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Conversations With Prostate Cancer Experts


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Prostate Cancer Diagnosis + Risk Stratification

Dr. Leonard Gomella spoke at the 18th Future Directions in Urology Symposium in Colorado Springs in August 2017. In this video interview, he offers a short summary of the talks he gave at that conference.

He focuses on two factors for prostate cancer diagnosis and risk stratification that he is researching and interested in improving. The first factor is the role of genetic testing for prostate cancer risk. He reviewed our preliminary consensus data from a big meeting in Philadelphia back in March to talk about what are the indications to sending a patient on to genetic counseling for further potential screening for inherited prostate cancer risk. He talked about things that will be coming out in his paper at the end of the year.

The second topic he addressed is what he calls Beyond MRI. He spoke about the new evolving next generation imaging involving PET scanning. He talked about the fact that there are 20-30 different PET scan technologies out there, but in reality only about 5-6 are getting attention right now. He believes that these new PET imaging will allow us to move beyond standard MRI and standard CAT scans and get much more information about disease status in individual patients.

 


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How Has Imaging Impacted Treatment?

Shore_001Dr. Neal Shore comments on this month’s discussion of the ways imaging has impacted prostate cancer treatment.

Imaging is important for newly diagnosed prostate cancer patients who may or may not have localized disease, and it’s especially important for advanced prostate cancer patients, whether they continue to be androgen sensitive or have developed some level of androgen resistance. For earlier stages of disease, there has been a lot of interest regarding multiparametric MRI. Nonetheless, the efficacy of multiparametric MRI is limited by the expertise of the interpreting radiologist. The fusion technology software championed by several of the academic centers has been rolled out without consistency within the community. For some practices, it was adopted due to marketplace competition and the device developers’ promotions. Companies that develop multiparametric fusion technology have not made a significant contribution to the advancement of urologic and radiologic educational needs. That said, some groups incorporated dedicated specialists within their practice to train for high-quality multiparametric fusion-based biopsies. Purchasing the newest promising technology without ensuring a framework to optimize clinical results will lead to poor implementation. In the United States, MRI is still mostly recommended for patients who have had a negative prostate biopsy, but due to age, PSA kinetics, or rectal examination, there is still a concern of possible malignant disease that was missed on the first biopsy. MRI is most uniformly accepted for additional information when evaluating patients for the need for a second biopsy. MRI will no doubt have an ongoing role in the active surveillance population. MRI will no doubt have an eventual role in decision making for possible first biopsies.

 

There has been a lot of very good, evidence-based literature coming from European countries that suggests that whole-body MRI, with the right software protocol, is exceptionally helpful in evaluating metastatic disease. Unfortunately, in the United States, this protocol takes 45 to 60 minutes to accomplish, and unfortunately, translates to a challenging economic utility model for the MRI efficiency from an administrator perspective. There are many interesting and promising blood-, tissue, and urine-based markers, genomic assays, and additional imaging techniques, which require ongoing trials to determine how best to use them for the most efficient value-based care model. No single test—MRI or any other blood-, tissue-, or urine-based marker—is perfect. Eventually, we will hopefully develop a cost-effective algorithm that combines a panel of all the different biomarkers. MRI is part of that discussion, but we don’t have that sorted out currently. There have been multiple PET scan technologies developed in the last several years that have been assessed for improved potential sensitivity and specificity, and ultimately, to improve the accuracy of the data that shows cancer spread and its location. MRI and Axumin PET scanshave been approved for advanced prostate cancer patients. There have been other PET scans such as FDG, C-11 Acetate, C-11 Choline, sodium fluoride, which have not received widespread reimbursement approvals nor widespread accessibility. There is also no consensus recommendation for these technologies.


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Advances in Medical Oncology

PetrylakDr. Daniel P. Petrylak, Professor of Medicine and Urology at Yale School of Medicine, has been a pioneer in the research and development of new drugs and treatments to fight prostate, bladder, kidney, and testicular cancers.

Prostatepedia spoke with him about advances in medical oncology for prostate cancer.

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What are the current points of controversy and/or trends in the field of medical oncology for prostate cancer?

The first controversy is over localized disease. There are really two forms of prostate cancer. There is the nonaggressive form that is not going to be lethal and that you’ll die with and not from. Then, unfortunately, there is the lethal form of the disease that kills about 30,000 men a year in the United States. The controversy is how do you treat these patients? How do you decide who to treat and who not to treat?

