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Biochemically Recurrent Prostate CarcinomaNCT04447703

Technology-Enhanced Acceleration of Germline Evaluation for Therapy, TARGET Study

A study testing Interview, Internet Based Intervention and Survey Administration in people with Biochemically Recurrent Prostate Carcinoma and Metastatic Prostate Carcinoma, run by Thomas Jefferson University at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Interview, Internet Based Intervention and Survey Administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
346 participants
Where
5 sitesUnited States
Study dates
27 Aug 2020to 10 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • VA New York Harbor Health System- Manhattan Campus

    New York, New York, 10010

  • New York University- Langone Health

    New York, New York, 10016

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • University of Washington/ SCCA

    Seattle, Washington, 98109

  • Associated Medical Professions of New York

    Syracuse, New York, 13210

Other trials in United States

About this study

Official title: Technology-Enhanced Acceleration of Germline Evaluation for Therapy - The TARGET Study

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Perform user-testing of an education and patient history collection mobile tool among medical oncologists, radiation oncologists, and urologists across study practice settings, including Veterans Affairs to address genetic referral needs (n=10 providers). (Provider-focused) II. Develop multimedia web-based pretest genetic education (WBGE) tool and conduct a randomized trial of traditional genetic counseling (GC) (Arm 1) versus (vs.) WBGE (Arm 2) for informed and timely uptake of genetic testing for men with lethal/predicted lethal prostate cancer (PCA). (Patient-focused)

OUTLINE:

AIM I: 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.

AIM II: Patients are randomized to 1 of 2 arms.

ARM I (TRADITIONAL GENETIC COUNSELING): 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.

ARM II (WEB-BASED GENETIC EDUCATION): Patients receive a link to the web-based genetic education tool online including all elements of genetic counseling in written modules and in a series of professional videos. Patients may then undergo genetic testing. Patients may cross-over to Arm I to see a genetic counselor.

After the completion of study, patients are followed up yearly for up to 5 years.

Being tested
Interview, Internet Based Intervention, Survey Administration, Genetic Counseling, Genetic Testing
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterviewOther

    Attend Interview

  • Internet Based InterventionOther

    Use web-based genetic education tool online

  • Survey AdministrationOther

    Ancillary Studies

  • Genetic CounselingOther

    Receive in-person, telehealth, or over-the-phone genetic counseling

  • Genetic TestingGenetic

    Also called Genetic Analysis, Genetic Examination, Genetic Test, Genetic Testing, Genetic Testing

    Undergo genetic testing

  • Survey AdministrationOther

    Ancillary Studies

  • Genetic CounselingOther

    Receive in-person, telehealth, or over-the-phone genetic counseling

  • Internet-Based InterventionOther

    Use web-based genetic education tool online

  • Genetic TestingGenetic

    Also called Genetic Analysis, Genetic Examination, Genetic Test, Genetic Testing, Genetic Testing

    Undergo genetic testing

  • Survey AdministrationOther

    Ancillary Studies

Study groups in NCT04447703
Study groupRoleWhat they receive
Aim I (Interview)ExperimentalProviders 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.
Receives: Other: Interview; Other: Internet Based Intervention; Other: Survey Administration
Aim II: Arm I (Genetic Counseling, Genetic Testing)Active comparatorPatients 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.
Receives: Other: Genetic Counseling; Genetic: Genetic Testing; Other: Survey Administration
Aim II: Arm II (WBGE, Genetic Couseling, Genetic Testing)ExperimentalPatients receive a link to the web-based genetic education tool online including all elements of genetic counseling in written modules and in a series of professional videos. Patient may then undergo genetic testing. Patient may cross-over to Arm I to see a genetic counselor.
Receives: Other: Genetic Counseling; Other: Internet-Based Intervention; Genetic: Genetic Testing; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. User Testing of the Provider Tool - (Aim I)

    Provider perspectives will include: (1) whether the target population can use the tool in the way it was intended (i.e., to perform patient history collection to determine consideration for germline testing), and (2) interaction with this tool affects the user's cognitive representation of genetic testing for prostate cancer (PCA). To evaluate the first point, will collect initial information from participants regarding their experience with the guidelines for genetic testing and how they collect data on family history. Will evaluate participants' mental model for germline testing and how they identify suitable candidates before interaction with the tool. Will use a cognitive concept mapping technique, which can be used to formalize a person's cognitive representation for complex topics. Feedback from this testing will be used to iteratively refine the tool while it is being used by providers to identify patients randomized trial in Aim II.

    Measured: Up to 6 months

  2. Decisional Conflict (Aim II)

    Will be assessed for non-inferiority between study arms. Evaluated using the O'Connor decisional conflict scale, which captures sub-scores over 16-questions for uncertainty, feeling of being informed, values clarity, support, and effective decision making on a 5-point Likert scale

    Measured: Up to 6 months

Secondary outcomes (3)

  1. Cancer Genetics Knowledge (Aim II)

    Assessed using pre- and post-intervention surveys. Cancer genetics knowledge will be adapted from Erblich. et al (2005) for relevance to PCA genetics (23 True/False questions) (Cronbach's alpha = 0.92).

    Measured: Up to 6 Months

  2. Genetic Testing Uptake (Aim II)

    Assessed using pre-and post-intervention surveys

    Measured: Up to 5 years

  3. Satisfaction with Genetic Counseling or Web-Based Genetic Education (Aim II)

    Will capture men's satisfaction with each arm using the Satisfaction with Genetic Counseling Scale at the end of pre-test genetic counseling or after viewing the web tool. This 6-item scale includes questions such as: "My genetic counselor seemed to understand the stresses I was facing," and "The genetic counseling session was valuable to me" rated on a 5-point Likert scale (Cronbach's alpha 0.7-0.88). The questions will be adapted for web-based pretest genetic education such as "This webtool addressed all of the concerns I had" or "The webtool was valuable to me".

    Measured: After viewing the web tool

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2020
  2. Study start27 Aug 2020
  3. Primary completion9 Aug 2022
  4. Study completion10 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
346 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04447703
Sponsor's protocol ID
20G.013
Other IDs
19CHAL05, JT 14902
Status last verified
Nov 2025
First submitted
23 Apr 2020
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Loeb 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.

    PubMed 38452310

  • Loeb 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.

    PubMed 35710085

Questions about this trial

What is this clinical trial studying?

A study testing Interview, Internet Based Intervention and Survey Administration in people with Biochemically Recurrent Prostate Carcinoma and Metastatic Prostate Carcinoma, run by Thomas Jefferson University at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

User Testing of the Provider Tool - (Aim I) (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04447703, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.

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