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

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

Study 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.

Eligibility

Primary outcome measure(s)

• 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)

Trial sites (4)

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