Friendly Reminder: Replace the Random Biopsies!

For decades the random 12-core biopsy has been the standard of care for diagnosing prostate cancer. What most men don’t know is that random biopsy can be dangerous and its results misleading. Fortunately, there are now better ways to interpret a high PSA that are less invasive, safer, and more accurate. The tragedy is many men don’t know this. One million men continue to get random biopsies each year despite having better options.

This episode discusses the dangers of random biopsy and the best steps to take when facing an elevated PSA. If you’ve already been diagnosed with prostate cancer, share this episode with your friends and family! There are better, safer ways to interpret high PSA.

Dr. Scholz:  [00:03] We’re guiding you to treatment success and avoiding prostate cancer pitfalls.  I’m your host, Dr. Mark Scholz.

Liz:  [00:09] And I’m your cohost, Liz Graves.

Dr. Scholz:  [00:13] Welcome to the PROSTATE PROS podcast.

Liz:  [00:16] A lot of our listeners are men who already have prostate cancer.  This episode is for those people’s friends who have a high PSA and are wondering what to do.  Do they get a random biopsy?  Is that dangerous?  Are there any alternatives? 

Dr. Scholz:  [00:32] Yeah, Liz, I come across this all the time after I have a face-to-face meeting with one of our patients and we’re helping them with their prostate cancer.  They mention “Oh, by the way, my friend Sam called me up and his PSA is running high, and his urologist wants to do a 12-core biopsy.  Can I run his case by you, Dr. Scholz?”  

Liz:  [00:52] This episode, Dr. Scholz and I are going to talk through some easy points that you can share with men going through this, and we’ll also post a flow chart on our blog, prostateoncology.com/blog.

Dr. Scholz:  [01:06] One thing that really motivates us is the concern that too many men are getting random 12-core biopsies.  We’ve talked before about the wonderful advances in imaging for prostate imaging that have been developed over the last few years.  If 12-core biopsies were harmless, they certainly provide accurate, useful information, but they can cause complications.  Imaging is actually more accurate.  Unfortunately, the industry is sort of stuck in the past and 12-core biopsies are still being done with great frequency.  Hopefully we can give you some idea of when this may or may not be indicated. 

Liz:  [01:47] Yeah, this is one of those things in prostate cancer, where there are better options, but men are really just hearing about random biopsy.  It’s the option most people get.  Almost everyone knows someone who has had a random biopsy.  There are about a million of these done each year, so it’s kind of public knowledge that when you get a PSA, you’ll likely get a random biopsy. 

Dr. Scholz:  [02:10] It’s been this way for historical reasons.  The random biopsy was a big breakthrough in 1987.  It was approved the same year PSA came on the market.  So when the PSA was high, everyone would get a 12-core, round-the-clock, needle sticking in their prostate.  Really there was no other alternative because imaging for so many years, really wasn’t adequate to see prostate cancer inside the prostate. 

Liz:  [02:38] When you’re comparing this to a different type of cancer, let’s say liver cancer, they’re not just taking random samples of the liver.   Are they expecting that there’ll be imaging?  And why is the prostate something that’s handled so differently? 

Dr. Scholz:  [02:54] I think it’s because historically the cancers that come from the prostate, aren’t very malignant, thank God, and they tend to have a similar background appearance to the prostate gland itself.  So, very specialized techniques had to be developed for the cancers to light up to an adequate degree, to be visible on these scans. 

Liz:  [03:15] Before we get into imaging, let’s address some of the risks of random biopsy.  The first risk is something that I know you’re very passionate about and actually wrote The Invasion of the Prostate Snatchers about, and that’s the over-diagnosis of low-grade cancer.  These are the Gleason 6 cancers. 

Dr. Scholz:  [03:33] We now know that Gleason 6 cancers don’t spread and to call them cancers is an egregious overstatement.  They still do call it cancer however, and this creates confusion.  It’s really better for men if this isn’t diagnosed.  It doesn’t spread and it doesn’t need treatment.  12-core biopsies are much more likely to find Gleason 6 cancers than an image guided biopsy.  This is one excellent reason to avoid a 12-core biopsy. 

Liz:  [04:07] This is something that we’re kind of in an uphill battle against.  You said that Gleason 6 cancer doesn’t need to be diagnosed.  And I think a lot of men think, well, if I have cancer, don’t I want to know about it?

