RecruitingNot Applicable

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

Italy1,300 participantsStarted 2025-04-02

Plain-language 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.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

number of PSMA-avid lesions (count)

Timeframe: From baseline PET/CT through study completion, an average of 2 years

metabolic tumor volume (MTV in cm 3)

Timeframe: From baseline PET/CT through study completion, an average of 2 years

maximum standardized uptake value (SUVmax, dimensionless)

Timeframe: From baseline PET/CT through study completion, an average of 2 years

mean standardized uptake value (SUVmean, dimensionless)

Timeframe: From baseline PET/CT through study completion, an average of 2 years

Trial details

NCT IDNCT07089550

SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2034-04-26

Contact for this trial

Andrea Farolfi, MD

+390512143959 andrea.farolfi@aosp.bo.it

View on ClinicalTrials.gov More PSMA Positive Tumors or Tumor Tissues trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

number of PSMA-avid lesions (count)

Timeframe: From baseline PET/CT through study completion, an average of 2 years

metabolic tumor volume (MTV in cm 3)

Timeframe: From baseline PET/CT through study completion, an average of 2 years

maximum standardized uptake value (SUVmax, dimensionless)

Timeframe: From baseline PET/CT through study completion, an average of 2 years

mean standardized uptake value (SUVmean, dimensionless)

Timeframe: From baseline PET/CT through study completion, an average of 2 years