RegisterPROS - a Registry for Prostate Cancers

NCT ID: NCT06872619

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2030-12-15

Brief 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). 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.

1. 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:

2. 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:

1. Descriptive statistical analyses including demographics, histology and grading, treatment types.

2. Clinical follow-up and blood chemistry (PSA) and molecular results.

3. 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; PSA

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

PROSTest

Intervention Type: DEVICE

Multianalyte Algorithm Analysis of circulating prostate cancer transcripts

Interventions

PROSTest

Multianalyte Algorithm Analysis of circulating prostate cancer transcripts

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• All subjects

Exclusion Criteria

• Female

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Münster University Hospital, Germany

UNKNOWN

Sponsor Role: collaborator

Wren Laboratories LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abdel Halim, PhD, PharmD

Role: STUDY_DIRECTOR

Wren Laboratories

Kambiz Rahbar, MD

Role: PRINCIPAL_INVESTIGATOR

Munster University Hospital

Locations

University Hospital Munster

Münster, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 38571290 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 39121520 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 39838708 (View on PubMed)

Other Identifiers

WREN_REGISTER_02

Identifier Type: -

Identifier Source: org_study_id