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

Plain Language Summary

Simplified for easier understanding

This study (PELICAN) uses PSMA PET scans — a highly sensitive imaging tool that lights up prostate cancer cells — to track how well systemic (whole-body) drug treatments are working in men with advanced prostate cancer. The goal is to find better ways to measure treatment response. **You may be eligible if...** - You have a confirmed diagnosis of advanced prostate cancer (not neuroendocrine type) - You are about to start one of several systemic therapies (such as abiraterone, enzalutamide, docetaxel, lutetium PSMA, or others) - You are willing to have PSMA PET scans before and during treatment **You may NOT be eligible if...** - You have neuroendocrine prostate cancer - You have already started the systemic therapy being evaluated - You are unable to undergo PET imaging Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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).