NCT04052048

Brief Summary

A multi-center, prospective active surveillance registry trial assessing the performance of a non-invasive blood test for indolent prostate cancer disease management.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
41mo left

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Sep 2019Sep 2029

First Submitted

Initial submission to the registry

August 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 9, 2019

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2026

Expected
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2029

Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

7.2 years

First QC Date

August 7, 2019

Last Update Submit

March 29, 2026

Conditions

Prostate Cancer Aggressiveness

Outcome Measures

Primary Outcomes (1)

  • Collect performance results on assay's ability to identify occult aggressive disease in active surveillance population.

    Collect information from repeat biopsy including any increase in gleason grade, increase in number of cores positive, and increase in % cross sectional surface area involved by tumor from the repeat biopsy.

    1 year

Secondary Outcomes (1)

  • Validate immunogenomic assay's ability to serve as an ongoing, non-invasive tool to monitor patient risk for disease progression as detected by repeat biopsy.

    10 years

Interventions

Subtraction Normalized Expression of Phagocytes Blood TestDIAGNOSTIC_TEST

Non-invasive blood based immunogenomic assay that targets RNA sequencing to identify disease and disease aggressiveness

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men with prostate cancer who are on or are candidates for Active surveillance.

You may qualify if:

  • Men between 40-80 of age with at least a 10-year life expectancy
  • All active surveillance protocols are accepted
  • No PSA limits
  • Category 1:
  • Patient is currently on active surveillance with only ONE previous low grade prostate biopsy.
  • Patient must already be scheduled for their 1st annual biopsy under their active surveillance protocol within 90 days of enrollment date.
  • Category 2:
  • Patient is recently diagnosed with low grade prostate cancer but has decided against active surveillance and is scheduled for radical prostatectomy within 90 days of enrollment date.

You may not qualify if:

  • Men on watchful waiting i.e. those with less than 10-year life expectancy with no intent for curative therapy
  • Men with symptoms or rising PSA who have not been proven to have cancer by tissue biopsy i.e. men with only negative prostate biopsies.
  • Patients with a history of a different cancer (except basal cell carcinoma)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Urology

Royal Oak, Michigan, 48197, United States

RECRUITING

Related Publications (11)

  • Palmer C, Diehn M, Alizadeh AA, Brown PO. Cell-type specific gene expression profiles of leukocytes in human peripheral blood. BMC Genomics. 2006 May 16;7:115. doi: 10.1186/1471-2164-7-115.

    PMID: 16704732BACKGROUND

  • Schmidl C, Renner K, Peter K, Eder R, Lassmann T, Balwierz PJ, Itoh M, Nagao-Sato S, Kawaji H, Carninci P, Suzuki H, Hayashizaki Y, Andreesen R, Hume DA, Hoffmann P, Forrest AR, Kreutz MP, Edinger M, Rehli M; FANTOM consortium. Transcription and enhancer profiling in human monocyte subsets. Blood. 2014 Apr 24;123(17):e90-9. doi: 10.1182/blood-2013-02-484188. Epub 2014 Mar 26.

    PMID: 24671955BACKGROUND

  • Hashimoto S, Nagai S, Sese J, Suzuki T, Obata A, Sato T, Toyoda N, Dong HY, Kurachi M, Nagahata T, Shizuno K, Morishita S, Matsushima K. Gene expression profile in human leukocytes. Blood. 2003 May 1;101(9):3509-13. doi: 10.1182/blood-2002-06-1866. Epub 2003 Jan 9.

    PMID: 12522010BACKGROUND

  • Dale DC, Boxer L, Liles WC. The phagocytes: neutrophils and monocytes. Blood. 2008 Aug 15;112(4):935-45. doi: 10.1182/blood-2007-12-077917.

    PMID: 18684880BACKGROUND

  • Gutknecht MF, Bouton AH. Functional significance of mononuclear phagocyte populations generated through adult hematopoiesis. J Leukoc Biol. 2014 Dec;96(6):969-80. doi: 10.1189/jlb.1RI0414-195R. Epub 2014 Sep 15.

    PMID: 25225678BACKGROUND

  • Chow A, Brown BD, Merad M. Studying the mononuclear phagocyte system in the molecular age. Nat Rev Immunol. 2011 Oct 25;11(11):788-98. doi: 10.1038/nri3087.

    PMID: 22025056BACKGROUND

  • Epstein JI. An update of the Gleason grading system. J Urol. 2010 Feb;183(2):433-40. doi: 10.1016/j.juro.2009.10.046. Epub 2009 Dec 14.

    PMID: 20006878BACKGROUND

  • Grignon DJ. Prostate cancer reporting and staging: needle biopsy and radical prostatectomy specimens. Mod Pathol. 2018 Jan;31(S1):S96-109. doi: 10.1038/modpathol.2017.167.

    PMID: 29297497BACKGROUND

  • Boutros PC, Fraser M, Harding NJ, de Borja R, Trudel D, Lalonde E, Meng A, Hennings-Yeomans PH, McPherson A, Sabelnykova VY, Zia A, Fox NS, Livingstone J, Shiah YJ, Wang J, Beck TA, Have CL, Chong T, Sam M, Johns J, Timms L, Buchner N, Wong A, Watson JD, Simmons TT, P'ng C, Zafarana G, Nguyen F, Luo X, Chu KC, Prokopec SD, Sykes J, Dal Pra A, Berlin A, Brown A, Chan-Seng-Yue MA, Yousif F, Denroche RE, Chong LC, Chen GM, Jung E, Fung C, Starmans MH, Chen H, Govind SK, Hawley J, D'Costa A, Pintilie M, Waggott D, Hach F, Lambin P, Muthuswamy LB, Cooper C, Eeles R, Neal D, Tetu B, Sahinalp C, Stein LD, Fleshner N, Shah SP, Collins CC, Hudson TJ, McPherson JD, van der Kwast T, Bristow RG. Spatial genomic heterogeneity within localized, multifocal prostate cancer. Nat Genet. 2015 Jul;47(7):736-45. doi: 10.1038/ng.3315. Epub 2015 May 25.

    PMID: 26005866BACKGROUND

  • Womble PR, Montie JE, Ye Z, Linsell SM, Lane BR, Miller DC; Michigan Urological Surgery Improvement Collaborative. Contemporary use of initial active surveillance among men in Michigan with low-risk prostate cancer. Eur Urol. 2015 Jan;67(1):44-50. doi: 10.1016/j.eururo.2014.08.024. Epub 2014 Aug 24.

    PMID: 25159890BACKGROUND

  • Cher ML, Dhir A, Auffenberg GB, Linsell S, Gao Y, Rosenberg B, Jafri SM, Klotz L, Miller DC, Ghani KR, Bernstein SJ, Montie JE, Lane BR; Michigan Urological Surgery Improvement Collaborative. Appropriateness Criteria for Active Surveillance of Prostate Cancer. J Urol. 2017 Jan;197(1):67-74. doi: 10.1016/j.juro.2016.07.005. Epub 2016 Jul 14.

    PMID: 27422298BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Three tubes of blood: Two 8ml CPT One 4ml SST Prostate Biopsy slides

MeSH Terms

Conditions

Prostate Cancer, Hereditary, 7

Central Study Contacts

Jessica DeHart

CONTACT

619-316-1416jessica.dehart@oncocellmdx.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 9, 2019

Study Start

September 9, 2019

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

September 30, 2029

Last Updated

April 2, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)