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/Actively Recruiting
Led by University Hospital, Essen · Updated on 2024-03-20
10000
Participants Needed
1
Research Sites
52 weeks
Total Duration
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
PROMISE PET Registry on PSMA-PET and Outcome in Prostate Cancer
W
Wolfgang P Fendler, M.D.
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University Hospital, Essen
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants undergo PSMA PET scans for staging or restaging of prostate cancer.
1 visit (in-person)
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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Madeleine J Karpinski, Johannes Hüsing, Kevin Claassen...
https://pubmed.ncbi.nlm.nih.gov/39089299/Madeleine J Karpinski, Sebastian Hoberück, Wolfgang P Fendler...
https://pubmed.ncbi.nlm.nih.gov/41168067/University Hospital, Essen
Lead Sponsor