PROMISE PET Registry on PSMA-PET and Outcome in Prostate Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorUniversity Hospital, Essen
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients with
biopsy/histo proven prostate cancer who
underwent PSMA PET (any type)
for staging or re-staging at any stage and who
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
10,000 Participants
are grouped into 1 trial groupGroup A: Prostate cancer patients with PSMA PET
Trial outcomes
Primary outcomes
1
Overall survival
Time from PSMA-PET until death
Time frame
up to 10 yearsSecondary outcomes
1
Metastasis-free survival
Time from PSMA-PET until development of new metastasis on any imaging
Time frame
up to 10 yearsSponsors and contacts
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Source ClinicalTrials.gov