Investigation of PSMA PET/CT as an Imaging Biomarker in Solid Tumors

Study Overview
=================
Brief Summary
-----------------
multi-centre, prospective, diagnostic trial to evaluate the Prostate-Specific Membrane Antigen (PSMA-antigen) over-expression in metastatic castration resistant prostate cancer (mCRPC) and in advanced/metastatic solid tumors patients.

Detailed Description
-----------------
Multi-centre, prospective, diagnostic trial to evaluate the Prostate-Specific Membrane Antigen (PSMA-antigen) over-expression in metastatic castration resistant prostate cancer (mCRPC) and in advanced/metastatic solid tumors patients. The primary objective of this study is to evaluate the detection rate of PSMA PET/CT, defined as the ratio of PSMA-positive patients and the total number of cancer patients with known advanced/metastatic disease that performed a PSMA PET/CT as part of the present study. A positive patient is defined as a patient with at least one PSMA-positive lesion.

Official Title
-----------------
Investigation of PSMA PET/CT as an Imaging Biomarker in Solid Tumors

Conditions
-----------------
Prostate-specific Membrane Antigen, mCRPC or Advanced/Metastatic Solid Tumors

Intervention / Treatment
-----------------
* Drug: 68Ga-PSMA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with mCRPC or advanced/metastatic solid tumors; Male or Female, aged >18 years; Written informed consent; Relapse or progression of disease on CT scan and / or MRI; If female of childbearing potential, highly effective birth control methods according to guideline Recommendation related to contraception and pregnancy testing in clinical trials (2014_09_15 section 4.1) are mandatory, beginning at the screening visit and continuing until 6 months following last 68Ga-PSMA PET/CT. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Exclusion Criteria: Pregnancy / Nursing; Participation in another clinical trial with any investigational agents within 30 days prior to study entry Medical or psychological conditions that would not allow the participant to understand, or sign the informed consent. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga-PSMA or other agents used in the study. inability to remain still for the entire duration of the exam

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-PSMA<br>68Ga-PSMA | Drug: 68Ga-PSMA<br>* 68Ga-PSMA will be injected intravenously via an indwelling catheter in an antecubital vein; (68Ga-PSMA activity: min 100 MBq - max 200 MBq, weighted activity: 2.0 MBq/Kg).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection rate of 68Ga-PSMA PET/CT | the proportion of 68Ga-PSMA- positive patients and the total number of recruited patients in two groups population's (metastatic castration-resistance prostate cancer and various origin solid tumors). | up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety | Safety is defined as the number and percentage of treated patients undergoing grade 1 to 4 adverse events according to CTCAE version 4.03 | up to 36 months | 
| Lesion detection rate stratified per tumor histotypes | Proportion of positive patients on total number who underwent 68Ga-PSMA PET/CT stratified for tumor histotypes; | up to 36 months | 
| Lesion detection rate stratified for different lesion sites | Proportion of positive patients on total number who underwent 68Ga-PSMA PET/CT stratified for different lesion sites; | up to 36 months | 
| Changes in 68Ga-PSMA uptake in patients with other solid tumors who receive anti-angiogenetic therapies according to objective clinical response; | Changes in 68Ga-PSMA uptake in patients and correlation with clinical response to 177Lu-PSMA therapy for prostate cancer, or other angiogenic therapy. | up to 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mCRPC or advanced/metastatic solid tumors, Prostate-specific membrane antigen