Back to Search Results- Not Yet Recruiting
- Observational
- Drug & Procedure
- Medical University of Vienna
- 18 - 80 Years
Study Purpose
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.
Intervention
Drug : Darolutamide
Procedure : Radical prostatectomy
Radiation : Prostate irradiation
Procedure : Surgical metastasectomy
Radiation : Irradiation of metastases
Drug : Abiraterone acetate
Drug : Enzalutamide
Drug : Apalutamide
Drug : Docetaxel
Drug : Lutetium-PSMA
Drug : Androgen deprivation treatment
Eligibility Requirements
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
Minimum age: 18
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.
Recruiting status
Not Yet Recruiting
Estimated enrollment
500
Study start date
May 31, 2024
Study end date
Dec 31, 2031
Last updated
Mar 23, 2025
Primary purpose
N/A
Design
Observational
Intervention
Drug & Procedure
Study phase
N/A
Allocation
N/A
Sponsor:
Medical University of Vienna
Collaborator:
IRCCS Ospedale San Raffaele
University Hospital of Cologne
St. Antonius Hospital
Istituto Europeo di Oncologia
University Hospital, Udine, Italy
Azienda Ospedaliera San Giovanni Battista
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
Lund University
Medical University of Warsaw
Ziekenhuis Netwerk Antwerpen (ZNA)
Investigator:
Shahrokh F Shariat, MD PhD DDsc
Pawel G Rajwa, MD PhD
N/A
Publications
N/A
Websites
N/A
NCT06430411
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