Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06320223
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-03-06
Brief Title:
PROMISE PET Registry on PSMA-PET and Outcome in Prostate Cancer
Sponsor:
University Hospital Essen
Organization:
University Hospital Essen
Study Overview
Official Title:
PROMISE Registry on Standardized Evaluation of PSMA-PET and Outcome in Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMISE-PET
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
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
biopsyhisto 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
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
biopsyhisto 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
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 biopsyhisto 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
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 biopsyhisto 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None