Actively Recruiting

Age: 18Years +
MALE
ID06320223

PROMISE Registry on Standardized Evaluation of PSMA-PET and Outcome in Prostate Cancer

Led by University Hospital, Essen · Updated on 2024-03-20

10000

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying prostate cancer patients who have undergone PSMA PET imaging, using PROMISE criteria to standardize disease staging. The study aims to assess how well PSMA PET predicts survival outcomes and compares its prognostic value with other clinical scores across different stages of prostate cancer. This research addresses the need for better risk prediction to guide treatment and study design. This observational study includes adult men with biopsy-confirmed prostate cancer who had PSMA PET scans for initial staging or restaging at any disease stage. Data on these patients will be collected repeatedly every 3 to 6 months and entered into a central database. The study includes patients with at least 3 years of survival follow-up and excludes those with neuroendocrine prostate cancer or other metastatic cancers. Participants will provide data over up to 10 years, including survival and disease progression information. Researchers will analyze these data to evaluate associations between PSMA PET findings and overall survival as the primary outcome, with metastasis-free survival as a secondary outcome. The study monitors how PSMA PET results relate to clinical management and patient characteristics, helping improve prognostic tools for prostate cancer.

CONDITIONS

Brief Title

PROMISE PET Registry on PSMA-PET and Outcome in Prostate Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult male patients aged 18 years or older
  • Biopsy or histology confirmed prostate cancer
  • Underwent any type of PSMA PET scan for staging or restaging
  • Have at least 3 years of overall survival follow-up data available
  • Patients included consecutively at any stage of prostate cancer
Not Eligible

You will not qualify if you...

  • Patients diagnosed with neuroendocrine prostate cancer
  • Patients with metastatic or disseminated malignancy other than prostate cancer

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 day

Participants undergo PSMA PET scans for staging or restaging of prostate cancer.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 10 years

Participants are followed for up to 10 years to assess overall survival, progression-free survival, and other outcomes.

Visits every 3 to 6 months for data collection

Trial Site Locations

Total: 1 location

1

University Hospital Essen

Essen, Germany, 45147

Actively Recruiting

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Research Team

W

Wolfgang P Fendler, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Association Between the PRIMARY Score at Staging Prostate-specific Membrane Antigen Positron Emission Tomography and Overall Survival Among Patients with Newly Diagnosed Prostate Cancer: Findings from the International, Multicenter PROMISE Registry.

Madeleine J Karpinski, Sebastian Hoberück, Wolfgang P Fendler...

https://pubmed.ncbi.nlm.nih.gov/41168067

Combining PSMA-PET and PROMISE to re-define disease stage and risk in patients with prostate cancer: a multicentre retrospective study.

Madeleine J Karpinski, Johannes Hüsing, Kevin Claassen...

https://pubmed.ncbi.nlm.nih.gov/39089299