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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Radiation
Study Type: Observational
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Nuclear Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna
RECRUITING
Bologna
Azienda Ospedaliera Santa Croce e Carle - ospedale Santa Croce
RECRUITING
Cuneo
U.O. Medicina Nucleare, IRCCS Ospedale Policlinico San Martino
NOT_YET_RECRUITING
Genova
UOC Medicina Nucleare, AOU Policlinico G.Martino
NOT_YET_RECRUITING
Messina
Contact Information
Primary
Andrea Farolfi, MD
andrea.farolfi@aosp.bo.it
+390512143959
Backup
Andrea Di Giorgio, MD
andrea.digiorgio@live.it
+390512143959
Time Frame
Start Date: 2025-04-02
Estimated Completion Date: 2034-04-26
Participants
Target number of participants: 1300
Treatments
PELICAN population
Patients with either hormone-sensitive (HSPC) or castration-resistant (CRPC) prostate cancer
Related Therapeutic Areas
Sponsors
Collaborators: Azienda Ospedaliera Universitaria Policlinico G. Martino, Ospedale Policlinico San Martino, Ospedale Santa Croce-Carle Cuneo
Leads: IRCCS Azienda Ospedaliero-Universitaria di Bologna

This content was sourced from clinicaltrials.gov