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Christopher Wallis: Hello, and thank you for joining us for this UroToday Journal Club. Today, we are discussing a recent publication entitled "Pretest Genetic Education Video Versus Genetic Counseling for Men Considering Prostate Cancer Germline Testing: A Patient-Choice Study to Address Urgent Practice Needs". I'm Chris Wallis, an Assistant Professor in the Division of Urology at the University of Toronto. With me today is Zach Klaassen, an Assistant Professor in the Division of Urology at the Medical College of Georgia.

This is the citation for this recent publication in JCO Precision Oncology.

Germline testing in prostate cancer is increasingly important. We have in the last few years recognized a frequency at which germline variants occur in patients with prostate cancer, and in this study from Nicolosi and colleagues, which spans the entirety of the prostate cancer spectrum, nearly one in five or 17.2% of patients had positive germline mutations, including relatively frequent alterations in BRCA one and two, in HOXB13, and in other DNA mismatch repair variants as well.

So this information is increasingly actionable. We now have targeted therapies for which biomarker testing is required for eligibility, namely PARP inhibitors and pembrolizumab. Additionally, germline testing may inform screening strategies for patients with known alterations who have not yet been diagnosed with cancer and inform cascade testing for families. Notably, as I alluded to before, the eligibility for PARP inhibitors depends on the identification of pathogenic variants in a number of DNA repair genes.

As a result of this increased clinical utility, germline testing is increasingly recommended. And so these recommendations come from the NCCN guidelines and suggest that germline testing should be undertaken for all men with metastatic prostate cancer, for those with high-risk localized disease, for all with intraductal or cribriform histology, those who have Ashkenazi Jewish ancestry, as well as those who have a concerning family history, including suggestive of hereditary cancer syndromes. And these increasing indications for genetic testing have increased the demand for genetic counselors and services. The standard approach to germline testing has been to utilize pre-test counseling with genetic counselors in order to help patients understand the nature of cancer inheritance, the purpose of testing, the risks and benefits, the testing panel options, the types of potential results, and the potential implications for both themselves and their families. However, given this relatively intensive process, there are insufficient genetic counselors to meet the demand of an increasingly wide indication for genetic testing in prostate cancer.

There are therefore some alternatives. And so a number of groups have published an approach based on the oncologist or urologist-driven testing, where these clinicians perform the initial pre-test counseling, and only those with positive results on testing get referred for genetic counseling. Other alternatives include telephone or video-based genetic counseling.

In the EMPOWER study, the Evaluation Management for Prostate Oncology, Wellness, and Risk, these authors performed a patient choice study to compare video-based genetic education to genetic counseling among men with prostate cancer. And the goal was to determine key patient-reported outcomes to help streamline the delivery of genetics and genetic counseling care. So they enrolled patients with a personal history of prostate cancer or those without prostate cancer who are at increased risk on the basis of family history. And the men were offered and selected either a video-based education or a session with a genetic counselor.

The authors then assessed each included man with three questionnaires.  The first was a baseline before they selected their choice for pretest information. The second was post-education, that's following their video or genetic counseling session. And the last was following the disclosure of their genetic testing results for those who proceeded with testing. Those who chose genetic testing underwent multi-gene panel testing of 51 genes using an Invitae assay. In terms of the education video, this was developed by the Jefferson Cancer Genetics team and addressed many of the issues that are typically covered in genetic counseling sessions, including the nature of cancer inheritance, the purpose of testing, risks and benefits, the multi-gene panel options and potential results, the implications of results, including treatment for screening, and for cancer management, as well as the implications for hereditary cancer risk for relatives. Additionally, the video addressed questions related to genetic discrimination and possible reproductive implications. Men who opted for the video approach had the option to ask questions of the study coordinator to clarify any issues that arose before they proceeded with the genetic testing.

So in terms of survey measures, this baseline survey captured demographics, the reason for choosing one approach versus the other, their family history, baseline knowledge of cancer genetics, and assessments of health literacy, numeracy, and anxiety. The second assessed the knowledge of cancer genetics to assess for a change in information as a result of their counseling session, as well as their decisional conflict regarding undergoing testing, and genetic counseling satisfaction. Finally, following disclosure, they assessed, again, counseling satisfaction as well as the intention to share the results with their primary care provider and their families. The authors undertook descriptive analysis and used standard tests to compare the video and genetic counseling groups, and they used the t-test to assess for differences in the total score for knowledge of cancer genetics, decision conflict, and for the satisfaction of the post-education session between the two groups.

At this point in time, I am now going to hand it over to Zach to walk us through the results.

Zachary Klaassen: Thanks, Chris. So I've broken down the baseline characteristics into two slides given the size of the table. And you can see here that between the genetic counseling group and the educational video group, there was no difference in these demographics, which we will highlight briefly.

