Prostate cancer MedDRA version: 21.0 Level: PT Classification code 10036911 Term: Prostate cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10007453 Term: Carcinoma of the prostate metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10007454 Term: Carcinoma of the pro
Conditions
Interventions
Product Name: 68Ga-complex of Glu-NH-CO-NH-Lys-(Ahx)-HBED-CC
Product Code: [68GaPSMA-11]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: 68Ga-complex of Glu-NH-CO-NH-Lys-(Ahx)-HBED-CC
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Related to PCa: 1. Histologically documented castration resistant PCa treated with radical prostatectomy or loco-regional EBRT. 2. BCR PCa demonstrated by two consecutive PSA determinations 3. Life expectancy of more than 6 months. Related to the patient: 4. Male patients aged >18 years without upper age limit. 5. Ability to understand and willingness to sign a written informed consent document. 6. Written informed consent obtained according to international guidelines and local laws. 7. Compliant to the study procedures, based on the Investigator point of view. 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 61 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 185
Exclusion criteria
Exclusion criteria: Related to the PCa 1. Other malignancies Related to the patient: 1. Patient not willing to sign a written informed consent document. 2. Patient with severe chronic renal disease (according to the KDOQI/CTCAE eGFR or CrCl< 15 ml/min/1.73m2).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the changes induced by the use of [68Ga]PSMA-11 PET/CT in restaging and in treatment decision making of patients with biochemical failure PCa by comparing the diagnostic performances of [68Ga]PSMA-11 PET/CT (arm A) to the standard approach of [18F]FMCH PET/CT (arm B) at different PSA levels (PSA level of 0.2-0.5; 0.51-1;1.1-2; 2.1-6 ng/mL).;Secondary Objective: 1.To define the clinical outcomes of patients with oligometastatic PCa (up to 3 active synchronous metastasis) treated with [68Ga]PSMA-11 PET/CT and [18F]FMCH PET/CT-guided SBRT. 2.To identify new biomarkers to advance the understanding of oligometastatic PCa: a.Exosomes as novel intercellular communication vehicles in prostate cancer biology b.imaging biomarkers by Radiomics Advanced analysis (Radiomics) of the MRI images, [68Ga]PSMA-11 PET/CT and [18F]FMCH PET/CT images in patients with oligometastatic (up to 3 active synchronous metastasis) and multimetastatic disease (more than 3 synchronous metastasis). 3.To create an advanced normogram for oligometastatic patients.;Primary end point(s): Rate of positive patients, at different PSA levels (PSA level of 0.2-0.5; 0.51-1;1.1-2; 2.1-6 ng/mL), with oligometastatic and plurimetastatic disease in [68Ga]PSMA-11 PET/CT group as compared to [18F]FMCH PET/CT group.;Timepoint(s) of evaluation of this end point: 0 (endpoint is evaluated at the same time as the IMP administration since it is a diagnostic radiopharmaceutical for PET/CT imaging) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. PSA control (defined as Delta PSA = the decline between baseline PSA pre-SBRT and PSA value 6 weeks after treatment (¿PSA)), OS and DFS (estimated by the Kaplan-Meier method) of patients with oligometastatic PCa up to (up to 3 active synchronous metastasis) treated with [68Ga]PSMA-11 PET/CT and [18F]FMCH PET/CT-guided SBRT at 1 year of FU. In addition, biochemical progression-free survival, distant progression-free survival, local control, time to next intervention, ADT-free survival will be evaluated.; 2. Identification of circulating exosomes related mRNA in PCa recurrence in oligometastatic and multimetastatic patients as prognostic biomarkers (Kaplan–Meier plots, log-rank test to assess patient prognosis; Multivariate Cox proportional hazards regression analysis to evaluate independent prognostic factors associated with survival, and gene signature, metastatic tumor stage, and pathologic characteristics as covariates).; 3. Identification of the texture signature of the MRI images, [68Ga]PSMA-11 PET/CT and [18F]FMCH PET/CT images in patients with oligometastatic (up to 3 active synchronous metastasis) and multimetastatic disease (more than 3 synchronous metastasis).; 4. Selection of the variables for the advanced normogram, based on the previous statistical analysis. .;Timepoint(s) of evaluation of this end point: 1 year; After the end of radiotherapy (6 weeks after SBRT, three months after the end of external beam radiotherapy) or at the first evaluation after the beginning of systemic therapy (3 months after the beginning of systemic therapy).; 0 (endpoint is evaluated at the same time as the IMP administration since it is a diagnostic radiopharmaceutical for PET/CT imaging); 0 (endpoint is evaluated at the same time as the IMP administration since it is a diagnostic radiopharmaceutical for PET/CT imaging) | — |
Countries
Italy
Contacts
Public ContactNuclear Medicine Regional Center
Azienda Ospedaliero-Universitaria Pisana
Outcome results
None listed