TheranosticTrials.org

Clinical Trial · NCT06430411

Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: OLIGOMET Study

Overview

PSMA-PET/CT or PSMA-PET/MRI are more accurate imaging modalities compared to CT/BS; in approximately 10-20% of high-risk patients diagnosed using conventional imaging PSMA-PET up-stages the disease. Therefore a substantial proportion of high-risk patients previously considered as non-metastatic are expected to be diagnosed with oligometastatic disease. While standard treatment pathways exist for patients with non-metastatic or oligometastatic disease confirmed using conventional imaging, less is known about the optimal management of patients with oligometastatic prostate cancer on PSMA-PET. Currently, data on the safety, effectiveness and oncologic outcomes of local therapies in oligometastatic patients diagnosed using PSMA-PET have been poorly reported so far. Thus, there is a need for a prospectively maintained database to collect real-world clinical data to produce high-quality research on the optimal management in oligometastatic prostate cancer who underwent PSMA-PET for primary staging and subsequent local therapy. This database will allow centers to retro- and prospectively collect data to facilitate analysis and assessment of the outcomes of oligometastatic patients managed with local therapy.

Sponsor

Medical University of Vienna

Contacts

Pawel G Rajwa, MD PhD (PRINCIPAL_INVESTIGATOR)

Shahrokh F Shariat, MD PhD DDsc (PRINCIPAL_INVESTIGATOR)

Tamás Fazekas, MD (CONTACT)

fazekastamas192@gmail.com

+36-70-611-8524

Pawel G Rajwa, MD PhD (CONTACT)

pawelgrajwa@gmail.com

+48-604-090-416

ClinicalTrials.gov

NCT06430411

Drug / Compound

PSMA-617

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTA

PSMA

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

Eligibility

Inclusion

  • * Oligometastatic prostate cancer diagnosed using PSMA PET defined as cM1a and/or cM1b with ≤5 osseous metastases and/or M1c with ≤3 lung lesions, with or without cN positivity.
  • Any Gleason Score, any cT stage, any PSA
  • Oligometastatic prostate cancer treated with primary local therapy such as radical prostatectomy or radiation therapy.

Exclusion

  • Patients who did not undergo imaging before local treatment.
  • * Visceral metastases (apart from lungs).
  • Non-metastatic prostate cancer.
  • Neoadjuvant therapy prior to first PSMA PET.