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NCT06430411Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 28 May 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
500 (estimated)
First submitted
2 Apr 2024
Start date
31 May 2024
Primary completion date
1 Jan 2031
Lead sponsor
Medical University of Vienna
NCT number
NCT06430411

What you commit to

  • Study type: Observational
  • Planned participants: 500
  • From 31 May 2024 to the primary completion date, 1 Jan 2031
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Neoadjuvant therapy prior to first PSMA PET.

Other illness

  • Non-metastatic prostate cancer.

Other

  • Visceral metastases (apart from lungs).
  • Patients who did not undergo imaging before local treatment.

Who the study is looking for

  • 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

Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.