Dr. Scholz:  [04:20] Yeah.  Not only do men think they should know about it, but they think they should be treated for it.  Cancer is an action word.  And the idea of sitting quietly and doing nothing with a cancer seems totally ridiculous.  It’s the problem with the naming of this entity, which really isn’t a cancer, but it’s called a cancer.  The best analogy I’ve ever come up with is the difference between melanoma and squamous cell carcinoma of the skin.  The melanomas are the type of cancers that can spread, and the squamous cells stay put and don’t spread, yet they’re both called cancers. 

Liz:  [04:56] So a biopsy can diagnose men with Gleason 6 prostate cancer, and then they’ll rush into treatment.  They’ll get surgery, they’ll have terrible side effects that will be lifelong.  So it’s really dangerous to be over-diagnosed with a low-grade cancer. 

Dr. Scholz:  [05:11] Yeah, really, if there was no other option, we’d keep quiet about random biopsies.  I saw a patient just yesterday in the office; a sweet eighty-five year old man came to me because his urologist wanted to do another biopsy.  His PSA is running high, around 10, and his 20-core biopsy that was done in 2018 caused him to bleed three and a half units of blood.  How frightening!  If it was necessary to take these risks, one can certainly understand doing another biopsy, but imaging, now we know, is much better. 

Liz:  [05:49] Beyond over-diagnosis, biopsies are dangerous.  There’s a risk of infection, erectile dysfunction, rectal bleeding. The list goes on.  But I think a lot of patients don’t have this conversation with their urologists or if they do, they think it’s just kind of what needs to happen to figure out the cause of their PSA. 

Dr. Scholz:  [06:11] I mentioned a patient who had a bleeding problem, but the real fear is that 1% of the time men develop infections that are so serious that they have to go to the hospital.   For otherwise healthy men to be hospitalized with really life-threatening infections is a tragedy.  When we know we have other approaches that can be just as effective, or even more effective than doing a biopsy. 

Liz:  [06:34] The other thing too, as we talked about in the last episode, PSA can be from multiple different things, including just a big prostate.  So sometimes men with big prostates will have biopsy after biopsy and they’re not finding cancer, but their PSA’s are still high. 

Dr. Scholz:  [06:52] This becomes more common in the men with larger prostates.  So a man with a very small prostate that has multiple needles stuck into his gland is most likely going to get a good, clear sampling.  But doctors know that with big prostates, sometimes they have to do more and more biopsies to get a good chance at finding all the cancers. 

Liz:  [07:13] A 1% infection rate may not seem that big, but considering that one million men get prostate biopsies each year, that means about ten thousand men are going to the hospital with infection. Random biopsies can also miss high-grade cancer.  This happens about 20% of the time. 

Dr. Scholz:  [07:32] So the first step to consider is a blood test called OPKO 4K.  This test is more useful than PSA because it clues the doctors in when there’s a higher grade cancer present, a Gleason 7 or above.  Unfortunately it’s not a perfect test.  It gives a percentage likelihood that a higher grade cancer is lurking in the gland.  This is certainly useful, if the percentage is very low, say less than 5% likely such individuals could consider then skipping doing a biopsy and just continuing on their PSA monitoring. 

Liz:  [08:09] So a lot of our listeners may have experienced random biopsies and obviously they’re uncomfortable.  They’re dangerous, and they’re not necessarily something you’d want to tell your friend to go do.  So what are some options that men with high PSAs have that allow them to avoid the random biopsy, but still get accurate results and understand their PSA? 

Dr. Scholz:  [08:35] Yeah.  This is really the big breakthrough for over the last few years.  The imaging in particular with a multiparametric MRI is truly more accurate than a biopsy and studies have proven this.  Of course MRIs are non-invasive.  If an MRI shows a spot it’s graded from 1 to 5 on a system called the PI-RADS system.  If the spot is graded a PI-RADS 4 or 5, some doctors say level 3, then a targeted biopsy to see what’s in the spot is necessary.  So in certain situations you can’t avoid doing a biopsy, but a targeted biopsy would involve possibly two or three biopsy cores rather than a dozen or more cores. 

Liz:  [09:21] In our office, OPKO 4K is the most used, but there are competitors like SelectMDx and ExoDx, which do kind of the same thing.  So the OPKO 4K report will come back and it will give a percent likelihood that you have a Gleason 7 or higher prostate cancer.  If the likelihood of having one of these consequential cancers is low, patients should go back to annual PSA monitoring.  If the likelihood is high, patients should consider getting scanned with an MRI or a color Doppler ultrasound.  So before we get into targeted biopsies, I wanted to mention that it’s very important about where you’re getting your MRIs done.  These can be tricky things to read and tricky things to perform, so going to a center of excellence will give you the best results. 

