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

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS1,225 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

1,225

Conditions

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

Interventions

68Ga-PSMADRUG

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with mCRPC or advanced/metastatic solid tumors; 2. Male or Female, aged \>18 years; 3. Written informed consent; 4. Relapse or progression of disease on CT scan and / or MRI; 5. 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. 6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Exclusion Criteria: 1. Pregnancy / Nursing; 2. Participation in another clinical trial with any investigational agents within 30 days prior to study entry 3. Medical or psychological conditions that would not allow the participant to understand, or sign the informed consent. 4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga-PSMA or other agents used in the study. 5. inability to remain still for the entire duration of the exam

Locations (1)

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

Meldola, FC, Italy

Outcomes

Primary Outcomes

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).

Time frame: up to 36 months

Secondary Outcomes

Safety is defined as the number and percentage of treated patients undergoing grade 1 to 4 adverse events according to CTCAE version 4.03

Time frame: 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;

Time frame: 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;

Time frame: 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.

Time frame: up to 36 months

Data from ClinicalTrials.gov

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