PSMA Positive Tumors or Tumor TissuesPELICANNCT07089550
PSMA PET for Treatment Response evaLuation of systemIC Therapies in prostAte caNcer (PELICAN)
An observational study of PSMA Positive Tumors or Tumor Tissues and Prostate Cancer Metastatic, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 4 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- PSMA Positive Tumors or Tumor Tissues, Prostate Cancer Metastatic
- What is being tested?
- PSMA PET/CT scan
- Type of treatment
- Surgery or procedure
- How many people
- 1,300 participants
- Where
- 4 sitesItaly
- Study dates
- 2 Apr 2025to 26 Apr 2034
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll male patients aged 18 years or older with a histologically confirmed diagnosis of advanced prostate cancer (excluding neuroendocrine carcinoma).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites, 4 recruiting
- Recruiting
Nuclear Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138
Andrea Farolfi, MD, +390512143959, andrea.farolfi@aosp.bo.it
Andrea Farolfi, MD
- Recruiting
Azienda Ospedaliera Santa Croce e Carle - ospedale Santa Croce
Cuneo, Italy, 12100
Virgini Liberini, MD, +390171641111, v.liberini@gmail.com
Virgini Liberini, MD
- Recruiting
U.O. Medicina Nucleare, IRCCS Ospedale Policlinico San Martino
Genova, Italy, 16131
Matteo Bauckneht, MD, +39010555 4812
matteo.bauckneht@gmail.com
- Recruiting
UOC Medicina Nucleare, AOU Policlinico G.Martino
Messina, Italy, 98125
Riccardo Laudicella, MD, +390902212841, riccardo.laudicella@unime.it
Riccardo Laudicella, MD
About this study
Official title: PSMA PET for Treatment Response evaLuation of systemIC Therapies in prostAte caNcer (PELICAN), an Italian Multicenter Study
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.
Read the detailed description
Purpose: to determine the prognostic value of PSMA PET imaging in patients diagnosed with advanced prostate cancer who are undergoing systemic therapies. The study will enroll patients with either hormone-sensitive (HSPC) or castration-resistant (CRPC) disease.
Design of the register: observational, pharmacological, non-profit, prospective, multicentric.
Duration of the record: The expected duration for the collection of PET/CT-PSMA examinations is 9 years.
The primary objective is to evaluate the predictive capacity of PSMA PET, focusing on quantitative parameters such as the number of lesions, tumor volume (as assessed by metabolic tumor volume - MTV), maximum standardized uptake value (SUVmax), and mean standardized uptake value (SUVmean), to stratify patient risk and predict unfavorable clinical outcomes (e.g., progression-free survival, overall survival).
This research will address the existing knowledge gap regarding the predictive ability of PSMA PET beyond its established role in disease localization. Specifically, the study will investigate if PSMA PET parameters can forecast response to a spectrum of systemic treatments, including but not limited to: abiraterone, enzalutamide, apalutamide, darolutamide, docetaxel, cabazitaxel, olaparib, radiotherapy, 177-lutetium PSMA, and 225-actinium PSMA.
Secondary objectives include:
- Identifying PSMA PET-derived biomarkers that predict response to the aforementioned systemic therapies.
- Assessing the incremental prognostic and predictive value of PSMA PET in conjunction with standard imaging modalities, namely CT, MRI, and bone scan, in patients undergoing multiple imaging assessments.
- Evaluating the correlation between changes in PSMA PET-derived tumor volume during treatment and clinical outcomes.
This study will leverage quantitative imaging data obtained from PSMA PET to develop predictive models that may refine patient stratification and personalize treatment strategies for advanced prostate cancer.
- Being tested
- PSMA PET/CT scan
- Keywords
- PSMA PET/CT, mCRPC, mHSPC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA PET/CT scanRadiation
All Patients undergoing PSMA PET for pre-treatment disease staging with different radiotracers ([68Ga]Ga-PSMA-11, [18F]-DCFPyL, [18F]-PSMA-1007).
| Study group | Role | What they receive |
|---|---|---|
| PELICAN population | Patients with either hormone-sensitive (HSPC) or castration-resistant (CRPC) prostate cancer Receives: Radiation: PSMA PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of PSMA-avid lesions (count)
number of PSMA-avid lesions (count)
Measured: From baseline PET/CT through study completion, an average of 2 years
metabolic tumor volume (MTV in cm 3)
metabolic tumor volume (MTV in cm 3)
Measured: From baseline PET/CT through study completion, an average of 2 years
maximum standardized uptake value (SUVmax, dimensionless)
maximum standardized uptake value (SUVmax, dimensionless)
Measured: From baseline PET/CT through study completion, an average of 2 years
mean standardized uptake value (SUVmean, dimensionless)
mean standardized uptake value (SUVmean, dimensionless)
Measured: From baseline PET/CT through study completion, an average of 2 years
Secondary outcomes (3)
Prediction of Treatment Response via PSMA PET
Predictive value of PSMA PET-derived parameters in forecasting patient response to systemic therapies (abiraterone, enzalutamide, apalutamide, darolutamide, docetaxel, cabazitaxel, olaparib, radiotherapy, 177-lutetium PSMA, 225-actinium PSMA). This will be assessed by correlating PSMA PET metrics with established clinical and radiological response criteria for each respective therapy.
Measured: From baseline PET/CT through study completion, an average of 2 years
Comparative Analysis of Imaging Modalities
Incremental predictive and prognostic value of PSMA PET, when used in conjunction with standard imaging techniques (CT, MRI, bone scan). This will involve comparing the predictive accuracy of PSMA PET alone versus combined imaging approaches in predicting treatment outcomes and patient survival.
