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

Trial Summary

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 data supports the effectiveness of the Tumor Genomic Pre-test Counseling Tool for prostate cancer treatment?

Research shows that genomic testing can help doctors and patients make better treatment decisions for prostate cancer by predicting the risk of cancer spreading and identifying personalized treatment options. This approach is supported by guidelines that encourage shared decision-making between healthcare professionals and patients. ^{1 2 3 4 5}

How is the genetic counseling tool for prostate cancer different from other treatments?

This treatment is unique because it focuses on personalized genetic counseling for prostate cancer, using multigene panel testing to tailor cancer screening and therapy. Unlike traditional treatments, it emphasizes genetic evaluation to inform precision therapy and involves novel methods for delivering pre-test education, addressing the shortage of genetic counselors. ^{4 6 7 8 9}

What is the purpose of this trial?

The overall goal of the study is to improve equitable delivery of pre-Tumor genetic testing (TGT) counseling tool for Black or African American men with metastatic prostate cancer and evaluating the tool for implementation.

Research Team

Daniel Kwon, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. England 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. [2022]

2. Netherlands 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Physician attitudes about genetic testing for localized prostate cancer: A national survey of radiation oncologists and urologists. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Inherited Mutations in Men Undergoing Multigene Panel Testing for Prostate Cancer: Emerging Implications for Personalized Prostate Cancer Genetic Evaluation. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical Impact of a Rapid Genetic Testing Model for Advanced Prostate Cancer Patients. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. Spain pubmed.ncbi.nlm.nih.gov

Genetic counseling in prostate cancer: How to implement it in daily clinical practice? [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Genomics to personalize care of prostate cancer. [2021]

9. United States 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. [2022]