Clinical trial NCT06872619: RegisterPROS - a Registry for Prostate Cancers
Official title: A Registry for Prostate Cancers
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Prostate Cancer (Adenocarcinoma)
Prostate Biopsy
Prostatectomy
Radioligand
Chemotherapy
Androgen Deprivation Therapy
PSA
Lead sponsor: Wren Laboratories LLC
Sponsor class: INDUSTRY
Collaborators: name: Münster University Hospital, Germany
First posted: 2025-03-12
Enrollment: 1000
Sex: MALE
Minimum age (years): 45
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a histologically confirmed diagnosis of a prostate cancer

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.

Eligibility criteria: Inclusion Criteria:

* All subjects

Exclusion Criteria:

* Female

Primary outcomes:
measure: PCa diagnosis
timeFrame: 5 years
measure: Surveillance
timeFrame: 10 years
Secondary outcomes:
measure: Minimal residual disease
timeFrame: 10 years
measure: Therapy efficacy
timeFrame: 10 years
Other outcomes:
Locations:
city: Munster
country: Germany
facility: University Hospital Munster
Study officials:
affiliation: Wren Laboratories
name: Abdel Halim, PhD, PharmD
role: STUDY_DIRECTOR
affiliation: Munster University Hospital
name: Kambiz Rahbar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.