Counseling Tool for Prostate Cancer

Overseen By Daniel Avins

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Contraindication to study procedures

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the delivery of pre-tumor genetic testing counseling to Black or African American men with metastatic prostate cancer. Researchers are developing and testing a counseling tool, the Tumor Genomic Pre-test Counseling Tool, to make genetic testing information more accessible and equitable. The trial consists of two stages: first, gathering feedback to create the tool, and second, implementing the tool and evaluating its effectiveness. Men who identify as Black or African American and have metastatic prostate cancer may be suitable participants, especially if they anticipate discussions about genetic testing soon. As an unphased trial, this study offers participants the chance to help make genetic testing more accessible and equitable for their community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your healthcare provider.

What prior data suggests that this counseling tool is safe for use in pre-Tumor genetic testing?

Research has shown that genetic and genomic testing for prostate cancer is commonly used and well-integrated into patient care. These tests help doctors decide on the best treatment and assess cancer risk. The counseling tool in this trial ensures patients understand these tests before taking them.

While no direct evidence exists about the safety of the counseling tool itself, the trial focuses on education and understanding, not physical treatments or medications. Since the tool is not a drug or medical procedure, there are no physical side effects to consider.

This study is in the "Not Applicable" phase, meaning it does not test a new drug or medical device but rather an educational tool. Therefore, the usual safety concerns of drug trials do not apply. Participants will engage in interviews and surveys about the tool, which are safe activities. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to enhance prostate cancer care through a new counseling tool. Unlike the standard treatments that focus on addressing the cancer itself, this approach emphasizes pre-test education by using a Tumor Genomic Pre-test Counseling Tool. This tool is designed to provide personalized educational support, ensuring that patients better understand their genomic test results and potential treatment paths. By using insights from patient interviews and behavior change frameworks, the trial seeks to implement a more effective educational strategy, possibly leading to more informed decision-making and improved patient outcomes in prostate cancer care.

What evidence suggests that this counseling tool is effective for prostate cancer?

Research has shown that genetic testing is becoming a key part of prostate cancer care, helping to identify genetic changes that might influence treatment options. Studies indicate that genetic testing can guide treatment decisions for men with prostate cancer. One study found that 74% of patients underwent genetic testing, highlighting its growing use. In this trial, researchers are developing and testing the Tumor Genomic Pre-test Counseling Tool to make these benefits more accessible, especially for Black or African American men. Participants will engage in interviews and receive the counseling tool during different stages of the study. ^{1 2 3 4 6}

Who Is on the Research Team?

Daniel Kwon, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is specifically for Black or African-American men who have metastatic prostate cancer. It aims to improve the process of counseling before genetic testing related to their cancer.

Inclusion Criteria

Stage 1: Identifies as Black or African American, by either chart documentation or participant self-report. Mixed-race including Black or African American is included.

I have prostate cancer that has spread to other parts of my body.

I understand and can follow the study's procedures.

Exclusion Criteria

I have no health issues preventing me from undergoing study procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Tool Development

Participants engage in semi-structured interviews to develop the pre-test counseling tool

Up to 60 days

Interviews conducted via phone, video conference, or in-person

Tool Implementation

Participants use the developed tool and complete pre- and post-intervention surveys

Up to 60 days

Follow-up

Participants are monitored for tool effectiveness and undergo thematic analysis of interviews

Up to 90 days

What Are the Treatments Tested in This Trial?

Interventions

• Tumor Genomic Pre-test Counseling Tool

Trial Overview

The study is evaluating a new counseling tool designed for pre-tumor genomic testing in these patients. Participants will be asked to complete questionnaires as part of the assessment.

How Is the Trial Designed?

Group I: Stage 1: Tool Implementation (Pilot Study) Experimental Treatment 2 Interventions

Participants will receive the tumor genetic pre-test counseling tool informed by results and themes identified in Stage 1. Participants will receive the non-therapeutic intervention, a pre-TGT counseling tool, and complete pre- and post-intervention surveys and a attend a brief post-intervention interview.

Group II: Stage 1: Tool Development Experimental Treatment 2 Interventions

Participants will participate in a semi-structured qualitative interview either by phone, video conference or in-person. A trained interviewer will interview eligible, consenting participants using a semi-structured interview guide to meet objectives. The interview guide is based on The Patient Education Materials Assessment Tool (PEMAT) and the COM-B (capability (C), opportunity (O), and motivation (M))/Behaviour Change Wheel (BCW) framework and will be used to determine an implementation strategy. The interview will be audio-recorded, transcribed verbatim, and analyzed.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Prostate Cancer Foundation

Collaborator

Trials

52

Recruited

3,000+

Published Research Related to This Trial

Genetic counseling for prostate cancer is becoming essential, similar to its established role in other cancers like breast and colon cancer, due to the recognition of hereditary cancer syndromes associated with prostate cancer.