Dr. Scholz:  [10:14] Yes, in fact, if patients bring MRI reports to my office for interpretation, and I don’t recognize the place where the MRI was done, I routinely asked for those images on a disc and forward them to a center of excellence like UCLA, Cornell, UCF, and have the images over read by a valid expert. 

Liz:  [10:36] Where does the color Doppler ultrasound fit into this? 

Dr. Scholz:  [10:41] Not very many doctors see enough patients to get skillful with color Doppler ultrasound.  We, however, find it very handy because it’s a simple office procedure and it gives us information as to whether there is a suspicious area on the gland, just as the MRI does.  It also tells us how big the prostate gland is, which allows us to get a sense of why the PSA might be elevated.  For example, if the prostate is particularly large and the PSA is only minimally elevated, it’s quite likely that the high PSA is merely from the big prostate, rather than coming from a cancer.

Liz:  [11:19] Just as it’s important for people to get scanning at centers of excellence, it’s also important to note that targeted biopsies require that same level of expertise. 

Dr. Scholz:  [11:31] Another thing to be aware of is that a lot of the doctors that are doing so-called targeted biopsies don’t trust their skills.  Sometimes they don’t trust the MRIs that they’re looking at, and they feel obligated to do a random biopsy on top of a targeted biopsy.  In fact, that’s almost routine.  Those of you that are seeking a targeted biopsy need to have this discussion before you’re on the table in that vulnerable position, and the doctor starts hammering away with biopsy after biopsy.  I personally would express clearly to my physician, prior to the biopsy, that I only want a targeted biopsy and to not include the random portion. 

Liz:  [12:11] So we’re starting with something nonspecific, which is the PSA test.  Then we’re using tests like the OPKO 4K, like MRIs, and targeted biopsies to figure out where that high PSA is coming from. 

Dr. Scholz:  [12:25] What Liz says is exactly right.  The ambiguity of PSA creates a real challenge as to what the next step should be, and people need to be patient with themselves, even with the doctors.  Technology is changing quickly and some doctors get on board early with things, others don’t.  We’re looking to these physicians as our authority figures, and some of them are still kind of locked in the past. So the take-home message here is to go slow, do your research, talk to a lot of people, and familiarize yourself.   Thank God that prostate cancer is a very slow process, and of course it may not even be present, that is to be determined, but the go slow approach is essential in this whole process of figuring out what to do with a high PSA. 

Liz:  [13:21] This can all seem overwhelming and confusing, especially during a time that can be filled with fear and experiencing a lot of different pressures, so we’ve posted a flow chart of PSA screening on our blog.  You can find it at prostateoncology.com/blog.  Before we close, we wanted to address some listener questions we got from our last episode “The Brief on PSA.”  We had a listener email this question in: “What is the difference between a standard PSA test and an ultrasensitive PSA test?”

Dr. Scholz:  [14:02] When you’re reading a PSA on a report, you’ll notice sometimes that (this is only relevant when the PSA is very low) the numbers to the right of the decimal point may read 0.1 or in another report, it might read 0.11, or even in a more ultrasensitive report, 0.111, three digits to the right, indicating very small changes can be measured with what are called ultrasensitive PSAs.  So in men who have had previous surgery and their PSA should be undetectable, ultrasensitive PSA can detect a recurrence at an earlier stage than other technologies can.  Ultrasensitive PSA should be used in almost all cases.   For men with higher PSAs, say above 1 or 2, it’s really not that important whether the PSA has ultrasensitive technology or not. 

Liz:  [15:05] So besides standard PSA and ultrasensitive PSA, another listener was curious if there are other types of PSA tests and which of these are the most beneficial?  

Dr. Scholz:  [15:17] There are actually quite a few there’s something called free PSA or percent free PSA. There’s something called complexed PSA.  These have all been attempts to try and further refine the question that I believe OPKO 4K answers best.  They’re trying to sniff out which individuals with high PSA have a consequential type of prostate cancer that is a cancer that has a Gleason score of 7 or higher.  The complexed PSA, the percent free PSA had some utility, but it’s not as useful as OPKO 4K, or perhaps the SelectMDx that Elizabeth mentioned earlier, or the ExoDx test.  So these other PSAs, which are available are just giving you the same information that any old PSA provides. 

Liz:  [16:07] So when a patient comes to our office, Dr. Scholz isn’t ordering five different types of PSA, he just uses the ultrasensitive PSA test.  Thank you for sending your questions.  If you have further questions, please send them to [email protected].  Thank you for listening.  Please remember to rate, review, and subscribe on Apple Podcasts.