NCT06320223

Brief Summary

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:

  • 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
108mo left

Started Mar 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Mar 2024Mar 2035

Study Start

First participant enrolled

March 5, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 6, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2034

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2035

Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

10 years

First QC Date

March 6, 2024

Last Update Submit

March 15, 2024

Conditions

Prostate CancerPET/CTSurvivorshipPSMA

Keywords

Prostate CancerPET/CTSurvivorshipPSMANuclear MedicineImagingOncologyUrology

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Time from PSMA-PET until death

    up to 10 years

Secondary Outcomes (1)

  • Metastasis-free survival

    up to 10 years

Study Arms (1)

Prostate cancer patients with PSMA PET

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.

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with biopsy/histo proven prostate cancer who underwent PSMA PET for staging at various stages will be included consecutively. All stages will be included: Primary, BCR, nmCRPC, mHSPC, mCRPC and advanced mCRPC.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with neuroendocrine prostate cancer
  • Patients with metastasized or disseminated malignancy other than prostate cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Essen

Essen, 45147, Germany

RECRUITING

Related Publications (2)

  • Karpinski 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. 2025 Oct 29:S0302-2838(25)04773-6. doi: 10.1016/j.eururo.2025.10.013. Online ahead of print.

    PMID: 41168067DERIVED

  • Karpinski 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: 39089299DERIVED

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Wolfgang P Fendler, M.D.

    University Hospital, Essen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wolfgang P Fendler, M.D.

CONTACT

+492017232032redcap@ikim.nrw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2024

First Posted

March 20, 2024

Study Start

March 5, 2024

Primary Completion (Estimated)

March 5, 2034

Study Completion (Estimated)

March 5, 2035

Last Updated

March 20, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)