RegisterPROS - A Registry for Prostate Cancers (RegisterPROS)
A Registry for Prostate Cancers
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Münster, Germany
- University Hospital Munster
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All subjects
Exclusion Criteria:
- Female
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
Multianalyte Algorithm Analysis of circulating prostate cancer transcripts
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PCa diagnosis
Time Frame: 5 years
|
Histology confirmed prostate cancer disease
|
5 years
|
|
Surveillance
Time Frame: 10 years
|
Natural progression of disease
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Minimal residual disease
Time Frame: 10 years
|
Detection of MRD
|
10 years
|
|
Therapy efficacy
Time Frame: 10 years
|
Treatment response assessment
|
10 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Abdel Halim, PhD, PharmD, Wren Laboratories
- Principal Investigator: Kambiz Rahbar, MD, Munster University Hospital
Publications and helpful links
General 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.
- Rosin 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.
- Rahbar 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.
- Rahbar 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WREN_REGISTER_02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.