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NCT07089550RECRUITING

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

PSMA PET for Treatment Response evaLuation of systemIC Therapies in prostAte caNcer (PELICAN), an Italian Multicenter Study

Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna + Ospedale Policlinico San Martino, Ospedale Santa Croce-Carle Cuneo

No open prediction endpoints

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Key Facts

Study type
OBSERVATIONAL
Conditions
PSMA Positive Tumors or Tumor Tissues, Prostate Cancer Metastatic
Interventions
PSMA PET/CT scan
Enrollment
1,300 participants
Primary completion
Apr 2034
Study completion
Apr 2034
First posted
Jul 2025
Last updated
Feb 2026

Primary Endpoints (CT.gov)

number of PSMA-avid lesions (count)

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

metabolic tumor volume (MTV in cm 3)

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

maximum standardized uptake value (SUVmax, dimensionless)

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

mean standardized uptake value (SUVmean, dimensionless)

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

Secondary Endpoints

Prediction of Treatment Response via PSMA PET

Comparative Analysis of Imaging Modalities

Assessment of Tumor Volume Dynamics

Eligibility Criteria

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.

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov