androgenic blockade | |
Primary | Comparison of the proportion of patients presenting a positive PET during the initial PSMA-PET (prior to androgenic blockade) and the PSMA-H-PET (PSMA PET after androgenic blockade), patient being his own witness | PSMA-PET | Day 14 after the androgenic blockade | |
Secondary | Evaluation of the reproductibility of the PSMA-PET and PSMA-H-PET interpretation | PSMA-PET and PSMA-H-PET | Day 14 after the androgenic blockade | |
Secondary | Evaluation of the impact of androgenic blockade on lesions revealed by PSMA-H PET in comparison with the initial PSMA-PET | Number of lesions (PSMA-ET and PSMA-H PET) | Day 14 after the androgenic blockade | |
Secondary | Evaluation of the impact of androgenic blockade on lesions revealed by PSMA-H PET in comparison with the initial PSMA-PET | Fixation intensity (PSMA-ET and PSMA-H PET) | Day 14 after the androgenic blockade | |
Secondary | Evaluation of the PSMA-PET and PSMA-H PET impact in the therapeutic management modifications | Comparison between treatments planned after PSMA-PET and treatments planned after PSMA-H-PET | Day 14 after the androgenic blockade | |
Secondary | Evaluation of the interest of late pelvic acquisition 3 hours after the PSMA-68Ga injection | PSMA-PET and PSMA-H-PET efficience | Day 14 after the androgenic blockade | |
Secondary | Evaluation of the results correlation of each PSMA-PET with clinical data, histologic primary tumor and biologic data of the recurrence (PSA kinetic and velocity assessed at screening) | PSMA-PET efficience | Day 14 after the androgenic blockade | |
Secondary | Evaluation of the results correlation of each PSMA-PET with clinical data, histologic primary tumor and biologic data of the recurrence (PSA kinetic and velocity assessed at screening) | PSA rate | Day 14 after the androgenic blockade | |
Secondary | Evaluation of the correlation between the PSA and testosterone rates variations between D0 and D14 and the PSMA-PET results | PSA and testosterone rates and PSMA-PET results | Day 14 after the androgenic blockade | |
Secondary | Tolerance profile | Incidence of PSMA-H-PET Adverse Events assessed by the Common Terminology Criteria for Adverse Events (CTCAE version 5.0) | Up to Day 15-30 visit |
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