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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-80
SponsorMedical University of Vienna

About this trial

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.

Eligibility criteria

Qualifiers

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.

Oligometastatic prostate cancer treated with primary local therapy such as radical prostatectomy or radiation therapy.

Any Gleason Score, any cT stage, any PSA

Disqualifiers

Visceral metastases (apart from lungs).

Neoadjuvant therapy prior to first PSMA PET.

Non-metastatic prostate cancer.

Patients who did not undergo imaging before local treatment.

Trial design

Treatments tested in this trial

  • Radical prostatectomy
  • Prostate irradiation
  • Surgical metastasectomy
  • Irradiation of metastases
  • Abiraterone acetate
  • Enzalutamide
  • Darolutamide
  • Apalutamide
  • Docetaxel
  • Lutetium-PSMA
  • Androgen deprivation treatment

Treatment groups

No treatment groups listed

Locations

This trial has no locations

Sponsors and collaborators

Medical University of Vienna

Lead sponsor

IRCCS Ospedale San Raffaele

Collaborator

University Hospital of Cologne

Collaborator

St. Antonius Hospital

Collaborator

Istituto Europeo di Oncologia

Collaborator

University Hospital, Udine, Italy

Collaborator

Azienda Ospedaliera San Giovanni Battista

Collaborator

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice

Collaborator

Lund University

Collaborator

Medical University of Warsaw

Collaborator

Ziekenhuis Netwerk Antwerpen (ZNA)

Collaborator