Prostate Cancer (Adenocarcinoma)RegisterPROSNCT06872619
RegisterPROS - A Registry for Prostate Cancers
An observational study of Prostate Cancer (Adenocarcinoma) and Prostate Biopsy, run by Wren Laboratories LLC at 1 site in Germany.
Trial summary
Prostate cancers are derived from epithelial cells in the prostate gland. Treatment options include surgery, medical (androgen signaling targeted and chemotherapy) and radiation therapy including radioligand therapy (RLT). Read more about this study
- Who is it for?
- Ages 45 to 100 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma), Prostate Biopsy, Prostatectomy
- What is being tested?
- PROSTest
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jan 2020to 15 Dec 2030
- 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 45 to 100 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with a histologically confirmed diagnosis of a prostate cancer
Who may be able to join
- All subjects
Who cannot join
- Female
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Registry for Prostate Cancers
Prostate cancers are derived from epithelial cells in the prostate gland. Treatment options include surgery, medical (androgen signaling targeted and chemotherapy) and radiation therapy including radioligand therapy (RLT). Survival is linked to early and accurate diagnoses or to the effective detection of disease recurrence and/or treatment failure. One challenge is to develop accurate non-invasive tests that can detect prostate cancer disease activity. A second challenge is to evaluate the effectiveness of such biomarkers during the natural history of this disease (e.g., active surveillance). A third aim is to identify whether molecular markers can predict response to different therapies (either pre-treatment, or early on during the first few cycles of a therapy). RegisterPROS registry aims at collecting data and blood samples from patients being evaluated for PCa disease. Data will be entered prospectively and anonymized after informed consent. All physicians who treat PCas are invited to participate to the registry. Data will be evaluated within regular time frames, focusing on diagnostic accuracy for biomarkers in the different types of tumors, treatment modalities and patient outcomes (e.g. disease recurrence and survival), thereby contributing to an understanding of the role of biomarkers in tumor management.
Read the detailed description
Background: Survival of PCas is linked to early and accurate diagnoses of aggressive disease (GG2-5) and effective detection of disease progression and/or recurrence (minimal residual disease or treatment failure). Tissue based molecular markers have been developed and have utility (e.g., OncoType Dx). Blood-based markers e.g., ARV-7 detection may also have utility. However, PSA (and changes in levels from baseline) are considered the current standard of care. Molecular markers e.g., PROSTest, have been developed but little is known about the utility of these markers in clinical practice. Objective: To systematically and prospectively collect clinical information and samples (blood and saliva) from PCas in Europe, Africa, Caribbean and the USA based a histologically confirmed diagnosis. Methods: PCas will be enrolled and followed up following informed consent. Data will be entered prospectively and anonymized. Patient history are completed by contributing physicians and samples are collected for analysis. All information will be transferred to a database. Evaluation of treatment modalities and patient outcomes (e.g. disease recurrence) will be assessed at follow-up times. The primary objectives of the project are to:
1a) assess diagnostic accuracy of molecular-based blood tests e.g., PROSTest.
- b) evaluate utility of molecular-based tests e.g., PROSTest to monitor PCa patients (active surveillance or on treatment). The secondary objectives of the project include:
- a) assess utility of molecular-based tools to detect disease recurrence
2b) examine whether these tools can predict response to different therapies
Analyses will include:
- Descriptive statistical analyses including demographics, histology and grading, treatment types.
- Clinical follow-up and blood chemistry (PSA) and molecular results.
- Correlation analyses between blood results and clinical data. This will include assessment of the time at which the results significantly (and consistently) increases and the time of tumor recurrence and an evaluation whether the change in blood results is predictive of disease recurrence and/or treatment efficacy.
