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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• number of PSMA-avid lesions (count) [Срок оценки: From baseline PET/CT through study completion, an average of 2 years]
• metabolic tumor volume (MTV in cm 3) [Срок оценки: From baseline PET/CT through study completion, an average of 2 years]
• maximum standardized uptake value (SUVmax, dimensionless) [Срок оценки: From baseline PET/CT through study completion, an average of 2 years]
• mean standardized uptake value (SUVmean, dimensionless) [Срок оценки: From baseline PET/CT through study completion, an average of 2 years]

Вторичные конечные точки (3)

• Prediction of Treatment Response via PSMA PET [Срок оценки: From baseline PET/CT through study completion, an average of 2 years]
• Comparative Analysis of Imaging Modalities [Срок оценки: From baseline PET/CT through study completion, an average of 2 years]
• Assessment of Tumor Volume Dynamics [Срок оценки: From baseline PET/CT through study completion, an average of 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 4 центра

• Nuclear Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
• Azienda Ospedaliera Santa Croce e Carle - ospedale Santa Croce — Cuneo
• U.O. Medicina Nucleare, IRCCS Ospedale Policlinico San Martino — Genova
• UOC Medicina Nucleare, AOU Policlinico G.Martino — Messina

Идентификаторы

NCT: NCT07089550 · 737/2024/Oss/AOUBO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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