MRI and Biopsy Results: PI-RADS, Gleason and PCa

The waiting is brutal.  Three weeks ago, I was shown my prostate TRUS MRI fusion results.  I was given a PI-RADS score of 4 on a scale of 5, with a 5 being most likely for cancer.  For reference, ten years ago, my MRI report score was a  PI-RADS 1, or “highly unlikely” to have clinically significant cancer.  A score of 4 means that, “Clinically significant cancer is likely to be present.”  The modified scale used by the NIH was only slightly better, “Moderately likely for prostate cancer.”

As you can imagine, it considerably freaked me out to learn this in the hours of worrying while I waited to be taken for my biopsy procedure.  On the plus side, it also told me that I was doing the right thing.  A half-centimeter size lesion was shown on the MRI, and a random biopsy might miss that small of a lesion altogether.  Armed with the MRI results, they were able to precisely target this tumor with two separate biopsy samples from different angles, along with 12 other random cores to see if cancer was present or had spread elsewhere in the prostate.  Ten years ago, I did not have any cancer, nor was any type of lesion or tumor indicated on the MRI.   Things were not  nearly as promising on this one:

Making lemonade out of lemons, the fact that only a single lesion was present was relatively good news.  Plus, there was no indication it had spread beyond the prostate or into any other tissues within the prostate.  These might all be positive considerations for less invasive focal treatments.  There are a number of studies out there showing the correlation of PI-RADS to biopsy results for cancer.   Thankfully, it seems that a PI-RADS score of 4 isn’t nearly as bad as a score of 5, but on a scale of 1-5, even a 4 feels pretty bad to a patient.   The correlations for a score of 4 just aren’t as well established yet, and that’s why these studies continue.  On the other hand, a PI-RADS score of 5 is usually bad news and has a much higher correlation to cancer.

Suffice to say that while a score of 4 does not usually indicate the presence of the most aggressive cancers (Gleason score of 8 or more), it often shows concerning cancers with a Gleason score of 7.  PI-RADS 4 lesions also can be benign or less aggressive cancer with a Gleason score of 6 or less.  In plain English, based on the MRI results and on various studies I have read over the three longest weeks in my life, I figured I had about a 50-50 chance of having a clinically significant cancer that required some sort of treatment in the near future.  For the optimist, maybe only a 40% chance or even a bit lower, depending on which study you read and whether or not the physician recommends treatment for Gleason grade 7 cancers.

Yes, I intentionally put off discussing my biopsy results to the end of this article.  This was to give anyone reading only a tiny fraction of how it feels to wait THREE WEEKS after seeing a PI-RADS score of 4 on my MRI.   Some days it has been almost paralyzing to wonder why it was taking so long, when I was originally told 5-8 business days.  Were the results so bad that a second opinion on the biopsy cores was needed?  Did they have to develop a treatment plan before contacting me?  Was a radical prostatectomy and all its risks, side effects and quality-of-life issues now a given for me in the near future?  Yeah, that stuff and worse goes through your mind every night at 3am, and even during the day.

I am both blessed and greatly relieved to say that I dodged a second bullet, both in terms of infection and biopsy results.  My phone call came an hour ago and NO cancer was indicated in the results.  Presumably, the targeted lesion is simply a benign tumor or other abnormality, one to be monitored for changes in the future.

Of course, prostate biopsies have a significant false negative rate.  Even with MRI/Ultrasound targeting guidance, they can miss cancerous cells that exist elsewhere in the prostate.  Sadly, no better diagnostic exists today, which is why I participate in this NIH study.  Trans-rectal prostate biopsies are not at all pleasant, and if you get a resistant infection, they can even be fatal in rare cases.  Improving non-invasive diagnostics like MRI, blood and urine tests is critical to reducing the need for random rectal biopsies that seem like a holdover from 1960s medicine.

Suffice to say I am very thankful to God, the universe and to the NIH/NCI Urology team, not only that no cancer was found and that I have no major side effects of the biopsy, but also that I hopefully don’t have to see them again for many years!