Measured: From baseline PET/CT through study completion, an average of 2 years
Assessment of Tumor Volume Dynamics
Correlation between changes in PSMA PET-derived tumor volume (MTV) during the course of systemic treatment and patient clinical outcomes, including but not limited to, progression-free survival and overall survival. This will assess the utility of dynamic MTV changes as a surrogate marker for treatment response.
Measured: From baseline PET/CT through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start2 Apr 2025
- Primary completion26 Apr 2034 (estimated)
- Study completion26 Apr 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PSMA Positive Tumors or Tumor TissuesStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,300 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale Policlinico San Martino, Ospedale Santa Croce-Carle Cuneo, Azienda Ospedaliera Universitaria Policlinico "G. Martino"
- Responsible party
- Principal investigator, Andrea Farolfi, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Andrea Farolfi, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089550
- Sponsor's protocol ID
- 737/2024/Oss/AOUBO
- Acronym
- PELICAN
- Status last verified
- Feb 2026
- First submitted
- 28 May 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PSMA PET for Treatment Response evaLuation of systemIC Therapies in prostAte caNcer (PELICAN), an Italian Multicenter Study
- ClinicalTrials.gov ID
- NCT07089550
- Acronym / sponsor ID
- PELICAN / 737/2024/Oss/AOUBO
- Keywords
- PSMA PET/CT, mCRPC, mHSPC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Collaborators
- Ospedale Policlinico San Martino, Ospedale Santa Croce-Carle Cuneo, Azienda Ospedaliera Universitaria Policlinico "G. Martino"
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 26 Apr 2034 (estimated)
- Study completion
- 26 Apr 2034 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose: to determine the prognostic value of PSMA PET imaging in patients diagnosed with advanced prostate cancer who are undergoing systemic therapies. The study will enroll patients with either hormone-sensitive (HSPC) or castration-resistant (CRPC) disease.
Design of the register: observational, pharmacological, non-profit, prospective, multicentric.
Duration of the record: The expected duration for the collection of PET/CT-PSMA examinations is 9 years.
The primary objective is to evaluate the predictive capacity of PSMA PET, focusing on quantitative parameters such as the number of lesions, tumor volume (as assessed by metabolic tumor volume - MTV), maximum standardized uptake value (SUVmax), and mean standardized uptake value (SUVmean), to stratify patient risk and predict unfavorable clinical outcomes (e.g., progression-free survival, overall survival).
This research will address the existing knowledge gap regarding the predictive ability of PSMA PET beyond its established role in disease localization. Specifically, the study will investigate if PSMA PET parameters can forecast response to a spectrum of systemic treatments, including but not limited to: abiraterone, enzalutamide, apalutamide, darolutamide, docetaxel, cabazitaxel, olaparib, radiotherapy, 177-lutetium PSMA, and 225-actinium PSMA.
Secondary objectives include:
- Identifying PSMA PET-derived biomarkers that predict response to the aforementioned systemic therapies.
- Assessing the incremental prognostic and predictive value of PSMA PET in conjunction with standard imaging modalities, namely CT, MRI, and bone scan, in patients undergoing multiple imaging assessments.
- Evaluating the correlation between changes in PSMA PET-derived tumor volume during treatment and clinical outcomes.
This study will leverage quantitative imaging data obtained from PSMA PET to develop predictive models that may refine patient stratification and personalize treatment strategies for advanced prostate cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PELICAN population | – | Radiation: PSMA PET/CT scanPatients with either hormone-sensitive (HSPC) or castration-resistant (CRPC) prostate cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll male patients aged 18 years or older with a histologically confirmed diagnosis of advanced prostate cancer (excluding neuroendocrine carcinoma).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSMA PET/CT scanAll Patients undergoing PSMA PET for pre-treatment disease staging with different radiotracers ([68Ga]Ga-PSMA-11, [18F]-DCFPyL, [18F]-PSMA-1007). | Radiation | PELICAN population |
Primary outcome
number of PSMA-avid lesions (count)
Time frame: From baseline PET/CT through study completion, an average of 2 years
number of PSMA-avid lesions (count)
metabolic tumor volume (MTV in cm 3)
Time frame: From baseline PET/CT through study completion, an average of 2 years
metabolic tumor volume (MTV in cm 3)
maximum standardized uptake value (SUVmax, dimensionless)
Time frame: From baseline PET/CT through study completion, an average of 2 years
maximum standardized uptake value (SUVmax, dimensionless)
mean standardized uptake value (SUVmean, dimensionless)
Time frame: From baseline PET/CT through study completion, an average of 2 years
mean standardized uptake value (SUVmean, dimensionless)
3 secondary outcomes
Prediction of Treatment Response via PSMA PET
Time frame: From baseline PET/CT through study completion, an average of 2 years
Comparative Analysis of Imaging Modalities
Time frame: From baseline PET/CT through study completion, an average of 2 years
Assessment of Tumor Volume Dynamics
Time frame: From baseline PET/CT through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Diagnostic Performance of PET/CT-PSMA in Patients With Non-prostatic PSMA-expressing Neoplasms
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Farolfi principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PSMA Positive Tumors or Tumor Tissues and Prostate Cancer Metastatic, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Farolfi, MD (+390512143959, andrea.farolfi@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of PSMA-avid lesions (count) (time frame: From baseline PET/CT through study completion, an average of 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.