Clinical trial NCT04391556: Interest of PET-PSMA Imaging Potentialised by Androgen Blockade in Localized Prostatic Adenocarcinoma
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Adenocarcinoma
Keywords: Prostate adenocarcinoma
TEP PSMA
Androgenic blockade
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 57
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 initial treatment

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 sensitivity of standard imaging techniques. The efficacy of empirical radiation therapy of the prostate + pelvis zone in only half of patients with increased PSA suggests an underestimation of lesions.

PET-68Ga-PSMA or PET-PSMA technique showed a clear gain in sensitivity for the detection of lesions in this context compared to PET-Choline which was already more sensitive than standard imaging. It is about 50% for a PSA \<0.5 ng / ml vs 20% for a PSA \<1 ng / ml for TEP-Choline technique. However, the indication of empirical radiotherapy is raised when the PSA exceeds 0.2 ng / ml. It is therefore still necessary to increase the sensitivity of PET-PSMA.

A flare-up-related effect was observed in a small animal experiment and in a patient after androgen blocking treatment, inducing a sharp increase in the intensity of previously visualized lesions and the appearance of 13 new lesions.

It would therefore be possible to increase the expression of PSMA by the lesions at the origin of the biological recurrence of AP and thus to improve their detection by PET-PSMA after potentiation by short-term androgen blocking by an antagonist of LH-RH.

Eligibility criteria: 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)

Primary outcomes:
measure: 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
timeFrame: Day 14 after the androgenic blockade
Secondary outcomes:
measure: Evaluation of the reproductibility of the PSMA-PET and PSMA-H-PET interpretation
timeFrame: Day 14 after the androgenic blockade
measure: Evaluation of the impact of androgenic blockade on lesions revealed by PSMA-H PET in comparison with the initial PSMA-PET
timeFrame: Day 14 after the androgenic blockade
measure: Evaluation of the impact of androgenic blockade on lesions revealed by PSMA-H PET in comparison with the initial PSMA-PET
timeFrame: Day 14 after the androgenic blockade
measure: Evaluation of the PSMA-PET and PSMA-H PET impact in the therapeutic management modifications
timeFrame: Day 14 after the androgenic blockade
measure: Evaluation of the interest of late pelvic acquisition 3 hours after the PSMA-68Ga injection
timeFrame: Day 14 after the androgenic blockade
measure: 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)
timeFrame: Day 14 after the androgenic blockade
measure: 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)
timeFrame: Day 14 after the androgenic blockade
measure: Evaluation of the correlation between the PSA and testosterone rates variations between D0 and D14 and the PSMA-PET results
timeFrame: Day 14 after the androgenic blockade
measure: Tolerance profile
timeFrame: Up to Day 15-30 visit
Other outcomes:
measure: In case of envisaged irradiation, impact on the modifications of irradiation volumes between the initial PET-PSMA and the PET-PSMA-H
timeFrame: Day 14 after the androgenic blockade
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Gabriel Montpied
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: La Tronche
country: France
facility: Centre Hospitalier de Grenoble Hôpital Nord Michallon
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: APHM - Hôpital Nord
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
affiliation: Centre Leon Berard
name: Anne-Laure GIRAUDET, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Leon Berard
name: David KRYZA, MD
role: PRINCIPAL_INVESTIGATOR
References: