Technology-Enhanced Acceleration of Germline Evaluation for Therapy, TARGET Study
Completed · Not applicable
Conditions studied: Biochemically Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8
In brief
This trial performs user testing of a mobile-friendly patient history collection and genetic education tool to improve healthcare providers' understanding of prostate cancer genetic testing. This trial also compares traditional genetic counseling versus a web-based genetic education (WBGE) tool to provide information about genetic testing to men with prostate cancer. The WBGE tool has educational modules on genetic counseling and testing, as well as a patient history collection tool to help providers learn which patients may carry genetic mutations and may be considered for genetic counseling and genetic testing. The purpose of this research is to use technology to deliver information on genetic testing for prostate cancer to patients to help them decide whether or not to receive genetic testing.
Key facts
- Study ID
- NCT04447703
- Run by
- Thomas Jefferson University
- People needed
- 346
- Starts
- 2020-08-27
- Expected to finish
- 2024-09-10
- Last updated by the study team
- 2025-12-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- AIM 1: Medical oncologists, radiation oncologists and urologists spanning Veterans Affairs (VA), academic, and community settings
- AIM 2: Any English speaking man >= 18 with PCA who has computer and web-access and meets any one of the following:
- Metastatic disease
- T3a or higher
- Prostate specific antigen (PSA) > 20
- Grade group 4 or higher
- Intraductal or cribriform histology
- Biochemical recurrence
- Ashkenazi Jewish ancestry
- Family history criteria (see below) ** Family history: If any one of the following levels are met, the person is eligible:
- Level 1: >= 1 close blood relative (first degree relative [FDR], second degree relative [SDR], third degree relative [TDR]) diagnosed with breast cancer =< age 50 or the following cancers at any age: pancreatic, ovarian, or metastatic or intraductal/cribriform prostate cancer
- Level 2: >= 2 close blood relatives (FDR, SDR, TDR) on same side of the family with breast or prostate cancer at any age
- Level 3: one brother, father, or >= 2 family members (close blood relatives - FDR, SDR, TDR) on the same side of the family diagnosed with prostate cancer at < 60
- Level 4: >= 3 cancers on the same side of the family (especially if diagnosed =< 50): bile duct, breast, colorectal, endometrial, gastric, kidney, melanoma, ovarian, pancreatic, prostate (grade groups 2-5 if known), small bowel, or urothelial
You may not qualify if…
- Age < 18 years
- Mental or cognitive impairment that interferes with ability to provide informed consent
- Non-English speaking
- Having had prior germline genetic testing for inherited cancer risk (pertains to aim 2)
Where it is running
- VA New York Harbor Health System- Manhattan Campus — New York, New York, United States
- New York University- Langone Health — New York, New York, United States
- Associated Medical Professions of New York — Syracuse, New York, United States
- Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania, United States
- University of Washington/ SCCA — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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