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:

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.

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.

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.

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

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.

More PSA Tests

My PSA has risen to 4.4 as of my most recent test, roughly 10% above the test over a year ago.  Anything over 4 is officially considered high for my age group.   My PSA has been rising almost 10% a year on average for almost 9 years.  Best I can tell, this simply means that my prostate has been growing almost 10% a year, most likely due to a common benign condition known as BPH.  A sudden increase on PSA or detection of lumps on a DRE by a physician would likely lead to additional testing.

PSA testing is still controversial, with new studies and policies recommending against routine testing.  There are also experts who still think it is a valuable tool, highlighted by Ben Stiller’s recent comments.

One problem with the PSA test is that it often suggests that men have prostate cancer when they do not have cancer, according to the USPSTF. About 75 percent of men with abnormally high levels of PSA do not have cancer. These so-called false positive results can lead to anxiety and unnecessary follow-up tests, the USPSTF says.



Aspirin and Prostate Cancer

Can Aspirin reduce the risk of aggressive prostate cancers?


The analysis found that regular aspirin resulted in a 24% lower risk of developing lethal cancer after being diagnosed with an early stage of the disease, and a 39% reduced risk of dying from prostate cancer.

But aspirin had little effect when researchers looked at overall incidence of prostate cancer among the participants. “It was after diagnosis of prostate cancer that there appeared to be a benefit,” said Christopher Allard, lead author of the study and a urologic oncology fellow at Harvard Medical School. “It doesn’t affect the incidence, but it affects the progression.”

More on the 4KScore

Since Medscape saw fit to remove their content from our previous post, here’s a newer article about how the 4KScore may help reduce unecessary prostate biopsies:

“The role of the 4Kscore,” explained Sanoj Punnen, MD, an assistant professor in the Department of Urology at the University of Miami Miller School of Medicine and Sylvester Comprehensive Cancer Center, in Florida, “is to determine which patients are most likely to have an aggressive cancer and would, therefore, benefit from … biopsy. This allows us to forgo biopsies in men who are unlikely to ever suffer any serious consequences from a high-grade cancer.”

More on the 4KScore here:

Another new biomarker for prostate cancer

This one is a little different than some others.  University of Michigan researchers may have found a way to distinguish aggressive and less aggressive cancers:

“If this biomarker does indeed control the growth of prostate cells, it’s a new signal that’s not been seen before and could provide a potential new drug target for prostate cancer,” Franceschi said. “It could also be a potential biomarker to discriminate between fast and slow growing tumors.”



The 4Kscore? Is it Better than What We Had Before?

It seems like there is a new test every few months.  I’ve had a few of them as you may have seen in the archives of this blog.  Now there is a 4KScore test,

A newly available commercial blood test performs better than a commonly used online risk calculator in predicting which men with an elevated prostate-specific antigen (PSA) level will ultimately turn out, on biopsy, to have high-grade disease.