 

 

Is Active Surveillance a Good Choice?

Given the risks of prostate biopsy and the major potential side effects of a radical prostatectomy, many men are choosing to monitor their prostate symptoms, rather than seek invasive treatments.  The decision to pursue Active Surveillance (AS) varies based upon a number of factors and should be carefully discussed with physicians.

https://www.sciencedaily.com/releases/2019/02/190211182853.htm

https://www.renalandurologynews.com/prostate-cancer/prostate-cancer-active-surveillance-is-a-viable-option-for-men-younger-than-60/article/829682/

“AS is a safe and effective approach which spares any properly selected men younger than 60 years with low risk prostate cancer from intervention, provides adequate time for intervention if required, and shows durable disease specific survival.” 

Transperineal or Transrectal Prostate Biospy

If you are like me, the thought of serious infection or sepsis is a very scary prospect if you must have a prostate biopsy.  Prostate cancer is bad enough, but it usually isn’t an immediate threat and is often treatable.  Sepsis is a very real and very urgent life-threatening risk.  In the case of resistant bacteria, treatments may not be guaranteed.

Here is a nice guide to compare trans-rectal (TRUS) to trans-perineal biopsies (TPB):

Transrectal or transperineal biopsy: which is best?

There is apparently less risk of infection for this type of biopsy that goes in through the skin under the anus, rather than from inside the rectum.   It may also allow for better sampling of some areas of the anterior prostate, such that it’s the preferred method when extra cores saturating more of the prostate are needed. The main drawback seems to be that it is usually done under general anesthesia, which isn’t necessarily a bad thing in my experience.  This does usually mean at least one night in the hospital in many cases.   I have survived two trans-rectal biopsies without infection, but consider myself lucky. I will seriously consider a TPB in the future if the option is available.

Prostate Biopsy Recovery, Side Effects & Complications

My Personal Experience with Trans-Rectal Ultrasound MRI Fusion-Guided Prostate Biopsy: A Guide of what to expect after your prostate biopsy.

Since 10 years ago, there is a lot more information on what to expect after your trans-rectal ultrasound (TRUS) prostate biopsy.  Back then, many websites omitted some key side effects, such as blood in your ejaculate.  Even some very reputable health and medical websites buried things like the possibility of serious infection or sepsis as a small bullet point.  It turns out, this is a very real, increasingly likely and possibly fatal complication.  Urinary infection or inability to urinate are also possible complications.  Urinary incontinence and erectile dysfunction are less common risks.

Of all the potential side effects, I was most shocked 10 years ago when my semen looked like thick blood because it wasn’t on my care sheet or mentioned by the medical staff.  So, I created an article back then to help others that generated over 600 comments. Please feel free to reply with your experiences as a comment after this article, you are welcome to use an anonymous username and email. Thankfully, more websites and care sheets acknowledge blood in the semen now compared to a decade ago.   This is good because if you aren’t expecting it, you might think you have a serious bleeding issue or internal hemorrhaging.   You aren’t. Opaque red or rust-colored ejaculate is not unusual after a prostate biopsy and can last a month or longer after the procedure, hopefully diminishing over time and number of ejaculations.  Even my doc, nurse and care sheet mentioned it this time, unlike 10 years ago.

This new care sheet is pretty good based on my experiences.  Here is another reasonable webpage more centered on the risks, except that “…you also may see traces of blood in your semen” doesn’t come remotely close to describing it for some men:

https://www.pcf.org/c/biopsy-things-you-need-to-know/

How common is hematospermia (or hemospermia)?  One report indicated that various studies showed that between 5% of men and 90% of men had blood in their semen after a biopsy.  When eliminating men who did not ejaculate after the procedure, they found about 90% had blood in the semen that lasted around 4 weeks and 6 ejaculations after the procedure.  A similar study had very similar results.  As you can see in these studies, it is not all that uncommon to have blood red semen, rather than having a tint or “altered color.”

