Clinical trial · Observational
Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: OLIGOMET Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oligometastasis | — | UNRESOLVED | — |
| Oligometastatic Disease | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer Metastatic | — | UNRESOLVED | — |
| Prostate Cancer Metastatic to Bone | — | UNRESOLVED | — |
| Prostate Neoplasm | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abiraterone acetate | Drug | Abiraterone Acetate | ALIAS |
| Androgen deprivation treatment | Drug | — | UNRESOLVED |
| Apalutamide | Drug | Apalutamide | ALIAS |
| Darolutamide | Drug | Darolutamide | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Enzalutamide | Drug | Enzalutamide | ALIAS |
| Irradiation of metastases | Radiation | — | UNRESOLVED |
| Lutetium-PSMA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Radiographic progression-free survival (rPFS)
- timeFrame
- From date of diagnosis until the date of first documented radiographic progression or date of death from any cause, whichever came first, assessed up to 100 months
- description
- Defined as increase in size of existing lesion or appearance of new lesion (on any subsequent follow-up imaging modality used for baseline assessment), or death.
- measure
- Clinical progression-free survival (cPFS)
- timeFrame
- From date of diagnosis until the date of first documented clinical progression or date of death from any cause, whichever came first, assessed up to 100 months
- description
- Defined as new prostate cancer-related symptom, radiographic progression, initiation of new treatment, or death.
- measure
- Castration resistance-free survival (CRPC-FS)
- timeFrame
- From date of diagnosis until the date of castration resistance or date of death from any cause, whichever came first, assessed up to 100 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available