A Single-center Prospective Interventional Study on FPG500 in Non-metastatic Prostate Cancer Patients
Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Mar 10, 2025
Trial Information
Current as of August 20, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new way to understand and treat non-metastatic prostate cancer, which means the cancer has not spread to other parts of the body. Researchers at a leading Italian hospital are using advanced testing to look for specific changes in genes that could help predict how the cancer might grow or spread. This information could help doctors decide on the best treatment options for patients, especially those at high risk of their cancer becoming more aggressive. The goal is to identify those who might need more immediate treatment and to monitor patients who are being watched closely without treatment.
To be eligible for this study, participants must have a confirmed diagnosis of either low-risk or high-risk prostate cancer. This includes patients who are either being actively monitored or are scheduled for surgery. However, individuals with other cancers or those already receiving certain treatments for prostate cancer will not be included. Those who join the trial can expect to undergo genetic testing, which could lead to a better understanding of their cancer and more personalized treatment plans. Overall, the hope is to improve outcomes for patients by using this advanced genomic information.
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- • histologically proven diagnosis of low-risk, or high-risk or locally advanced prostate cancer
- • high-risk and locally advanced prostate cancer undergoing surgery
- • low-risk prostate cancer undergoing active surveillance or surgery
- Exclusion Criteria:
- • previous or concomitant malignancies
- • patients already undergoing androgen suppression or other medical treatments for prostate cancer
About Fondazione Policlinico Universitario Agostino Gemelli Irccs
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Roma, , Italy
Patients applied
Trial Officials
maria chiara
Principal Investigator
Fondazione
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported