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

Sponsor
Medical University of Vienna
Study ID
NCT06430411
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
MALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Radical prostatectomy — PROCEDURE
    Removal of the prostate and seminal vesicles.
  • Prostate irradiation — RADIATION
    Radiation therapy of the prostate.
  • Surgical metastasectomy — PROCEDURE
    Surgical removal of metastases.
  • Irradiation of metastases — RADIATION
    Radiation therapy of metastases.
  • Abiraterone acetate — DRUG
    Administered as part of multimodal treatment for oligometastatic prostate cancer
  • Enzalutamide — DRUG
    Administered as part of multimodal treatment for oligometastatic prostate cancer
  • Darolutamide — DRUG
    Administered as part of multimodal treatment for oligometastatic prostate cancer
  • Apalutamide — DRUG
    Administered as part of multimodal treatment for oligometastatic prostate cancer
  • Docetaxel — DRUG
    Administered as part of multimodal treatment for oligometastatic prostate cancer
  • Lutetium-PSMA — DRUG
    Administered as part of multimodal treatment for oligometastatic prostate cancer
  • Androgen deprivation treatment — DRUG
    Administered as part of multimodal treatment for oligometastatic prostate cancer

Study Details

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 Dates

Start date
May 31, 2024
Status verified
May 2024
Primary completion
Jan 1, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
500 participants (estimated)

Primary Outcome Measure

Radiographic progression-free survival (rPFS) [ Time Frame: 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 ]

Central Contacts

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