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

NCT03453528 | Completed

• 1 other identifier: IRST100.34
• Study Type: interventional
• Target: 1,225
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

mCRPC or advanced/metastatic solid tumors; Prostate-specific membrane antigen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  up to 36 months

• Lesion detection rate 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;

  up to 36 months

Study Arms (1)

68Ga-PSMA

EXPERIMENTAL

68Ga-PSMA

Drug: 68Ga-PSMA

Interventions

68Ga-PSMA DRUG

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).

68Ga-PSMA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS: lead

Study Sites (1)

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

Meldola, FC, 47014, Italy

Location

MeSH Terms

Interventions

gallium 68 PSMA-11

Study Officials

• Paola Caroli, MD

  IRST IRCCS

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 5, 2018
• Study Start: July 4, 2017
• Primary Completion: December 4, 2024
• Study Completion: January 3, 2025
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

IT (1)