An interdisciplinary working group has developed a practical protocol for genetic counseling in prostate cancer, addressing who should receive counseling, which gene panels to analyze, and how to conduct counseling based on results, enhancing early detection and treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic counseling in prostate cancer: How to implement it in daily clinical practice? Borque-Fernando, A., Espílez, R., Miramar, D., et al.[2021]

In a study of 200 men, 5.5% were found to have mutations related to prostate cancer, primarily in DNA repair genes, indicating the potential for targeted therapies based on genetic profiles.

A family history of breast cancer was significantly linked to mutation status, suggesting that detailed family histories are crucial for identifying men who may benefit from genetic evaluation and personalized cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inherited Mutations in Men Undergoing Multigene Panel Testing for Prostate Cancer: Emerging Implications for Personalized Prostate Cancer Genetic Evaluation. Giri, VN., Obeid, E., Gross, L., et al.[2022]

Genetic testing plays a crucial role in guiding screening and treatment decisions for men with prostate cancer, which is one of the most common cancers among men in the U.S.

Understanding and integrating genomic test results can help healthcare providers and patients create personalized treatment plans, improving the overall care for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genomics to personalize care of prostate cancer. Connors, LM.[2021]

The National Comprehensive Cancer Network now recommends BRCA1/2 genetic testing for men with metastatic prostate cancer, highlighting its importance in guiding treatment decisions.

Genetic testing can identify not only BRCA1/2 mutations but also other significant genes like CHEK2 and HOXB13, which can impact systemic treatment options and inform at-risk family members about their genetic risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metastatic Prostate Cancer: Effects of Genetic Testing on Care. Connors, LM.[2020]

Current guidelines for molecular diagnostic testing in metastatic prostate cancer highlight the importance of identifying HRR gene alterations, which can help tailor personalized treatment strategies for patients.

Implementing a multidisciplinary approach to molecular testing can improve access to personalized treatments and potentially enhance treatment outcomes for patients with metastatic castration-resistant prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical Guidance on Establishing a Molecular Testing Pathway for Alterations in Homologous Recombination Repair Genes in Clinical Practice for Patients with Metastatic Prostate Cancer. Schostak, M., Bradbury, A., Briganti, A., et al.[2023]

In a study involving 501 patients with advanced prostate cancer, 10.2% were found to have pathogenic genetic variants, leading to discussions about changes in treatment for nearly 46% of those who tested positive.

The model of oncologist-initiated genetic testing, combined with genetic counseling, was found to be feasible and effective, with high participant satisfaction and a median turnaround time of 20 days for results, indicating its potential to enhance clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Impact of a Rapid Genetic Testing Model for Advanced Prostate Cancer Patients. Breen, KE., Symecko, H., Spielman, K., et al.[2023]

The individualized genomic classifier (GC) test significantly influenced treatment decisions for 30.8% of high-risk prostate cancer patients after radical prostatectomy, with over 60% being re-classified as low risk based on the test results.

The use of the GC test reduced decisional conflict among urologists, indicating that it enhances their confidence in making treatment recommendations, particularly guiding the use of adjuvant radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of a genomic classifier on post-operative treatment decisions in high-risk prostate cancer patients: results from the PRO-ACT study. Michalopoulos, SN., Kella, N., Payne, R., et al.[2022]

Only 16.5% of prostate cancer specialists frequently use genetic testing for decision-making, with urologists (26%) using it significantly more than radiation oncologists (4%).

Urologists also perceive genetic tests as more important and express greater confidence in their use compared to radiation oncologists, indicating a potential gap in the adoption of genetic testing in prostate cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician attitudes about genetic testing for localized prostate cancer: A national survey of radiation oncologists and urologists. Kim, SP., Meropol, NJ., Gross, CP., et al.[2019]

This study is a randomized controlled trial involving 346 participants with prostate cancer, comparing an interactive web-based tool for pre-test genetic education to traditional genetic counseling, aiming to improve informed decision-making for germline testing.

The primary goal is to assess whether the web-based tool can effectively reduce decisional conflict and enhance genetic knowledge, satisfaction, and understanding of results, potentially offering a scalable alternative to traditional counseling methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Loeb, S., Cheng, HH., Leader, A., et al.[2022]

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Germline testing for prostate cancer - PubMed Central - NIH

Germline testing (GT) for prostate cancer (PCA) is now central to PCA care and hereditary cancer assessment, with a rising role in PCA screening approaches.

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Prostate Cancer Genetic Testing Lagging Despite Benefits

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Findings from a 20-year study suggest that genomic testing can predict long-term outcomes of prostate cancer.