Clinical trial · Interventional
Technology-Enhanced Acceleration of Germline Evaluation for Therapy, TARGET Study
Technology-Enhanced Acceleration of Germline Evaluation for Therapy - The TARGET Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biochemically Recurrent Prostate Carcinoma | — | UNRESOLVED | — |
| Metastatic Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIIB Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Genetic Counseling | Other | — | UNRESOLVED |
| Genetic Testing | Genetic | — | UNRESOLVED |
| Internet Based Intervention | Other | — | UNRESOLVED |
| Interview | Other | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Aim I (Interview)
- description
- Providers attend an interview over 1 hour to discuss how they would use the tool, then receive the tool to test in their clinic for 2 weeks. After 2 weeks, providers discuss their experience using the tool over 10-15 minutes. Providers have the option to use the tool for up to 6 months and complete a brief survey about the benefits and limitations of the tool for patient identification in Arm II.
- interventionNames
- Other: Interview
- Other: Internet Based Intervention
- Other: Survey Administration
- type
- ACTIVE_COMPARATOR
- label
- Aim II: Arm I (Genetic Counseling, Genetic Testing)
- description
- Patients receive genetic counseling with a certified genetic counselor in-person, by telehealth, or over the phone (according to patient preference). Patients may then undergo genetic testing.
- interventionNames
- Other: Genetic Counseling
- Genetic: Genetic Testing
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)References
Publications (2)
- DERIVEDLoeb S, Keith SW, Cheng HH, Leader AE, Gross L, Sanchez Nolasco T, Byrne N, Hartman R, Brown LH, Pieczonka CM, Gomella LG, Kelly WK, Lallas CD, Handley N, Mille PJ, Mark JR, Brown GA, Chopra S, McClellan A, Wise DR, Hollifield L, Giri VN. TARGET: A Randomized, Noninferiority Trial of a Pretest, Patient-Driven Genetic Education Webtool Versus Genetic Counseling for Prostate Cancer Germline Testing. JCO Precis Oncol. 2024 Mar;8:e2300552. doi: 10.1200/PO.23.00552. PMID 38452310
- DERIVEDLoeb S, Cheng HH, Leader A, Gross L, Nolasco TS, Byrne N, Wise DR, Hollifield L, Brown LH, Slater E, Pieczonka C, Gomella LG, Kelly WK, Trabulsi EJ, Handley N, Lallas CD, Chandrasekar T, Mille P, Mann M, Mark JR, Brown G, Chopra S, Wasserman J, Phillips J, Somers P, Giri VN. Technology-enhanced AcceleRation of Germline Evaluation for Therapy (TARGET): A randomized controlled trial of a pretest patient-driven webtool vs. genetic counseling for prostate cancer germline testing. Contemp Clin Trials. 2022 Aug;119:106821. doi: 10.1016/j.cct.2022.106821. Epub 2022 Jun 14. PMID 35710085