Status:
COMPLETED
Technology-Enhanced Acceleration of Germline Evaluation for Therapy, TARGET Study
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
Prostate Cancer Foundation
Conditions:
Biochemically Recurrent Prostate Carcinoma
Metastatic Prostate Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 tria...
Detailed Description
PRIMARY OBJECTIVES: I. Perform user-testing of an education and patient history collection mobile tool among medical oncologists, radiation oncologists, and urologists across study practice settings,...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- Exclusion Criteria
- 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)
Exclusion
Key Trial Info
Start Date :
August 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2024
Estimated Enrollment :
346 Patients enrolled
Trial Details
Trial ID
NCT04447703
Start Date
August 27 2020
End Date
September 10 2024
Last Update
December 2 2025
Active Locations (5)
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1
VA New York Harbor Health System- Manhattan Campus
New York, New York, United States, 10010
2
New York University- Langone Health
New York, New York, United States, 10016
3
Associated Medical Professions of New York
Syracuse, New York, United States, 13210
4
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107