I’m going to discuss my own, personal recovery experience following my second TRUS guided prostate biopsy, done under local anesthesia.  It was pretty similar to my first one.  If you are squeamish or don’t like the TMI type of details, STOP READING NOW.  The rest of this article is definitely Too Much Information unless you really want to know from first-hand experience. Continue reading Prostate Biopsy Recovery, Side Effects & Complications

2nd Visit to NIH for UroNav fusion MRI/TRUS Prostate Biopsy

My Personal Experience on What to Expect During a Trans-Rectal Ultrasound Prostate Biopsy Under Local Anesthetic

Almost 10 years ago, I headed to the National Institutes of Health, National Cancer Institute for a 3T MRI/Ultrasound fusion Prostate Biopsy. You can read about it here: https://www.prostatebiopsyblog.com/first-day-at-the-nih/

This week, I made a second visit due to increasing PSA levels. I again flew into Reagan airport in Washington DC.  I used the DC Metro for everything, no need for cabs, buses or ride shares.  Last time, I stayed at the Hyatt Regency Bethesda, which is literally right on the Metro, 1 stop from NIH.  This time, I found a much better rate at the nearby Hilton Garden Inn Bethesda, about a 2 block walk from the Metro, also easy and very reasonable.

After arriving at NIH, I started with blood and urine tests, an EKG and an IV for administering contrast during the MRI.  No chest X-ray was done this time. The MRI sure seemed longer than I recall from last time, but was apparently done in about half the time at just over 30 minutes of motionless time on my back.  Thankfully, they apparently no longer use the endorectal coil, which was as unpleasant as it sounds.  MRI results were not in by my appointment later in the afternoon, but given my history, the resident physician at the consultation confirmed that a biopsy was indicated.  I had pretty much assumed that.  Last time it was unpleasant, but this time was going to be local anesthesia rather than general, so I was still anxious.  My PSA level was 4.7 in their test, a bit lower than before but still within daily variations.

So, the next morning, I started at 5AM with the enema, unpleasant in itself.  After my bowels calmed down, I arrived at the NIH at 7AM for my 7:30 am appointment.  And waited, and waited, and waited.  Others arrived later but had their procedures earlier, including one gentleman who was clearly angry when he hadn’t been admitted 15 minutes after he sat down for his 9:30 appointment and began demanding to be seen with every nurse that came into the room.  I was about to tell him I had been there almost 3 hours already, when a nurse came to have me fill out some paperwork.  I also then asked if my MRI results were available and she went to get them.  As she returned, she also gave the other gentleman his forms to complete, and then he was off to OR before me…  Squeaky wheel, as they say.

Here is a very good guide on the procedure from a physician’s perspective:

https://www.verywellhealth.com/the-prostate-biopsy-what-to-expect-2782256

The 5 hours waiting for the procedure was also pretty difficult for me, but eventually, my name was called just after noon.  Basically, under general, you’re wheeled in, put to sleep and wake up in post-op.  Under local anesthesia, it’s a bit different.  Okay, a lot different.  Here it is from a patient’s perspective. If you don’t want the details, don’t read on.  STOP HERE.

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. Continue reading 2nd Visit to NIH for UroNav fusion MRI/TRUS Prostate Biopsy

More Testing

Almost 10 years ago, I headed to the National Institutes of Health, National Cancer Institute for an MRI/Ultrasound fusion Biopsy. You can read about it here: https://www.prostatebiopsyblog.com/first-day-at-the-nih/

Since then, despite knowing that PSA is a poor indicator of prostate cancer, I have followed my physician’s suggestion to continue to monitor it yearly. It has increased roughly linearly, about 10% each year. It was just over 5.1 when it was tested early in 2018, and my physician referred me back to my urologist. All my digital rectal exams had been negative in the years since, and the new one was also negative, thankfully. Even so, he suggested it was time for more testing, starting with a newer 4KScore blood test, possibly followed by an MRI and biopsy if indicated.

