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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Essen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 5, 2034

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 5, 2035

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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