RegisterPROS - a Registry for Prostate Cancers

NCT06872619 | Enrolling By Invitation

• 1 other identifier: WREN_REGISTER_02
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer (Adenocarcinoma); Prostate Biopsy; Prostatectomy; Radioligand; Chemotherapy; Androgen Deprivation Therapy; PSA

Outcome Measures

Primary Outcomes (2)

• PCa diagnosis

  Histology confirmed prostate cancer disease

  5 years

• Surveillance

  Natural progression of disease

  10 years

Secondary Outcomes (2)

• Minimal residual disease

  10 years

• Therapy efficacy

  10 years

Study Arms (1)

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

Device: PROSTest

Interventions

PROSTest DEVICE

Multianalyte Algorithm Analysis of circulating prostate cancer transcripts

Prostate cancer subjects

Eligibility Criteria

• Age: 45 Years - 100 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a histologically confirmed diagnosis of a prostate cancer

You may qualify if:

• All subjects

You may not qualify if:

• Female

Sponsors & Collaborators

• Wren Laboratories LLC: lead
• Münster University Hospital, Germany: collaborator

Study Sites (1)

University Hospital Munster

Münster, Germany

Location

Related Publications (3)

• 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.

  PMID: 38571290 BACKGROUND

• 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.

  PMID: 39121520 BACKGROUND

• 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.

  PMID: 39838708 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood collection (RNA stabilization tube) used for prostate cancer biomarker measurements

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Abdel Halim, PhD, PharmD

  Wren Laboratories

  STUDY DIRECTOR

• Kambiz Rahbar, MD

  Munster University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 12, 2025
• Study Start: January 15, 2020
• Primary Completion: December 15, 2025
• Study Completion (Estimated): December 15, 2030
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)