So the age, the mean age, for both groups was roughly 65 years. The majority of these patients were Caucasian at 86%.  In terms of educational background, about two-thirds of these patients had a bachelor's degree or higher, about three-quarters of the patients were married, and about 83% to 90% of these patients had a family history of cancer. In terms of prostate cancer-specific characteristics, 83% in the genetic counseling group and 93% in the educational video group had a history of prostate cancer, with the majority of these being a Gleason score of seven.  Looking at the stage of note metastatic disease, 4.2% of those undergoing genetic counseling had metastatic disease compared to 19.5 for the educational video.

Looking at part two of the baseline characteristics in terms of medical literacy, a majority of patients described themselves as medically literate, at 67% in the genetic counseling group and 74% in the educational video group. In terms of understanding and filling out medical forms, the majority of patients felt comfortable with this, 81% in the genetic counseling group and 84% in the educational video group. In terms of numeracy, about 50% said they were moderately numerically literate. And in terms of anxiety, the majority of these patients did not report anxiety, 62% in the counseling group and 75.3% in the educational video group.

This looks at the summary of reasons for preference for choosing either the pre-test video versus the genetic counselor in terms of genetic counseling.  In terms of why you would like to learn by genetic testing from a counselor, the most common reason was, at 62%, that the patients wanted to be able to ask questions to their provider. And in terms of the educational video, in terms of why the patients chose this, the most common answers were the convenience factor at 62.2%, and at 37.8%, less time commitment.

These are the results looking at the immediate post genetic education survey. In line one you can see, in terms of change of cancer genetics knowledge was favoring genetic counseling versus educational video, but you can see with the plus 1.8 and the plus 0.9, both groups felt like they increased their genetic knowledge after the appointment.

In terms of the genetic conflict score, no difference between these two groups, and in terms of satisfaction at 26.6, very high satisfaction for both the genetic counseling group and the educational video group. This looks at the actual genetic test results, no difference between the genetic counseling group and the educational video group. In terms of a negative result, roughly 50% for both groups. In terms of a variant of unknown significance, 38.2% for the counseling group and 41% for the educational group. In terms of a pathogenic or likely pathogenic mutation, roughly 10% for both groups.

In terms of the intention to share results and satisfaction after the genetic disclosure, the majority of patients said that they would discuss their results with their primary care provider, 72.7 in the genetic counseling group and 62.5% in the video group. In terms of whether they would discuss their results with the family, this was actually significantly favoring the educational video group. But as you can see here, both groups had a high likelihood at 86.4% for the genetic counseling group and 96.4% for the educational video group. Finally, in terms of, did you find the genetic test helpful in your overall health plan? The majority of patients did find this helpful at 86.4% in the genetic counseling group and 80.4% in the educational video group.

So several important discussion points from this study from the Jefferson Cancer Group, as we've seen here with the rise of precision medicine and multiple genes involved in prostate cancer hereditary risk, there is a need to address the shortage of genetic counselors that are available. This is primarily secondary to the expansion of germline testing guidelines, as well as recent FDA approval of PARP inhibitors. There are thousands of men that are eligible for germline testing, and they need the information to make informed decisions for this type of testing. And additionally, with millions of prostate cancer survivors now eligible for testing to assess the risk of cancer in their families, this shortage is becoming more paramount. Indeed, the rising need for germline testing has led to a strain on the health care system leading to long wait times for genetic counselors, which certainly hinders the rapid return of test results and subsequent therapy.

Because of this, urologists and oncologists are ordering germline testing themselves, and they are in need of tools for men to provide pre-test information in order to make informed decisions. What we found in the EMPOWER study today is that the majority of men did choose a pre-test video over a genetic counselor. And this was listed because of the convenience, the less time commitment, and no wait times for genetic counselor appointments. This study showed that there was no difference noted in key patient-reported outcomes for making a decision for genetic testing, and more men who did the pre-test video intended to share their results with their families. In terms of implementing a pre-test video into clinical practice, especially in the clinic, there is a need for time to view the video, space to view this privately, and it is important for the availability of experts in genetics to answer questions from the patients. If these videos are viewed outside of the clinical appointment, it's important for practices to have follow-up appointments to address these questions as well as to coordinate genetic testing.

So in conclusion, a substantial proportion of men opted for pre-test video-based genetic education with comparable patient-reported outcomes and uptake of germline testing. These results support the use of pre-test genetic educational videos in non-genetic practices in order to address the shortage of counselors and to advance germline testing, to capitalize on the progress of precision medicine, particularly as it relates to prostate cancer, and certainly, further research in diverse populations and across various practice settings is warranted for this.

Thank you very much. We hope you enjoyed this UroToday Journal Club discussion.