Indication for Prostate Biopsy Due to Suspected Prostate CancerPROPOSeNCT03565289
PRospective Prostate biOmarker Study
An observational study of Indication for Prostate Biopsy Due to Suspected Prostate Cancer, run by ProteoMediX AG at 11 sites in 3 countries.
Trial summary
Correlation of a glycoprotein panel with prostate biopsy outcome and PCa aggressiveness Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Indication for Prostate Biopsy Due to Suspected Prostate Cancer
- What is being tested?
- Blood sample collection
- How many people
- 455 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 14 Aug 2018to 31 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 to 80 years
- Men only
- Adult, Older adult
Study population: Patients with an indication for prostate biopsy at the participating sites.
Who may be able to join
- Male patient between 45 and 80 years old.
- tPSA between 2 and 10 ng/ml
- Prostate volume >=35 ml
- Non-suspicious DRE for prostate cancer
- Scheduled for prostate biopsy
- Patient must give written informed consent
Who cannot join
- Patient not undergoing biopsy of the prostate
- Prior prostate biopsy within the last 12 months
- Transurethral resection of the prostate (TURP) in the last 5 years
- Patients with known acute or chronic prostatitis/cystitis or other known prostate abnormalities
- Patient taking 5-alpha-reductase inhibitor
- Any other prior treatment of the prostate (cryoablation, hifu, ire, radiation therapy, alcohol instillation, etc.)
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
Germany8 sites
Helios Klinikum Bad Saarow
Bad Saarow, 15526
Malteser Krankenhaus Bonn/Rhein-Sieg
Bonn, 53123
Städtisches Klinikum Braunschweig gGmbH
Braunschweig, 38126
Universitätsklinikum Frankfurt
Frankfurt, 60590
Martini Klinik am UKE GmbH
Hamburg, 20246
Marien-Hospital Herne
Herne, 44625
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149
Daikonie Klinikum Stuttgart
Stuttgart, 70176
Austria2 sites
Medizinische Universität Innsbruck
Innsbruck, 6020
Ordensklinikum Linz
Linz, Upper Austria, 6020
About this study
Official title: PRospective Prostate biOmarker Study (PROPOSe)
- Correlation of a glycoprotein panel with prostate biopsy outcome and PCa aggressiveness
Read the detailed description
The main objective of this study is to correlate a glycoprotein panel with prostate biopsy outcome, i.e. distinguishing PCa from benign prostatic conditions as well as high-grade cancer. The quantities of the two protein analytes cathepsin D (CTSD) and thrombospondin 1 (THBS1) are measured in human serum samples. In combination with percent free PSA (%fPSA), the results are correlated with prostate biopsy outcome. The potential future benefit of using this glycoprotein panel is to validate positive tPSA tests in men with negative digital rectal examination (DRE) and enlarged prostates to reduce the need for undergoing a biopsy, thereby reducing unnecessary biopsies and potentially predicting high-grade disease.
- Being tested
- Blood sample collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionDiagnostic test
During a routine blood draw an additional tube of blood will be taken for the study.
| Study group | Role | What they receive |
|---|---|---|
| All patients | All Receives: Diagnostic Test: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of PCA
Correlation of the glycoprotein panel algorithm with histological diagnosis of PCa
Measured: 6 months
Aggressiveness of PCA
Correlation of the glycoprotein panel algorithm with diagnosis of significant (Gleason Score ≥7) PCa
Measured: 6 months
Diagnosis of PCA
Correlation of the glycoprotein panel algorithm with histological diagnosis of PCa
Measured: 12 months
Aggressiveness of PCA
Correlation of the glycoprotein panel algorithm with diagnosis of significant (Gleason Score ≥7) PCa
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start14 Aug 2018
- Primary completion31 Dec 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indication for Prostate Biopsy Due to Suspected 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProteoMediX AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Steuber, Prof. Dr., Principal investigator, Martiniklinik am UKE gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565289
- Sponsor's protocol ID
- PROPOSe_1
- Acronym
- PROPOSe
- Status last verified
- Dec 2020
- First submitted
- 7 Jun 2018
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRospective Prostate biOmarker Study (PROPOSe)
- ClinicalTrials.gov ID
- NCT03565289
- Acronym / sponsor ID
- PROPOSe / PROPOSe_1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- ProteoMediX AGIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 21 Jun 2018 (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.
- Correlation of a glycoprotein panel with prostate biopsy outcome and PCa aggressiveness
Detailed description
The main objective of this study is to correlate a glycoprotein panel with prostate biopsy outcome, i.e. distinguishing PCa from benign prostatic conditions as well as high-grade cancer. The quantities of the two protein analytes cathepsin D (CTSD) and thrombospondin 1 (THBS1) are measured in human serum samples. In combination with percent free PSA (%fPSA), the results are correlated with prostate biopsy outcome. The potential future benefit of using this glycoprotein panel is to validate positive tPSA tests in men with negative digital rectal examination (DRE) and enlarged prostates to reduce the need for undergoing a biopsy, thereby reducing unnecessary biopsies and potentially predicting high-grade disease.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Diagnostic Test: Blood sample collectionAll |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Patients with an indication for prostate biopsy at the participating sites.
Key inclusion criteria (6 listed)
- Male patient between 45 and 80 years old.
- tPSA between 2 and 10 ng/ml
- Prostate volume >=35 ml
- Non-suspicious DRE for prostate cancer
- Scheduled for prostate biopsy
Key exclusion criteria (6 listed)
- Patient not undergoing biopsy of the prostate
- Prior prostate biopsy within the last 12 months
- Transurethral resection of the prostate (TURP) in the last 5 years
- Patients with known acute or chronic prostatitis/cystitis or other known prostate abnormalities
- Patient taking 5-alpha-reductase inhibitor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collectionDuring a routine blood draw an additional tube of blood will be taken for the study. | Diagnostic test | All patients |
Primary outcome
Diagnosis of PCA
Time frame: 6 months
Correlation of the glycoprotein panel algorithm with histological diagnosis of PCa
Aggressiveness of PCA
Time frame: 6 months
Correlation of the glycoprotein panel algorithm with diagnosis of significant (Gleason Score ≥7) PCa
Diagnosis of PCA
Time frame: 12 months
Correlation of the glycoprotein panel algorithm with histological diagnosis of PCa
Aggressiveness of PCA
Time frame: 12 months
Correlation of the glycoprotein panel algorithm with diagnosis of significant (Gleason Score ≥7) PCa
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Thomas Steuber, Prof. Dr. principal investigator
Martiniklinik am UKE gGmbH
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Indication for Prostate Biopsy Due to Suspected Prostate Cancer, run by ProteoMediX AG at 11 sites in 3 countries.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Austria, Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of PCA (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2020.