Prostate CancerPROMISE-PETNCT06320223
PROMISE PET Registry on PSMA-PET and Outcome in Prostate Cancer
An observational study of Prostate Cancer and PET/CT, run by University Hospital, Essen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, PET/CT, Survivorship
- How many people
- 10,000 participants
- Where
- 1 siteGermany
- Study dates
- 5 Mar 2024to 5 Mar 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients with neuroendocrine prostate cancer
- Patients with metastasized or disseminated malignancy other than prostate cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Essen
Essen, 45147
Wolfgang P Fendler, M.D., +492017232032, redcap@ikim.nrw
About this study
Official title: 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.
Read more
Need:
Improved prognostication across various stages of prostate cancer is needed for management guidance and study design.
Aim:
- To assess the prognostic value of PSMA PET
- 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
Read the 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:
- To assess the prognostic value of PSMA PET, summarized by PROMISE [Seifert et al EurUrol23]
- To compare the prognostic value of PSMA PET with established clinical prognostic scores in patients with prostate cancer at various disease stages
- 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.
- Conditions
- Prostate Cancer, PET/CT, Survivorship, PSMA
- Keywords
- Prostate Cancer, PET/CT, Survivorship, PSMA, Nuclear Medicine, Imaging, Oncology, Urology
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Time from PSMA-PET until death
Measured: up to 10 years
Secondary outcomes (1)
Metastasis-free survival
Time from PSMA-PET until development of new metastasis on any imaging
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start5 Mar 2024
- Primary completion5 Mar 2034 (estimated)
- Study completion5 Mar 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wolfgang P Fendler, M.D., Principal investigator, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320223
- Sponsor's protocol ID
- PROMISE PET Registry
- Acronym
- PROMISE-PET
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karpinski MJ, Hoberuck S, Fendler WP, Civan C, Bundschuh RA, Thomas C, Bjartell A, Tragardh E, Soeterik TFW, Evangelista L, Vondrak A, Rasul S, Forner L, Giorgio AD, Scholtissek H, Miksch J, Holzgreve A, Lanfranchi F, Rahbar K, Hofman MS, Rauscher I, Guven O, Eiber M, Ayati N, Umutlu L, Herrmann K, Hadaschik B, Emmett L. Association Between the PRIMARY Score at Staging Prostate-specific Membrane Antigen Positron Emission Tomography and Overall Survival Among Patients with Newly Diagnosed Prostate Cancer: Findings from the International, Multicenter PROMISE Registry. Eur Urol. 2026 Feb;89(2):123-127. doi: 10.1016/j.eururo.2025.10.013. Epub 2025 Oct 29.
PubMed 41168067Karpinski MJ, Husing J, Claassen K, Moller L, Kajuter H, Oesterling F, Grunwald V, Umutlu L, Kleesiek J, Telli T, Merkel-Jens A, Husing A, Kesch C, Herrmann K, Eiber M, Hoberuck S, Meyer PT, Kind F, Rahbar K, Schafers M, Stang A, Hadaschik BA, Fendler WP. Combining PSMA-PET and PROMISE to re-define disease stage and risk in patients with prostate cancer: a multicentre retrospective study. Lancet Oncol. 2024 Sep;25(9):1188-1201. doi: 10.1016/S1470-2045(24)00326-7. Epub 2024 Jul 29.
PubMed 39089299
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROMISE Registry on Standardized Evaluation of PSMA-PET and Outcome in Prostate Cancer
- ClinicalTrials.gov ID
- NCT06320223
- Acronym / sponsor ID
- PROMISE-PET / PROMISE PET Registry
- Conditions
- Prostate Cancer, PET/CT, Survivorship, PSMA
- Keywords
- Prostate Cancer, PET/CT, Survivorship, PSMA, Nuclear Medicine, Imaging, Oncology, Urology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 5 Mar 2034 (estimated)
- Study completion
- 5 Mar 2035 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess the prognostic value of PSMA PET
- 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:
- To assess the prognostic value of PSMA PET, summarized by PROMISE [Seifert et al EurUrol23]
- To compare the prognostic value of PSMA PET with established clinical prognostic scores in patients with prostate cancer at various disease stages
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with neuroendocrine prostate cancer
- Patients with metastasized or disseminated malignancy other than prostate cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: up to 10 years
Time from PSMA-PET until death
1 secondary outcome
Metastasis-free survival
Time frame: up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Derived from this study: PubMed 41168067Karpinski MJ, Hoberuck S, Fendler WP, Civan C, Bundschuh RA, Thomas C, Bjartell A, Tragardh E, Soeterik TFW, Evangelista L, Vondrak A, Rasul S, Forner L, Giorgio AD, Scholtissek H, Miksch J, Holzgreve A, Lanfranchi F, Rahbar K, Hofman MS, Rauscher I, Guven O, Eiber M, Ayati N, Umutlu L, Herrmann K, Hadaschik B, Emmett L. Association Between the PRIMARY Score at Staging Prostate-specific Membrane Antigen Positron Emission Tomography and Overall Survival Among Patients with Newly Diagnosed Prostate Cancer: Findings from the International, Multicenter PROMISE Registry. Eur Urol. 2026 Feb;89(2):123-127. doi: 10.1016/j.eururo.2025.10.013. Epub 2025 Oct 29.
- Derived from this study: PubMed 39089299Karpinski MJ, Husing J, Claassen K, Moller L, Kajuter H, Oesterling F, Grunwald V, Umutlu L, Kleesiek J, Telli T, Merkel-Jens A, Husing A, Kesch C, Herrmann K, Eiber M, Hoberuck S, Meyer PT, Kind F, Rahbar K, Schafers M, Stang A, Hadaschik BA, Fendler WP. Combining PSMA-PET and PROMISE to re-define disease stage and risk in patients with prostate cancer: a multicentre retrospective study. Lancet Oncol. 2024 Sep;25(9):1188-1201. doi: 10.1016/S1470-2045(24)00326-7. Epub 2024 Jul 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wolfgang P Fendler, M.D. principal investigator
University Hospital, Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and PET/CT, run by University Hospital, Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wolfgang P Fendler, M.D. (+492017232032, redcap@ikim.nrw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06320223, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.