NCT07089550 PSMA PET for Treatment Response evaLuation of systemIC Therapies in prostAte caNcer (PELICAN)
| NCT ID | NCT07089550 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | PSMA Positive Tumors or Tumor Tissues |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,300 participants |
| Start Date | 2025-04-02 |
| Primary Completion | 2034-04-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,300 participants in total. It began in 2025-04-02 with a primary completion date of 2034-04-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Andrea Farolfi
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Frequently Asked Questions
Who can join the NCT07089550 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying PSMA Positive Tumors or Tumor Tissues. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07089550 currently recruiting?
Yes, NCT07089550 is actively recruiting participants. Contact the research team at andrea.farolfi@aosp.bo.it for enrollment information.
Where is the NCT07089550 trial being conducted?
This trial is being conducted at Bologna, Italy, Cuneo, Italy, Genova, Italy, Messina, Italy.
Who is sponsoring the NCT07089550 clinical trial?
NCT07089550 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Andrea Farolfi at IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 1,300 participants.