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

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.

Conditions

• Prostate Cancer Metastatic
• Prostate Cancer Metastatic to Bone
• Prostate Cancer
• Prostate Neoplasm
• Oligometastatic Disease
• Oligometastasis

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

Sponsors & Collaborators

• IRCCS Ospedale San Raffaele

  collaborator OTHER

• University Hospital of Cologne

  collaborator OTHER

• St. Antonius Hospital

  collaborator OTHER

• Istituto Europeo di Oncologia

  collaborator OTHER

• University Hospital, Udine, Italy

  collaborator OTHER

• Azienda Ospedaliera San Giovanni Battista

  collaborator OTHER

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

  collaborator OTHER

• Lund University

  collaborator OTHER

• Medical University of Warsaw

  collaborator OTHER

• Ziekenhuis Netwerk Antwerpen (ZNA)

  collaborator OTHER

• Medical University of Vienna

  lead OTHER

Principal Investigators

• Shahrokh F Shariat, MD PhD DDsc · Medical University of Vienna

• Pawel G Rajwa, MD PhD · Medical University of Vienna

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-31

Primary Completion

2031-01-01

Completion

2031-12-31