- Conditions
- Prostate Cancer (Adenocarcinoma), Prostate Biopsy, Prostatectomy, Radioligand, Chemotherapy, Androgen Deprivation Therapy
- Being tested
- PROSTest
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROSTestDevice
Multianalyte Algorithm Analysis of circulating prostate cancer transcripts
| Study group | Role | What they receive |
|---|---|---|
| Prostate cancer subjects | Subjects at risk or who have a histological confirmation of prostate cancer disease (all Gleason grades, all stages including castration resistant disease). Interventions include ADT, chemotherapy and RLT Receives: Device: PROSTest |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCa diagnosis
Histology confirmed prostate cancer disease
Measured: 5 years
Surveillance
Natural progression of disease
Measured: 10 years
Secondary outcomes (2)
Minimal residual disease
Detection of MRD
Measured: 10 years
Therapy efficacy
Treatment response assessment
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start15 Jan 2020
- Primary completion15 Dec 2028 (estimated)
- Study completion15 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wren Laboratories LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital Muenster
- Responsible party
- Sponsor
- Investigators
- Abdel Halim, PhD, PharmD, Study director, Wren LaboratoriesKambiz Rahbar, MD, Principal investigator, Munster University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872619
- Sponsor's protocol ID
- WREN_REGISTER_02
- Acronym
- RegisterPROS
- Status last verified
- Aug 2026
- First submitted
- 6 Mar 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Modlin IM, Kidd M, Drozdov IA, Boegemann M, Bodei L, Kunikowska J, Malczewska A, Bernemann C, Koduru SV, Rahbar K. Development of a multigenomic liquid biopsy (PROSTest) for prostate cancer in whole blood. Prostate. 2024 Jun;84(9):850-865. doi: 10.1002/pros.24704. Epub 2024 Apr 3.
PubMed 38571290Rosin RD, Haynes A, Kidd M, Drozdov I, Modlin I, Halim A. Evaluation of a multigenomic liquid biopsy (PROSTest) for prostate cancer detection and follow-up in a Caribbean population. Cancer Epidemiol. 2024 Oct;92:102642. doi: 10.1016/j.canep.2024.102642. Epub 2024 Aug 9.
PubMed 39121520Rahbar K, Kidd M, Prasad V, David Rosin R, Drozdov I, Halim A. Clinical Sensitivity and Specificity of the PROSTest in an American Cohort. Prostate. 2025 May;85(6):558-566. doi: 10.1002/pros.24858. Epub 2025 Jan 21.
PubMed 39838708Rahbar K, Schlack K, Bogemann M. Utility of the prostest to predict and monitor response to chemotherapy in metastatic Castration-Resistant prostate cancer: A prospective pilot study. BMC Cancer. 2025 Jul 10;25(1):1159. doi: 10.1186/s12885-025-14549-3.
PubMed 40640763
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry for Prostate Cancers
- ClinicalTrials.gov ID
- NCT06872619
- Acronym / sponsor ID
- RegisterPROS / WREN_REGISTER_02
- Conditions
- Prostate Cancer (Adenocarcinoma), Prostate Biopsy, Prostatectomy, Radioligand, Chemotherapy, Androgen Deprivation Therapy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Wren Laboratories LLCIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital Muenster
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Dec 2028 (estimated)
- Study completion
- 15 Dec 2030 (estimated)
- First posted
- 12 Mar 2025 (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.
Prostate cancers are derived from epithelial cells in the prostate gland. Treatment options include surgery, medical (androgen signaling targeted and chemotherapy) and radiation therapy including radioligand therapy (RLT). Survival is linked to early and accurate diagnoses or to the effective detection of disease recurrence and/or treatment failure. One challenge is to develop accurate non-invasive tests that can detect prostate cancer disease activity. A second challenge is to evaluate the effectiveness of such biomarkers during the natural history of this disease (e.g., active surveillance). A third aim is to identify whether molecular markers can predict response to different therapies (either pre-treatment, or early on during the first few cycles of a therapy). RegisterPROS registry aims at collecting data and blood samples from patients being evaluated for PCa disease. Data will be entered prospectively and anonymized after informed consent. All physicians who treat PCas are invited to participate to the registry. Data will be evaluated within regular time frames, focusing on diagnostic accuracy for biomarkers in the different types of tumors, treatment modalities and patient outcomes (e.g. disease recurrence and survival), thereby contributing to an understanding of the role of biomarkers in tumor management.
