Patients mCRPC eligible to treatment with 223RaCl2 MedDRA version: 21.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10005993 Term: Bone metastases System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.1 Level: LLT Classification code 10036223 Term: Posit
Conditions
Interventions
Product Name: 68-Ga-HBED-CC-PSMA
Product Code: [68Ga-PSMA]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PSMA-11
CAS Number: 1366302-52-4
Current Sponsor code: PSMA-11
Other descrip
Sponsors
AZIENDA USL DELLA VALLE D'AOSTA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Age>45 2.Ability to provide informed written consent. All subjects must sign an informed consent form indicating their understanding investigational nature of study 3.Histologically or cytologically confirmed adenocarcinoma of the prostate 4.Known hormone refractory disease (castrate serum testosterone level: =50 ng/dL) 5.Multiple skeletal metastases (= 2 hot spots) on bone scintigraphy within 4 weeks 6.Bone pain (Brief Pain Inventory BPI-SF = 2 ) 7.ECOG Performance status (PS): 0-2 8.Acceptable haematology and serum biochemistry screening values as follows: WBC= 3000/mm3 , ANC= 1500/mm3, PLT= 100000/mm3 , Hb= 10 g/dl, Total bilirubin = 2.0 mg/dL, ALT and AST = 2.5 x the upper limit of normal, Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1.Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc) or to complete the needed investigational due to others reasons (severe claustrophobia unresponsive to oral anxiolytics, radiation phobia, etc) 2.Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI 3.Visceral metastases assessed by thorax and abdominal/pelvic CT within previous 8 weeks 4.Malignant lymphoadenopathy exceeding 3 cm in short axis diameter assessed by thorax and abdominal/pelvic CT within previous 8 weeks 5.Patients with known inflammatory bowel disease (IBD) 6.Patients with known osteonecrosis of the jaw (ONJ) 7.Partecipation in another clinical trial with any investigational agents within 4 weeks prior to study screening or within five half-lives of the drug 8.Concomitant chemotherapy, abiraterone or enzalutamide therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -Response evaluation of patients treated with 223RaCl2 (Xofigo®, Bayer) using 68Ga-PSMA imaging PET; - Evaluate if PSMA-PET response can be used as a biomarker to predict survival in patients treated with 223RaCl2 (Xofigo®, Bayer).;Secondary Objective: - Comparison of PSMA-PET results with a validated imaging (bone scintigraphy); -Correlation of PSA and ALP changes with results of PSMA-PET; -Correlation of PSMA-PET response with time to first symptomatic skeletal event (SSE). ;Primary end point(s): Response evaluation of patients treated with 223RaCl2 (Xofigo®, Bayer) using 68Ga-PSMA imaging PET;;Timepoint(s) of evaluation of this end point: 20 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluate if PSMA-PET response can be used as a biomarker to predict survival in patients treated with 223RaCl2 (Xofigo®, Bayer);Timepoint(s) of evaluation of this end point: 30 months | — |
Countries
Italy
Contacts
Public ContactS.C. Medicina Nucleare
Azienda USL della Valle d'Aosta
Outcome results
None listed