Actively Recruiting

Age: 18Years +
MALE
NCT07089550

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

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2026-02-20

1300

Participants Needed

4

Research Sites

473 weeks

Total Duration

On this page

Sponsors

I

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Lead Sponsor

O

Ospedale Policlinico San Martino

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histological diagnosis of advanced prostate cancer (excluding neuroendocrine carcinoma)
  • Patients undergoing PSMA PET for pre-treatment disease staging
  • Candidates to receive one or more systemic therapies, including abiraterone, enzalutamide, apalutamide, darolutamide, docetaxel, cabazitaxel, olaparib, radiotherapy, lutetium-177-PSMA, or actinium-225-PSMA
  • Signed informed consent for study participation and data handling
Not Eligible

You will not qualify if you...

  • Unable to remain supine and still for PET/CT image acquisition
  • Prostate cancer with a significant neuroendocrine component
  • Presence of another concurrent malignancy except non-melanoma skin cancer

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Nuclear Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy, Italy, 40138

Actively Recruiting

2

Azienda Ospedaliera Santa Croce e Carle - ospedale Santa Croce

Cuneo, Italy, Italy, 12100

Actively Recruiting

3

U.O. Medicina Nucleare, IRCCS Ospedale Policlinico San Martino

Genova, Italy, Italy, 16131

Actively Recruiting

4

UOC Medicina Nucleare, AOU Policlinico G.Martino

Messina, Italy, Italy, 98125

Actively Recruiting

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Research Team

A

Andrea Farolfi, MD

CONTACT

A

Andrea Di Giorgio, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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