Clinical Trial · NCT07089550

PSMA PET for Treatment Response evaLuation of systemIC Therapies in prostAte caNcer (PELICAN)

Overview

This prospective clinical study aims to evaluate the predictive power of PSMA PET imaging in patients with advanced prostate cancer who are receiving systemic drug therapies. The primary goal is to identify prognostic factors derived from PSMA PET imaging. These factors include the number of cancer lesions, the size of the tumor, and measurements known as SUVmax and SUVmean. By identifying these factors, the investigators aim to better group patients and predict those who may have a less favorable outcome. While PSMA PET imaging is highly accurate in locating cancer sites within the body, its ability to predict treatment response has not yet been thoroughly studied in a prospective manner for this patient population. This study will assess the predictive role of PSMA PET imaging and its ability to forecast treatment response across a range of systemic therapies, including hormone therapy and chemotherapy, in patients with both hormone-sensitive (HSPC) and castration-resistant (CRPC) prostate cancer.

Sponsor

Azienda Ospedaliero-Universitaria di Modena

Contacts

Andrea Di Giorgio, MD (CONTACT)

andrea.digiorgio@live.it

+390512143959

Andrea Farolfi (PRINCIPAL_INVESTIGATOR)

Andrea Farolfi, MD (CONTACT)

andrea.farolfi@aosp.bo.it

+390512143959

ClinicalTrials.gov

NCT07089550

Drug / Compound

PSMA-617

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: DOTA

PSMA-617

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: DOTA

Eligibility

Inclusion

Candidates to receive one or more of the following systemic therapies, in combination or alone: abiraterone, enzalutamide, apalutamide, darolutamide, docetaxel, cabazitaxel, olaparib, radiotherapy, lutetium-177-PSMA, actinium-225-PSMA;
Patients undergoing PSMA PET for pre-treatment disease staging;
Histological diagnosis of advanced prostate cancer (excluding neuroendocrine carcinoma);

Exclusion

Prostate cancer with a known significant neuroendocrine component;
Inability to remain supine and still for the PET/CT image acquisition;