It seems the 4KScore test is not covered by all insurance as it is not universally accepted as a good predictor of prostate cancer yet. With my high deductible insurance, it would have cost over $400.  So ,I sought a second opinion with the physician who treated me at the NIH 10 years ago.  He had no opinion on the 4KScore, but offered a followup MRI/biopsy like the one I had previously through a trial.  As there is no cost in these trials and most travel expenses are also paid in full or part, my cost for both procedures would be less than the 4KScore blood test.  So, it seemed like the way to go since MRI/biopsy is the only way to be more sure anyway.

I still think prostate biopsies are a draconian test.  Piercing the rectal wall to take random tissue sample that can’t sample some areas of the prostate and may miss a cancer even in sampled areas seems like 1950s medicine.  Risking sepsis, urinary retention, urinary infection and other side effects for a test that has a legitimate false negative potential is also concerning, and the risks are increasing.  What used to be a 1-2% risk of an expensive ER visit for possibly fatal infection may now apparently 3-5%, in part due to E Coli bacteria resistant to the preventative antibiotics used prior to the procedure. Unfortunately, there still isn’t a better way, though MRI technology has improved, in part due to the trial in which I participated.  So, back to Washington DC I go…

Fusion Biopsy Study

About 10 years ago, I had an MRI/Ultrasound fusion biopsy done at the National Institutes of Health under a study developing this technology. The hope was that it could not only improve the detection of prostate cancer from the archaic random sampling method, but eventually lead to effective non-invasive testing. This newer study of the results shows that the technology is improving. There is also an indication that the technology may help focal therapy techniques to avoid the radical and sometimes unnecessary major surgery to completely remove the prostate.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5938261/


Among men undergoing biopsy for suspected prostate cancer, targeted MR/ultrasound fusion biopsy, compared with standard extended-sextant ultrasound-guided biopsy, was associated with increased detection of high-risk prostate cancer and decreased detection of low-risk prostate cancer. Future studies will be needed to assess the ultimate clinical implications of targeted biopsy. “

Focused Prostate Cancer Drugs: Sophiris Bio and Steba Biotech

In the last decade, focal treatments for prostate cancer and BPH have appeared as an alternative to major prostate removal surgery.  Many of these use a minimally invasive surgical technique to ablate portions of the prostate.  These may use cryo (cold), laser (heat), HIFU (heat/ultrasound), NanoKnife (electrical) or radio frequency (heat) techniques to kill localized tumors and surrounding tissue.  Some of these techniques are already approved in the United States, while others are available in Europe, Mexico or other countries.

In the last few years, companies have also developed focused drug delivery systems to treat BPH and/or Prostate Cancer.  These include  PRX302 from Sophiris Bio and TOOKAD from Steba Biotech.

PRX302 (Topsalysin) has already completed a Phase III trial in the USA for treating BPH, or Benign Prostatic Hyperplasia (prostate enlargement).  It recently competed a Phase IIa trial for treating localized PCa, or Prostate Cancer.  It has just started a Phase IIb trial in the USA for PCa.  Topsalysin is injected into the prostate to minimize affects on other areas of the body.  It is activated by PSA, made only by prostate cells.  Once activated, it causes death of affected prostate and prostate cancer cells.  Sophiris Bio is based in Canada and trades on the NASDAQ as SPHS.

http://www.sophirisbio.com/prx-302/

TOOKAD® (Padeliporfin) is also injected directly into the prostate in low risk, localized prostate cancer patients.  It recently completed Phase III trials in Europe and in Latin America and is now available in Mexico.  Once injected, near-infrared light is applied to the tumor, activating the drug and releasing toxins that destroy surrounding blood vessels and cancerous cells.  Steba Biotech is based in Luxembourg, France and Israel and is privately owned.