For advanced metastatic disease, there are controversies over the right treatments, the right sequences of treatments, when to use other hormones, and when to use other chemotherapies. There are a lot of questions that need to be answered.

Unfortunately, prostate cancer has always been behind other tumors. If you look back to the 1990s, there was about five times less funding for prostate cancer than breast cancer. We were behind in funding compared to other tumors, but have made significant strides in increasing money available for research.

We’re catching up in the area of personalized medicine. We didn’t really have markers a couple of years ago. But now we’re beginning to see markers—whether that be with BRCA mutations, BRCA-like mutations, or AR-V7—employed in the treatment of advanced metastatic disease to help select therapies. These approaches are in the advanced stages of development and have yet to be approved by the FDA. Those are the major controversies.

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A New Prostate Cancer Vaccine?

Dr. Charles G. Drake of New York-Presbyterian/ Columbia University Medical Center spoke with Prostatepedia about new prostate cancer vaccines under investigation.

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Dr. Charles Drake: Hopefully before the end of the year, a trial called PROSPECT will read out. (Though it’s hard to tell nowadays when trials are going to read out because we already have a reasonable number of options: six FDA-approved drugs for men with metastatic castration-resistant disease.) PROSPECT is an international randomized Phase III trial of about 1,200 men that looks at Prostvac, an off-the-shelf PSA-targeted vaccine. The trial’s primary endpoint is overall survival.

Unlike the Provenge (sipuleucel-T) trials, which were sometimes a little complicated to interpret because we had crossover, patients on PROSPECT didn’t crossover. That means that patients on the placebo arm who progressed were not eligible for Prostvac, instead, they went on to standard treatments. The lack of crossover means we expect a fairly clean set of survival data to come out from this large PROSPECT trial. There are a lot of folks in the prostate cancer community looking forward to seeing whether or not PROSPECT will have a survival benefit.

So then we’d have two vaccines for prostate cancer?

Dr. Drake: Provenge (sipuleucel-T) is an active drug with clear utility. The challenge with Provenge (sipuleucel-T) is that patients need to undergo leukapheresis to prepare this personalized vaccine. Prostvac is more like the vaccinia vaccine that was used for smallpox. It will be a bit easier to distribute widely.

Is inconvenience the only factor limiting Provenge (sipuleucel-T) use?

Dr. Drake: The prostate cancer field is like all other fields in that we tend to be trendy at times. When Provenge (sipuleucel-T) was first approved, there was a ton of enthusiasm about it and lots of people were using it. In fact, there was a bit of controversy over whether or not we could make enough of it.

With all the new drugs coming out, Provenge (sipuleucel-T) is probably used less than it once was. But this is something that has been FDA approved and has a clear survival benefit.

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Changing PCa Screening Recommendations

Ms. Merel Grey Nissenberg, a California attorney specializing in medical malpractice cases, is the President of both the American- based National Alliance of State Prostate Cancer Coalitions (NASPCC) and the California Prostate Cancer Coalition (CPCC).

Prostatepedia spoke with her about the recent proposed changes to the US Preventive Services Task Force (USPSTF) recommendations on screening.

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How did you become involved in prostate cancer advocacy?

IMG_3119Ms. Merel Grey Nissenberg: I’m a trial attorney. I handle medical malpractice cases.

Obviously, I don’t have a prostate. I don’t have anybody in my family who passed away from prostate cancer, but I’m very interested in prostate cancer and in cancer advocacy.

In my law practice, I’ve handled a lot of prostate cancer cases with inexcusably late diagnoses. Just shabby care. A lot of those clients have passed away because of that.

In 1994, I handled a case that had a surgical oncologist as one of our experts. He recommended that I start working on the California Division of the American Cancer Society’s Prostate Cancer Task Force, which I did.

I then went on to co-chair the task force. In 1997, there was a California-wide American Cancer Society meeting on prostate cancer. We thought it would be great to have a statewide California coalition for prostate cancer. Everybody said we couldn’t do it because California is too big. We heard that challenge. The California Prostate Cancer Coalition is now 20 years old!

Was this the first American statewide prostate cancer coalition?

Ms. Nissenberg: At that time, Pennsylvania had a coalition and Massachusetts had a fledgling coalition. A few other states were just starting coalitions.

In 2001, I went to a meeting with 20 state leaders in Washington, DC, at the former National Prostate Cancer Coalition (NPCC.) NPCC is now ZERO. We wanted to see how the states could help their organization—and how NPCC could help the states with their missions.

At that meeting, I met a lot of people from other state coalitions. I said I’d like to set up coalitions in all 50 states. Jan Marfyak, a prostate cancer survivor who was co-chair of the Pennsylvania coalition at the time, thought that was a great idea. Together, we started raising money to set up state coalitions.

In 2004, we decided to set up a national alliance, an umbrella organization, which would allow states to network with each other and to share best practices. This is now the thirteenth year of the National Alliance of State Prostate Cancer Coalitions.

Our original goal was to make prostate cancer a national healthcare priority by becoming a collaborative force that developed and mentored state prostate cancer coalitions.

In 2014, we added two core priorities: awareness and education, and public policy advocacy. To address awareness and education, we created a guide on prostate cancer screening aimed at patients and primary care physicians alike.

How have the United States government’s recommendations on prostate cancer screening changed?

Ms. Nissenberg: When I first got involved with prostate cancer advocacy, the recommendation was inconclusive whether you should screen or not. In fact, in our work, we use the word “testing” because the term “screening” is so controversial.

In 2012, which was the most recent USPSTF Recommendation, the US Preventive Services Task Force announced a straight across-the-board D recommendation: do not screen. Most physicians saw the “D” at the top of the page and never read beyond that.

But then we went back and looked. In the middle of the middle sections of the recommendations, in the Clinical Consideration section and in the Reply to Public Comments section, the Task Force clearly says that if a man wants to have an informed discussion about prostate cancer, his physician must—this is mandatory language—have that discussion with him. It is then the patient’s decision based on his own values and preferences whether or not to get tested. It was buried in the guidelines, but it’s there.

I know a lot of men have since gone for their regular physicals and have not been offered PSA testing, even though they’re getting blood drawn for other things. The issue of prostate cancer screening is not brought up. They’re not even offered digital rectal exams (DRE).

There was a huge outcry after the 2012 Guidelines became final; they did not take into account your family history, if you’re African-American,
 or if you have been exposed to Agent Orange or any other type of banned chemicals. (Agent Orange is a huge risk factor for Vietnam veterans.)

The 2012 recommendation scared men away from asking for testing. Later the California Prostate Cancer Coalition and the American Cancer Society worked together briefly to get some language into the ACS guidelines that we could both live with. We did not like the way ACS used the phrase potential benefits and harms instead of potential benefits and potential harms. (The word “potential” only referred to the benefits, not the harms.) It made the benefits only potential, but the harms certain.

Precision in language is important…

Ms. Nissenberg: Exactly. But the USPSTF proposed changes to the guidelines in April of this year; it would still be a D recommendation for men 70 and over (with no regard to life expectancy), but a C for men 55 to 69. They’re recommending that a man speak with his physician and that the physician offer the man an informed discussion about prostate cancer testing.

Based on the 2012 guidelines, physicians didn’t have to bring up testing at all. They were completely relieved of the responsibility of bringing up prostate cancer testing. Physicians felt that legally they didn’t have to discuss testing with men.

An informed discussion is not the physician telling you why you don’t want to be tested. Your physician is supposed to discuss the risks of being diagnosed with a cancer that doesn’t need treatment. He or she should also discuss the benefits:
 if you have an aggressive disease, early detection is critical.

Men need to know that this is their decision to make, based on their preferences and values. It’s not for someone else to say that you don’t need to know about this.

I’ve dealt with cases in my law practice in which the doctors actually note in medical records that the patient wants a PSA. “Patient is worried about prostate cancer.” And still some doctors have refused to test. Some of those patients are dead now. People tend to trust whatever the physician says.

It’s that old hierarchal relationship people have had with their doctors.

Ms. Nissenberg: Right. They just tend to think he or she has this superior experience, training, and expertise, so if the physician says don’t worry, the patients won’t worry.

But, as I said, physicians haven’t even been bringing testing up and have felt legally justified in not doing so.

The way I see it is that you have 
to educate, not just the primary care doctors, but also men—prospective patients—so they know to ask about prostate cancer screening. You can’t ask for an informed discussion about something you don’t know exists. We need to educate both groups.

So from the D recommendation of 2012, the proposed guidelines now say that physicians should discuss the potential benefits and risks associated with screening with men 55 to 69.

But the NASPCC and the CPCC 
have problems with the new proposed guidelines. First, why start at age 55? We advocate that a man get 
a baseline PSA in his early 40s.
 This gives a risk assessment;
 you can then personalize follow-up.

If you’re at low risk based on your PSA reading, you don’t have to come back for retesting for another five years. (No one is suggesting that men get yearly PSA tests.)

If you’re at intermediate risk, you get retested every one to two years, depending on your other risk factors.

Men at high risk would obviously need immediate follow-up.

Even the Task Force itself acknowledges in the Frequently Asked Questions section of the new proposed draft guidelines that sometimes you don’t see a benefit to screening for over 10 years. Sometimes 10-
15 years. If you wait to get baseline tests until men are 55, you lose an opportunity to prevent some of them from developing metastatic disease.

Another change in the recommendations is that the Task Force now discusses active surveillance. The guidelines say that there are men who will choose active surveillance, so those men will not be overtreated by definition. But the guidelines did not also acknowledge the fact that we now have urine, blood, and tissue markers that can help determine whether or not a man is at risk for aggressive disease. Why worry about overtreatment if a man is diagnosed, but not acknowledge the availability of biomarkers to select those at high risk for clinically significant prostate cancer?

Lastly, NASPCC and CPCC believe that Vietnam veterans and others exposed to Agent Orange should be included in the Task Force definition of a high-risk group (that currently includes African-American men and men with a family history of prostate cancer).

We do applaud that the Task Force is now finally openly talking about informed decision-making.

It’s important to remember that not everyone who is tested will be overtreated. (I don’t believe there as such a thing as overdiagnosis.) Diagnosis is just information.

You can choose not to be treated once you have the information.

Ms. Nissenberg: Exactly. You wouldn’t tell a woman, “You don’t really want to know if you have breast cancer, dear.”

After a certain age, women get mammograms yearly.

Ms. Nissenberg: Exactly. Physicians take that choice away from men.

We distribute our decision-making guide to physicians as well as patients so that they know which questions the patient is going to ask. (Men aren’t going to be coming in with 500 pieces of paper from the Internet.)

In the guide, we talk about things
 like baseline PSA, the importance of family history, ethnicity, and exposure to Agent Orange. Questions like: If I have a biopsy and it reveals cancer do I necessarily have to have treatment? What is active surveillance?

Good, basic questions and answers.

Why are they revising the guidelines now? Because of the outcry in the prostate cancer community? Or is this just part of the normal cycle of revision?

Ms. Nissenberg: It is part of the normal cycle of revision. The outcry probably helped precipitate it, but this is just their normal timeframe.

What do you feel are the greater implications of the guideline changes?

Ms. Nissenberg: The implications are that more men will hopefully be tested. More men will have that conversation and make their own informed decision about whether they want to be tested or not.

The changes to the guidelines will raise awareness at the very least.

The changes are a good start, but we’ve got to go further.

Read June 2017 Prostatepedia for more information on screening.


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To Biopsy or Not To Biopsy?

David Crawford is the distinguished Professor of Surgery, Urology, and Radiation Oncology, and head of the Section of Urologic Oncology at the University of Colorado Anschutz Medical Campus as well as the driving force behind PCMarkers.

Prostatepedia spoke with him about how practitioners can fine-tune prostate cancer screening.

Crawford copy

Why did you become a doctor?

Dr. E. David Crawford: I got my interest in medicine from my family. They had
a nursing home. I worked there when I was in high school and college, so I was around patients and doctors. I saw the compassion the doctors had and really liked it. I got to know a few of them.

Even though that was only a snapshot, I thought medicine would be a good thing to do. Then I got a job during college doing evaluations of people before surgery. That was how I got interested in urology.

My interest in prostate cancer began when I was at the University of California, Los Angeles, as a Fellow. I was dumbfounded that most of the patients we saw with prostate cancer were advanced and incurable.

I had an opportunity to work with Schering Corp. I did a study and got one of their drugs called Eulexin (flutamide) approved.

A man named Perry Lieber from
Las Vegas came to see me. The only way he could get Eulexin (flutamide) was on my Phase III trial. He was
a spokesman for Howard Hughes. He wanted to get the word out about early detection for prostate cancer. We started some of the early screening back in the 1980s in Las Vegas and
in Colorado. Unfortunately, he died
of prostate cancer.

This was in 1988. We didn’t know what we were doing. We had PSA; we were testing and biopsying a lot of people. At first, that was good because we found a lot of aggressive prostate cancers.

Once we filtered through those, though, we were biopsying people at lower and lower PSAs and finding prostate cancers that didn’t need
to be found. There was a lot of overdiagnosis and overtreatment.

That went on for a while. Then the US Preventive Services Task Force said they think screening does work, but that it does more harm than good, so they couldn’t recommend it. (They have more recently changed their recommendations.)

That put the brakes on things, but I think it was needed. When we do too many biopsies and rebiopsies and overtreat people, we have no way to restratify them.

I think the way forward is pretty simple. It involves prostate cancer markers: blood, urine, and tissue-based markers.

But first consider who orders PSA tests in the United States: family practice doctors order 92% of PSA tests. We have to educate these family practice doctors.

I did a study a few years ago that looked at the PSA cutoff of 1.5 ng/ ml. What if you find prostate cancer in that zone of 1.5 to 4? We found that 70% of men who had their PSA analyzed had a level of less than 1.5 ng/ml and, therefore, could come back in 5 years for another one.

That’s an easy message: a PSA above 1.5 to 4 ng/ml is a danger zone. Prostate cancer marker tests come into play in men with PSAs in that gray zone of 1.5 to 4 ng/ml.

Everyone is talking about informed decision-making with these tests before a PSA is performed, but this is not going to happen. Family practice doctors have more significant things to talk about with their patients: obesity, hypertension, or diabetes. They don’t get informed decision to check your cholesterol, your blood pressure, or your weight. They get informed decision after the fact.

I think you should do the same thing with PSA. Doctors should order the PSA tests in the right group of people. If the PSA is less than 1.5, no discussion is needed. Tell the man to come back in five years.

If his PSA is greater than 1.5, we need the next layer of testing and discussion. The goal right now is simple.

PSA is a frontline test to help identify people at risk for having prostate cancer. PSA doesn’t tell us what kind of risk. It doesn’t tell us if the man has low- grade or high-grade prostate cancer. That is where some of these new tests come in. PSA screening by itself, without any further testing, is gone. PSA is just the first test.

If a doctor were considering doing a biopsy and worried about prostate cancer, the next step would be genomic testing.

What sorts of genomic testing would be appropriate in this setting?

Dr. Crawford: The tests fall into three buckets: blood-based, urine-based, and tissue-based.

The ones I’m working on now are either blood- or urine-based tests. The prostate health index (PHI) is a formula that looks at several forms of PSA to come up with the relative risk of having prostate cancer. Phi is FDA-approved in the US for use in men with a PSA above 4: it gives their relative risk of having prostate cancer.

There are two issues with PHI. First, in Europe, the PSA cutoff is 2. In the United States, the PSA cutoff is 4. But we still have a lot of prostate cancer in men with a PSA between 1.5 and 4. We published a paper that showed a 10-13% higher risk in men with a PSA between 1.5 and 4.

Second, we need more data on PHI levels and high-grade cancers. We’ve done some studies that show that there seems to be a good correlation between high PHI levels and high-grade cancers.

The other test is 4Kscore, which looks at the four prostate-specific kallikreins in the blood: Total PSA, Free PSA, Intact PSA, and Human Kallikrein 2 (hK2). The company adds their secret sauce and gives your relative risk of having high-grade prostate cancer.

If your 4Kscore is less than 7%, you don’t worry. Above 7%, you do. Still, some people have high-grade cancer when their 4Kscore is below that—you have to account for other risk factors—but it’s another good blood test.
It’s easy to do. The cost is down
to less than $700 now. They’re trying to get Medicare coverage.

Another test is the urine-based test SelectMDx. This test is done after a digital rectal exam. It is based on two genes that are overexpressed
in high-grade prostate cancer. You measure the messenger RNA in urine.

What I like about SelectMDx is that if the test comes back negative, it has a 99% negative predictive value that you don’t have a high-grade cancer like a Gleason grade 8, 9, or 10 and a 98% chance you don’t have a Gleason 7 or above cancer.

