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NOT YET RECRUITING
NCT06430411

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

Sponsor: Medical University of Vienna

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

MALE

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2024-05-31

Completion Date

2031-12-31

Last Updated

2024-05-28

Healthy Volunteers

No

Interventions

PROCEDURE

Radical prostatectomy

Removal of the prostate and seminal vesicles.

RADIATION

Prostate irradiation

Radiation therapy of the prostate.

PROCEDURE

Surgical metastasectomy

Surgical removal of metastases.

RADIATION

Irradiation of metastases

Radiation therapy of metastases.

DRUG

Abiraterone acetate

Administered as part of multimodal treatment for oligometastatic prostate cancer

DRUG

Enzalutamide

Administered as part of multimodal treatment for oligometastatic prostate cancer

DRUG

Darolutamide

Administered as part of multimodal treatment for oligometastatic prostate cancer

DRUG

Apalutamide

Administered as part of multimodal treatment for oligometastatic prostate cancer

DRUG

Docetaxel

Administered as part of multimodal treatment for oligometastatic prostate cancer

DRUG

Lutetium-PSMA

Administered as part of multimodal treatment for oligometastatic prostate cancer

DRUG

Androgen deprivation treatment

Administered as part of multimodal treatment for oligometastatic prostate cancer