Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer Metastatic | — | UNRESOLVED | — |
| PSMA Positive Tumors or Tumor Tissues | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PSMA PET/CT scan | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- PELICAN population
- description
- Patients with either hormone-sensitive (HSPC) or castration-resistant (CRPC) prostate cancer
- interventionNames
- Radiation: PSMA PET/CT scan
Primary outcomes (4)
- measure
- number of PSMA-avid lesions (count)
- timeFrame
- From baseline PET/CT through study completion, an average of 2 years
- description
- number of PSMA-avid lesions (count)
- measure
- metabolic tumor volume (MTV in cm 3)
- timeFrame
- From baseline PET/CT through study completion, an average of 2 years
- description
- metabolic tumor volume (MTV in cm 3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available