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

NCT07089550 | Recruiting

• 1 other identifier: 737/2024/Oss/AOUBO
• Study Type: observational
• Target: 1,300
• Locations: 1 country
• Sites: 4

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.

Conditions

PSMA Positive Tumors or Tumor Tissues; Prostate Cancer Metastatic

Keywords

PSMA PET/CT; mCRPC; mHSPC

Outcome Measures

Primary Outcomes (4)

• number of PSMA-avid lesions (count)

  number of PSMA-avid lesions (count)

  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)

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

• maximum standardized uptake value (SUVmax, dimensionless)

  maximum standardized uptake value (SUVmax, dimensionless)

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

• mean standardized uptake value (SUVmean, dimensionless)

  mean standardized uptake value (SUVmean, dimensionless)

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

Secondary Outcomes (3)

• Prediction of Treatment Response via PSMA PET

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

• Comparative Analysis of Imaging Modalities

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

• Assessment of Tumor Volume Dynamics

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

Study Arms (1)

PELICAN population

Patients with either hormone-sensitive (HSPC) or castration-resistant (CRPC) prostate cancer

Radiation: PSMA PET/CT scan

Interventions

PSMA PET/CT scan RADIATION

All Patients undergoing PSMA PET for pre-treatment disease staging with different radiotracers (\[68Ga\]Ga-PSMA-11, \[18F\]-DCFPyL, \[18F\]-PSMA-1007).

PELICAN population

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ospedale Policlinico San Martino: collaborator
• Ospedale Santa Croce-Carle Cuneo: collaborator
• Azienda Ospedaliera Universitaria Policlinico "G. Martino": collaborator
• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (4)

Nuclear Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy, 40138, Italy

RECRUITING

Azienda Ospedaliera Santa Croce e Carle - ospedale Santa Croce

Cuneo, Italy, 12100, Italy

RECRUITING

U.O. Medicina Nucleare, IRCCS Ospedale Policlinico San Martino

Genova, Italy, 16131, Italy

RECRUITING

UOC Medicina Nucleare, AOU Policlinico G.Martino

Messina, Italy, 98125, Italy

RECRUITING

Study Officials

• Andrea Farolfi

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Farolfi, MD

CONTACT

+390512143959; andrea.farolfi@aosp.bo.it

Andrea Di Giorgio, MD

CONTACT

+390512143959; andrea.digiorgio@live.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: July 28, 2025
• Study Start: April 2, 2025
• Primary Completion (Estimated): April 26, 2034
• Study Completion (Estimated): April 26, 2034
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

IT (4)