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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate-specific Membrane Antigen; mCRPC or Advanced/Metastatic Solid Tumors
• Intervention / Treatment: Drug: 68Ga-PSMA

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.

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oriana Nanni; Phone Number: +390543739266; Email: oriana.nanni@irst.emr.it

Study Locations

• Italy
  • FC
    • Meldola, FC, Italy, 47014
      • Recruiting
      • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
      • Contact: Paola Caroli, MD; Phone Number: 0543739100; Email: paola.caroli@irst.emr.it
      • Sub-Investigator: Federica Matteucci, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 68Ga-PSMA	Drug: 68Ga-PSMA; 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).

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

Collaborators and Investigators

• Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Investigators: Study Chair: Paola Caroli, MD, Irst Irccs

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2017
• Primary Completion (Estimated): July 1, 2023
• Study Completion (Estimated): July 1, 2023

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): March 5, 2018

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Prostate-specific membrane antigen; mCRPC or advanced/metastatic solid tumors
• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Gallium 68 PSMA-11
• Other Study ID Numbers: IRST100.34

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No