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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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.

Eligibility criteria

Qualifiers

Histological diagnosis of advanced prostate cancer (excluding neuroendocrine carcinoma);

Patients undergoing PSMA PET for pre-treatment disease staging;

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;

Provision of signed informed consent for study participation and data handling.

Disqualifiers

Inability to remain supine and still for the PET/CT image acquisition;

Prostate cancer with a known significant neuroendocrine component;

Presence of another concurrent malignancy, with the exception of non-melanoma skin cancer.

Trial design

Treatments tested in this trial

  • PSMA PET/CT scan

Treatment groups

1,300 Participants
are divided into 1 treatment group

Sponsors and collaborators

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Lead sponsor

Ospedale Policlinico San Martino

Collaborator

Ospedale Santa Croce-Carle Cuneo

Collaborator

Azienda Ospedaliera Universitaria Policlinico "G. Martino"

Collaborator