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

March 15, 2024 updated by: University Hospital, Essen

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

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

Study Overview

Status

Recruiting

Conditions

Detailed Description

Background:

Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE) criteria have been defined for standardized reporting of Prostate-Specific Membrane Antigen (PSMA) Positron-Emission-Tomography (PET) whole-body stage of prostate cancer [Seifert et al. European Urology 2023]. PSMA PET disease extent by PROMISE has been associated with relevant oncologic outcome, specifically overall survival in patients with various stages of prostate cancer.

Need:

Improved risk assessment across various stages of prostate cancer is urgently needed for guidance of clinical management and prospective study design.

Aim:

  1. To assess the prognostic value of PSMA PET, summarized by PROMISE [Seifert et al EurUrol23]
  2. To compare the prognostic value of PSMA PET with established clinical prognostic scores in patients with prostate cancer at various disease stages
  3. To assess the association of PSMA PET stage with management, laboratory findings, histopathology findings or patient characteristics

Eligibility:

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 (Initial Staging), BCR (Biochemical Recurrence), nmCRPC (conventional non-metastatic castration-resistant prostate cancer), mHSPC (conventional metastatic hormone-sensitive prostate cancer), mCRPC (conventional metastatic castration-resistant prostate cancer) and advanced mCRPC.

Inclusion:

  • Adult patients with
  • histopathology 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

Statistical considerations:

This is an open registry study. The more data sets are contributed, the more precisely the diagnostic accuracy and prognostic value of PSMA PET can be determined for the overall cohort and subgroups.

Prognostic value of variables from PSMA-PET (PROMISE parameters, PSMA-Volume, Standardized Uptake Value (SUV) among other) and patient characteristics will be assessed by regression analysis and correlation analysis. Hazard ratio (95% Confidence Interval) and Concordance Index for the prediction of primary and secondary endpoints will be calculated. Primary endpoint is the association with overall survival. Secondary endpoints are the association with progression-free survival, management and other characteristics.

Central Database:

Data will be stored centrally in a RedCap Database with 3-step authentication at the sponsor site.

Recurring Data Entry:

Data entry will be conducted repeatedly at about 3 to 6 month intervals.

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Wolfgang P Fendler, M.D.
  • Phone Number: +492017232032
  • Email: redcap@ikim.nrw

Study Locations

  • Germany
      • Essen, Germany, 45147
        • Recruiting
        • University Hospital Essen
        • Contact:
          • Wolfgang P Fendler, M.D.
          • Phone Number: +492017232032
          • Email: redcap@ikim.nrw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: up to 10 years
Time from PSMA-PET until death
up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metastasis-free survival
Time Frame: up to 10 years
Time from PSMA-PET until development of new metastasis on any imaging
up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Essen

Investigators

  • Principal Investigator: Wolfgang P Fendler, M.D., University Hospital, Essen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2024

Primary Completion (Estimated)

March 5, 2034

Study Completion (Estimated)

March 5, 2035

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

March 15, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROMISE PET Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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