RecruitingNCT07089550

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

PSMA PET for Treatment Response evaLuation of systemIC Therapies in prostAte caNcer (PELICAN), an Italian Multicenter Study

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

1,300 participants

Start Date

Apr 2, 2025

Study Type

OBSERVATIONAL

Conditions

Prostate Cancer Metastatic PSMA Positive Tumors or Tumor Tissues

Summary

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

Sex: MALEMin Age: 18 Years

Inclusion Criteria4

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.

Exclusion Criteria3

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.

Interventions

RADIATIONPSMA PET/CT scan

All Patients undergoing PSMA PET for pre-treatment disease staging with different radiotracers (\[68Ga\]Ga-PSMA-11, \[18F\]-DCFPyL, \[18F\]-PSMA-1007).