Detailed description
Background: Survival of PCas is linked to early and accurate diagnoses of aggressive disease (GG2-5) and effective detection of disease progression and/or recurrence (minimal residual disease or treatment failure). Tissue based molecular markers have been developed and have utility (e.g., OncoType Dx). Blood-based markers e.g., ARV-7 detection may also have utility. However, PSA (and changes in levels from baseline) are considered the current standard of care. Molecular markers e.g., PROSTest, have been developed but little is known about the utility of these markers in clinical practice. Objective: To systematically and prospectively collect clinical information and samples (blood and saliva) from PCas in Europe, Africa, Caribbean and the USA based a histologically confirmed diagnosis. Methods: PCas will be enrolled and followed up following informed consent. Data will be entered prospectively and anonymized. Patient history are completed by contributing physicians and samples are collected for analysis. All information will be transferred to a database. Evaluation of treatment modalities and patient outcomes (e.g. disease recurrence) will be assessed at follow-up times. The primary objectives of the project are to:
1a) assess diagnostic accuracy of molecular-based blood tests e.g., PROSTest.
- b) evaluate utility of molecular-based tests e.g., PROSTest to monitor PCa patients (active surveillance or on treatment). The secondary objectives of the project include:
- a) assess utility of molecular-based tools to detect disease recurrence
2b) examine whether these tools can predict response to different therapies
Analyses will include:
- Descriptive statistical analyses including demographics, histology and grading, treatment types.
- Clinical follow-up and blood chemistry (PSA) and molecular results.
- Correlation analyses between blood results and clinical data. This will include assessment of the time at which the results significantly (and consistently) increases and the time of tumor recurrence and an evaluation whether the change in blood results is predictive of disease recurrence and/or treatment efficacy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate cancer subjects | – | Device: PROSTestSubjects at risk or who have a histological confirmation of prostate cancer disease (all Gleason grades, all stages including castration resistant disease). Interventions include ADT, chemotherapy and RLT |
Who may qualify
- Ages
- 45 to 100 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a histologically confirmed diagnosis of a prostate cancer
Key inclusion criteria (1 listed)
- All subjects
Key exclusion criteria (1 listed)
- Female
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 |
|---|---|---|
| PROSTestMultianalyte Algorithm Analysis of circulating prostate cancer transcripts | Device | Prostate cancer subjects |
Primary outcome
PCa diagnosis
Time frame: 5 years
Histology confirmed prostate cancer disease
Surveillance
Time frame: 10 years
Natural progression of disease
2 secondary outcomes
Minimal residual disease
Time frame: 10 years
Therapy efficacy
Time frame: 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 21 Aug 2026.
- Background: PubMed 38571290Modlin IM, Kidd M, Drozdov IA, Boegemann M, Bodei L, Kunikowska J, Malczewska A, Bernemann C, Koduru SV, Rahbar K. Development of a multigenomic liquid biopsy (PROSTest) for prostate cancer in whole blood. Prostate. 2024 Jun;84(9):850-865. doi: 10.1002/pros.24704. Epub 2024 Apr 3.
- Background: PubMed 39121520Rosin RD, Haynes A, Kidd M, Drozdov I, Modlin I, Halim A. Evaluation of a multigenomic liquid biopsy (PROSTest) for prostate cancer detection and follow-up in a Caribbean population. Cancer Epidemiol. 2024 Oct;92:102642. doi: 10.1016/j.canep.2024.102642. Epub 2024 Aug 9.
- Background: PubMed 39838708Rahbar K, Kidd M, Prasad V, David Rosin R, Drozdov I, Halim A. Clinical Sensitivity and Specificity of the PROSTest in an American Cohort. Prostate. 2025 May;85(6):558-566. doi: 10.1002/pros.24858. Epub 2025 Jan 21.
- Derived from this study: PubMed 40640763Rahbar K, Schlack K, Bogemann M. Utility of the prostest to predict and monitor response to chemotherapy in metastatic Castration-Resistant prostate cancer: A prospective pilot study. BMC Cancer. 2025 Jul 10;25(1):1159. doi: 10.1186/s12885-025-14549-3.
- 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.
Abdel Halim, PhD, PharmD study director
Wren Laboratories
Kambiz Rahbar, MD principal investigator
Munster University Hospital
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 (Adenocarcinoma) and Prostate Biopsy, run by Wren Laboratories LLC 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 21 Aug 2026. 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?
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?
PCa diagnosis (time frame: 5 years). The study lists 2 primary outcomes in all. 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 NCT06872619, which also lists 4 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 21 Aug 2026.