Clinical trial NCT06320223: PROMISE PET Registry on PSMA-PET and Outcome in Prostate Cancer
Official title: PROMISE Registry on Standardized Evaluation of PSMA-PET and Outcome in Prostate Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
PET/CT
Survivorship
PSMA
Keywords: Prostate Cancer
PET/CT
Survivorship
PSMA
Nuclear Medicine
Imaging
Oncology
Urology
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 10000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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
* 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

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.

Eligibility criteria: 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:
measure: Overall survival
timeFrame: up to 10 years
Secondary outcomes:
measure: Metastasis-free survival
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital Essen
Study officials:
affiliation: University Hospital, Essen
name: Wolfgang P Fendler, M.D.
role: PRINCIPAL_INVESTIGATOR
References: