Patient with Prostate Adenocarcinoma in biological relapse or in biological recurrent disease
Conditions
Interventions
Trade Name: Firmagon
Pharmaceutical Form: Solution for injection
Sponsors
Centre Léon Bérard
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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 450 msecs according to Bazett formula; E5. Impossibility to comply with the study follow-up for geographical, social or psychic reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the potentiating effect of androgen blockade on PET-PSMA uptake of prostate adenocarcinoma lesions;Secondary Objective: • To study the reproducibility of the interpretation of initial PET-PSMA and H-PSMA PET. • To evaluate the impact of androgen blockade on foci revealed by H-PSMA-PET compared to initial PET-PSMA-PET; •To evaluate the impact of initial PET-PSMA and PET-PSMA-H on changes in therapeutic management modalities; •To evaluate the value of late pelvic acquisition; •To study the correlation between the results of each PET-PSMA scan with clinical, histological data of the primary tumour and biological data of recurrence (PSA kinetics and velocity evaluated from the data available at the time of screening); • To study the correlation between changes in PSA and testosterone levels (between D0 and D14) and the results of the PET-PSMA scans; •To evaluate the tolerance profile. ;Primary end point(s): Comparison of the proportion of patients with positive PET in initial PET-PSMA (before androgen blockade) and H-PSMA-PET (=H-PSMA-PET after androgen blockade), patient being his own control.;Timepoint(s) of evaluation of this end point: Inclusion (before the androgen blockade) and Day 14 after the androgen blockade] | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Study of the inter-observer reproducibility of the interpretation of initial PET-PSMA and H-PSMA-PET on standard and late pelvic acquisitions. • Variation in the number of lesions and intensity of uptake (delta-SUVmax) of foci considered benign or suspicious according to interpretation guidelines between initial PET-PSMA and H-PSMA-PET. - Frequency and type of therapeutic management changes based on management questionnaires completed by two radiotherapists, separately, before and after PET-PSMA scans, but not knowing whether it was initial PET-PSMA or PET-PSMA-H. - Variation in the number of lesions and intensity of uptake (delta-SUVmax) of foci considered benign or suspicious according to interpretation guidelines, visualized on pelvic acquisition images at 3 hours of the 68Ga-PSMA injection compared to images at 1 hour on the same region of interest, for initial PET-PSMA and for H-PSMA-PET. - Correlation between the number of foci considered suspicious on each PET-PSMA scan and the clinical, histological data of the primary tumour and biological data of the recurrence (PSA kinetics and velocity calculated on https://www.mskcc.org/nomograms/prostate/psa_doubling_time). - Correlation of changes in PSA and testosterone levels with changes in the number and intensity of uptake of foci considered benign or suspicious between the two PET scans. - Toxicities evaluated according to the NCI-CTCAE v5 classification. Ancillary Study end point : -If the indication for external radiotherapy is maintained, evaluation of the variation in the number of lymph node areas and the overall volume to be irradiated between the two PET scans based initially only on the imaging results. This study will cover all the patients in the study and will be carried out by a nuclear physician and a Centre Léon Bérard radiotherapist. ;Timepoint(s) of evaluation of this end point: For all end points except toxicities : 1st PET-PSMA before androgen blockade a | — |
Countries
France
Contacts
Public ContactMédecine nucléaire
Centre Léon Bérard
Outcome results
None listed