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
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