Response evaluation with 68Ga-PSMA PET of metastatic prostate cancer castration resistant patients in treatment with 223RaCl2

Phase 1

• Conditions: Patients mCRPC eligible to treatment with 223RaCl2; MedDRA version: 21.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10005993Term: Bone metastasesSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.1Level: LLTClassification code 10036223Term: Positron emission tomographySystem Organ Class: 100000004848; MedDRA version: 21.1Level: PTClassification code 10062904Term: Hormone-refractory prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-001395-38-IT
• Lead Sponsor: AZIENDA USL DELLA VALLE D'AOSTA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-05
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 50

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 <1.5 x the upper limit of normal
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: -Response evaluation of patients treated with 223RaCl2 (Xofigo®, Bayer) using 68Ga-PSMA imaging PET;<br>- 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); <br>-Correlation of PSA and ALP changes with results of PSMA-PET;<br>-Correlation of PSMA-PET response with time to first symptomatic skeletal event (SSE).<br>;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 Outcome Measures

Name	Time	Method
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