PSMA PET for Treatment Response evaLuation of systemIC Therapies in prostAte caNcer (PELICAN)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 population
This study will enroll male patients aged 18 years or older with a histologically confirmed diagnosis of advanced prostate cancer (excluding neuroendocrine carcinoma).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
PSMA PET/CT scan
RadiationAll Patients undergoing PSMA PET for pre-treatment disease staging with different radiotracers (\[68Ga\]Ga-PSMA-11, \[18F\]-DCFPyL, \[18F\]-PSMA-1007).
Treatment groups
1,300 Participants
are divided into 1 treatment groupGroup A: PELICAN population1 intervention
Trial outcomes
Primary outcomes
1
number of PSMA-avid lesions (count)
number of PSMA-avid lesions (count)
Time frame
From baseline PET/CT through study completion, an average of 2 years2
metabolic tumor volume (MTV in cm 3)
metabolic tumor volume (MTV in cm 3)
Time frame
From baseline PET/CT through study completion, an average of 2 years3
maximum standardized uptake value (SUVmax, dimensionless)
maximum standardized uptake value (SUVmax, dimensionless)
Time frame
From baseline PET/CT through study completion, an average of 2 years4
mean standardized uptake value (SUVmean, dimensionless)
mean standardized uptake value (SUVmean, dimensionless)
Time frame
From baseline PET/CT through study completion, an average of 2 yearsSecondary outcomes
1
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.
Time frame
From baseline PET/CT through study completion, an average of 2 years2
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.
Time frame
From baseline PET/CT through study completion, an average of 2 years3
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.
Time frame
From baseline PET/CT through study completion, an average of 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead sponsor
Ospedale Policlinico San Martino
Collaborator
Ospedale Santa Croce-Carle Cuneo
Collaborator
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Collaborator
Source ClinicalTrials.gov