http://www.stebabiotech.com/index.php/TOOKAD-R-Soluble/What-is-focal-treatment-for-prostate-cancer

The traditional treatment for prostate cancer, radical prostatectomy, removes the entire prostate along with a section of the urethra and the internal sphincter that is used in the process of urination and ejaculation.  Obviously, this kind of major surgery has possible side effects involving sexual function, urinary continence, infection and even damage to the rectum.  Localized focal treatments generally reduce or avoid these risks and may even be performed on an outpatient basis.  The disadvantage is that they may not offer as high of a cure rate for the cancer, since some of the prostate may be left intact .  Fortunately, many of these focal treatments can be repeated or followed by a radical prostatectomy, if necessary.

Focal Prostate Cancer Therapy

Many prostate cancer patients undergo a prostate removal, or radical prostatectomy, either by conventional surgery or using the robotic da Vinci system.  What doctors may not tell you is that either method not only removes the prostate gland, but an entire section of the urethra, including one of the valves important to maintaining continence and sexual function.   This “internal sphincter” is important not only for urination, but also for ejaculation .  Complete removal and resection of the prostate and urethra is a somewhat draconian response to what is usually a tiny tumor in once small section of the prostate.

Of course, the problem is that it is difficult to locate exactly where the tumor is, if there is more than one tumor, or if it has started to spread, so many doctors simply suggest a complete removal.  Prostate Biopsies suffer from false negatives and are as controversial as complete removal of the prostate.  A radical prostatectomy is not unlike completely removing the breast in a mastectomy for a small tumor where a lumpectomy might be an alternative.

Fortunately, there are now some methods that focus on removing just the tumor, rather than the entire prostate along with a section of the urethra and the internal sphincter that helps with urination and ejaculation.  Patients should be informed about all these options.  From the highly regarded Sloan Kettering Cancer Center, these include:

  1. Focal Cryoablation (Cold treatment)
  2. HIFU (High Intensity Focused Ultrasound) (Heat treatment)
  3. NanoKnife (Electrical Treatment)
  4. Vascular Targeted Therapy (Drug treatment)
  5. MRI Guided Laser Ablation (Laser/Heat Treatment)
  6. Radiofrequency Ablation (RF/Heat Treatment)

Less than 10 years ago, these focused therapies were not even available to patients in the United States.  Some are now FDA approved, while others are undergoing trials or are available in Europe, Mexico and other countries.   These treatments are often guided by high resolution MRI, ultrasound or by targeted biopsy results.

Unlike radical prostatectomy and radiation treatments, these far less invasive therapies tend to have a lower incidence of major side effects.  On the downside, while still preliminary, their cure rates also tend to be lower.  Fortunately, unlike some radiation treatments, in many cases focal treatments can be followed by radical prostatectomy, if necessary.

Ultimately, these focal treatments tend to be for early and/or low-risk prostate cancer patients.   Some forms of prostate cancer cannot be treated by focal therapies.  Also, not all urologists agree on focal therapies, according to the Urology Times:

“We’re starting to do some investigative studies on this, but it’s still premature to say whether it’s going to be the future.

For low-grade disease, it’s certainly worth a try because nothing is really lost. For high-grade disease, I don’t know that it’s appropriate—we don’t have the data.

It used to be that all grades of cancer were treated either by radiation or surgery. Now surveillance is preferred for low-grade cancer with close follow-up, including repeated prostate biopsies. Rather than having to do that, why not just do focal therapy—HIFU or cryosurgery? I’d rather follow up with PSAs than biopsies.”

Prostate biopsies could be avoided with MRI

https://www.yahoo.com/news/prostate-biopsies-could-avoidable-mris-study-090415741.html

A quarter of men suspected of having prostate cancer could avoid invasive and potentially dangerous biopsies with the help of MRI scans, researchers reported Friday.

Magnetic resonance imaging (MRI) could also reduce the number of men over-diagnosed with the disease by five percent, they detailed in a study published in The Lancet.