If the SelectMDx comes back negative, it makes you feel really good. If it comes back positive, it gives you a relative risk of low-grade and high-grade cancers. The aim is to find the higher- grade cancers.

Right now, I think one of the more promising genomic tests is the SelectMDx.

Why so much of a push to develop these molecular markers?

Dr. Crawford: It’s time. This is the era of personalized medicine. This is a way of addressing the issue of overdiagnosis and overtreatment.

There are approximately 1.4 million prostate biopsies done in the United States every year, but we only diagnose a couple hundred thousand people with prostate cancer. Many get rebiopsied and rebiopsied and rebiopsied.

If your biopsy is positive and you’ve picked up a low-grade cancer, you might then choose a molecular marker
to determine your cancer’s aggressiveness. These are the tissue-based genomic tests, such as Oncotype DX, Prolaris, and Decipher.

Another is called ConfirmMDx.
This is a tissue-based test that
looks for genetic changes called methylation genes around the cancer. (These are areas of cancerization.)

If the biopsy is negative and we order ConfirmMDx on the tissue and that test comes back as positive, it means we’ve widened the target area: we may have missed something and need to go back and look again with another biopsy.

Are prostate cancer markers covered by insurance?

Dr. Crawford: Only PHI and PCA3 have been approved. (PCA3 has pretty much gone by the wayside, though, after the introduction of SelectMDx.)

It happens this way: the company does some clinical trials, they bill insurance, and then they submit to Medicare. They get local coverage determination in which the test will be covered for a period of time while they continue to investigate.

The companies who make these markers are not big companies with deep pockets. They have a limited budget.

If we wait for an endpoint of death on some of these studies, none of us will be around to see the results. We need to think about other endpoints. We are looking at these other endpoints.

I’m excited about all this. I think we’ve got a way forward now. Most family practitioners believe
that screening does do some good, but they know that it also does some harm. Now that we’ve got the tools to deal with screening, let’s deal with it. Patients believe in screening. We don’t want to go back to where we were with metastatic disease being the norm.

Do you think the former recommendation against screening ended up having
a positive impact? That it forced the prostate cancer community to reevaluate the issue of overtreatment?

Dr. Crawford: A lot of people don’t think that, but I do. There was a lot of overdiagnosis and overtreatment.

Sometimes when you tell a man
he has cancer, he wants it taken care of yesterday. Many don’t understand that some prostate cancers are like skin cancers. You don’t cut off your arm because you have a small basal cell cancer on your wrist. It’s the same way with prostate cancer. There are low-grade, nonthreatening Gleason 6 cancers.

Are these prostate cancer markers now widely accepted among family practitioners?

Dr. Crawford: No. Family practice doctors don’t know much about these markers at all. Urologists don’t either. This is the beginning of a long educational process. It’ll take patients asking about the tests. Often, patients drive change: that’s just the way things happen.

Many of our readers are influential in their communities. What would you say to those men about getting the word out about prostate cancer markers?

Dr. Crawford: There are a lot of hereditary and germline mutations being put forth in prostate cancer:
as many as 5% up to 20% of prostate cancer patients will have some of these mutations.

One of my recommendations
is that if you have germline mutations of prostate cancer like BRCA2 (and others) your family members should get tested.

The PSA cutoff of 1.5 falls in very nicely with this. If your PSA is 1.5 or above, get the tests we discussed— like the SelectMDx or the 4K.

What about repeating these tests? If a man consistently has a high PSA, would it make sense to keep repeating these tests?

Dr. Crawford: He should be referred to a urologist.

Are these tests at all useful in men on active surveillance or with low-grade cancers?

Dr. Crawford: Thirty percent of patients fail active surveillance. When these men eventually have surgery, sometimes they have adverse pathology. Why did that happen? It happened because when we did the biopsy, we missed the bad cancer—the Gleason 7s, 8s, 9s, and 10s. Some of these tissue markers, like Prolaris and Oncotype DX, can help in that scenario.

Part of the follow-up for men on active surveillance is a repeat biopsy. I haven’t met a lot of men who like to have biopsies every year, but they do it.

After a while, doing repeat biopsies and monitoring gets to be more expensive than treatment. A urine test like SelectMDx or 4K can help you determine who needs to be rebiopsied.

What I’m looking at now is whether or not doing the SelectMDx every other year can eliminate the need for biopsies. And I’m finding the answer is yes.