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

Recruiting

• Conditions: PSMA Positive Tumors or Tumor Tissues; Prostate Cancer Metastatic

• Registration Number: NCT07089550
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

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 Timeline

• Status Verified: 2025-03
• Study Start: 2025-04-02
• Study First Submitted: 2025-05-28
• Study First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-24
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-28
• Primary Completion: 2034-04-26
• Study Completion: 2034-04-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 1300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of PSMA-avid lesions (count)	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)	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)	From baseline PET/CT through study completion, an average of 2 years	maximum standardized uptake value (SUVmax, dimensionless)
mean standardized uptake value (SUVmean, dimensionless)	From baseline PET/CT through study completion, an average of 2 years	mean standardized uptake value (SUVmean, dimensionless)

Secondary Outcome Measures

Name	Time	Method
Prediction of Treatment Response via PSMA PET	From baseline PET/CT through study completion, an average of 2 years	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.
Comparative Analysis of Imaging Modalities	From baseline PET/CT through study completion, an average of 2 years	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.
Assessment of Tumor Volume Dynamics	From baseline PET/CT through study completion, an average of 2 years	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.

Trial Locations

Locations (4)

Nuclear Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy

Azienda Ospedaliera Santa Croce e Carle - ospedale Santa Croce; 🇮🇹 Cuneo, Italy

U.O. Medicina Nucleare, IRCCS Ospedale Policlinico San Martino; 🇮🇹 Genova, Italy

UOC Medicina Nucleare, AOU Policlinico G.Martino; 🇮🇹 Messina, Italy