Clinical trial · Observational
PROMISE PET Registry on PSMA-PET and Outcome in Prostate Cancer
PROMISE Registry on Standardized Evaluation of PSMA-PET and Outcome in Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: PROMISE criteria have been defined for standardized reporting of Prostate-Specific Membrane Antigen (PSMA) PET whole-body stage of prostate cancer. PSMA PET disease extent by PROMISE has been associated with oncologic outcome. Need: Improved prognostication across various stages of prostate cancer is needed for management guidance and study design. Aim: 1. To assess the prognostic value of PSMA PET 2. To compare the prognostic value of PSMA PET with clinical prognostic scores in patients with prostate cancer at various disease stages Inclusion: * Adult patients with * biopsy/histo proven prostate cancer who * underwent PSMA PET (any type) * for staging or re-staging at any stage and who * have at least 3-year overall survival follow-up data available will be included consecutively. Exclusion: * Patients with neuroendocrine prostate cancer * Patients with metastasized or disseminated malignancy other than prostate cancer
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PET/CT | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| PSMA | — | UNRESOLVED | — |
| Survivorship | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Prostate cancer patients with PSMA PET
- description
- Inclusion: * Adult patients with * biopsy/histo proven prostate cancer who * underwent PSMA PET (any type) * for staging or re-staging at any stage and who * have at least 3-year overall survival follow-up data available will be included consecutively. Exclusion: * Patients with neuroendocrine prostate cancer * Patients with metastasized or disseminated malignancy other than prostate cancer.
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- up to 10 years
- description
- Time from PSMA-PET until death
Secondary outcomes (1)
- measure
- Metastasis-free survival
- timeFrame
- up to 10 years
- description
- Time from PSMA-PET until development of new metastasis on any imaging
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion: * Adult patients with * biopsy/histo proven prostate cancer who * underwent PSMA PET (any type) * for staging or re-staging at any stage and who * have at least 3-year overall survival follow-up data available will be included consecutively. Exclusion: * Patients with neuroendocrine prostate cancer * Patients with metastasized or disseminated malignancy other than prostate cancer.
References
Publications (2)
- DERIVEDKarpinski MJ, Hoberuck S, Fendler WP, Civan C, Bundschuh RA, Thomas C, Bjartell A, Tragardh E, Soeterik TFW, Evangelista L, Vondrak A, Rasul S, Forner L, Giorgio AD, Scholtissek H, Miksch J, Holzgreve A, Lanfranchi F, Rahbar K, Hofman MS, Rauscher I, Guven O, Eiber M, Ayati N, Umutlu L, Herrmann K, Hadaschik B, Emmett L. 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. Eur Urol. 2026 Feb;89(2):123-127. doi: 10.1016/j.eururo.2025.10.013. Epub 2025 Oct 29. PMID 41168067
- DERIVEDKarpinski MJ, Husing J, Claassen K, Moller L, Kajuter H, Oesterling F, Grunwald V, Umutlu L, Kleesiek J, Telli T, Merkel-Jens A, Husing A, Kesch C, Herrmann K, Eiber M, Hoberuck S, Meyer PT, Kind F, Rahbar K, Schafers M, Stang A, Hadaschik BA, Fendler WP. Combining PSMA-PET and PROMISE to re-define disease stage and risk in patients with prostate cancer: a multicentre retrospective study. Lancet Oncol. 2024 Sep;25(9):1188-1201. doi: 10.1016/S1470-2045(24)00326-7. Epub 2024 Jul 29. PMID 39089299