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

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Status: Enrolling

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

Treatments: Drug: 68Ga-PSMA

Study type: Interventional

Funder types: Other

Identifiers

NCT03453528

IRST100.34

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,200 participants in 1 patient group

68Ga-PSMA

Experimental group

Description:

68Ga-PSMA

Treatment:

Drug: 68Ga-PSMA