NCT05958082

Brief Summary

This is a pilot study to improve rates of germline genetic testing for black patients with aggressive prostate cancer as recommended by the updated guidelines by the National Cancer Comprehensive Network (NCCN) in 2018. In this study, consented patients will undergo a low-risk intervention of an educational session with a trained staff member on germline testing in prostate cancer and, if agreeable, subsequent germline cancer genetic testing via a commercial lab test.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
7mo left

Started Jan 2025

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 Progress70%
Jan 2025Dec 2026

First Submitted

Initial submission to the registry

July 7, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

July 7, 2023

Last Update Submit

January 14, 2026

Conditions

Prostate Cancer

Keywords

genetic testing

Outcome Measures

Primary Outcomes (1)

  • Testing rate

    percentage of patients who undergo genetic testing after completing the education session

    24 months

Secondary Outcomes (3)

  • Baseline knowledge per "Patient Survey on Germline Testing in Prostate Cancer" questionnaire

    Day 1, before intervention

  • Post-intervention knowledge per "Patient Post-Education Patient Survey" questionnaire

    Day 1, after intervention

  • Clinician attitudes per "Post Results Clinician Questionnaire"

    24 months

Study Arms (1)

Educational intervention

EXPERIMENTAL

Patients will be asked questions about genetic testing for prostate cancer before and after an educational intervention.

Behavioral: Educational video

Interventions

Educational videoBEHAVIORAL

The educational intervention will occur with a clinical research coordinator who will be trained to educate on germline testing in prostate cancer.

Educational intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men, age greater than or equal to 18 years of age.
  • Men who racially identify as black or multiracial including black
  • Diagnosis of prostate cancer of any histology.
  • Must meet NCCN guidelines for germline testing
  • Men with very low, low or intermediate risk prostate per NCCN guidelines with a positive family history or intraductal histology. Family history here is considered significant if the patient has:
  • a first degree relative with prostate cancer or more than one first/second degree relative with prostate cancer, or
  • ≥3 cancers on same side of family, especially diagnoses ≤50 years of age: bile duct, breast, colorectal, endometrial, gastric, kidney, melanoma, ovarian, pancreatic, prostate (but not clinically localized Grade Group 1), small bowel, or urothelial cancer
  • Men with high-risk, very-high risk (per NCCN definitions of risk groups), lymph node positive, or metastatic prostate cancer independent of family history of histology.

You may not qualify if:

  • Have had prior germline testing.
  • Have somatic genetic testing that is positive for a possible germline variant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Cancer Pavilion

Detroit, Michigan, 48202, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Clara Hwang, MD

CONTACT

313-556-8830chwang2@hfhs.org

Karthik Subramanian, MS

CONTACT

313-401-9815ksubram3@hfhs.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Assistant Professor

Study Record Dates

First Submitted

July 7, 2023

First Posted

July 24, 2023

Study Start

January 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)