What’s wrong with robotic prostatectomy? What’s wrong with radical prostate cancer surgery?

Uro-heretic Dr. Bert Vorstman taking on prostate surgery

(He’s back. And he’s mad. Love or hate him, Dr. Bert Vorstman again is “rattling the cages to see if the dogs bark”—as he likes to put it. He’s previously written for TheActiveSurveillor.com, criticizing PSAs and Active Surveillance. This time, Dr. V. takes on radical prostatectomies and robotic surgery.

(You’ll find some of his popular columns listed on the homepage at the top of the list. I admire his motto: ‘It's high time someone with balls stepped up to the plate and demanded that we return to scientific principles and stop the bullshit.’

(Note: These are Dr. Vorstman’s opinions. The Active Surveillor does not offer medical advice. Feel free to share your thoughts in a civil fashion. Ask your doctor if you have any questions. H.W.)

By Bert Vorstman, MD

Radical prostate cancer surgery has been promoted by urologists as a “life-saving” treatment for over 100 years. But is this surgery safe? And does it save significant numbers of lives? Or, is radical prostatectomy just another example of an accepted medical practice for which the evidence says no, but doctors say yes? 

Prostate cancer surgery’s origins.

After the discovery of general anesthesia in the mid-1800s surgeons became much more ambitious. The idea for treating prostate cancer with a radical approach developed in the early 1900s because of a convergence of objectives from two other procedures. At Johns Hopkins, William Halsted M.D. recommended the excision of breast cancer along with large amounts of adjacent muscles and tissue - a radical mastectomy. (This surgery has since been abandoned because it was both crippling and failed to save significant numbers of lives).

(Dr. H.H. Young, developer of the radical prostatectomy.)

On the other hand, bladder stones had been removed since ancient times with an in- front-of-the-anus incision (without general anesthesia). And, since the prostate is located at the base of the bladder, surgeons used this approach to reach the gland. It was this marriage of an in-front-of-the-anus incision (already described by others) and Halsted’s advice to remove tissue surrounding a cancer that led H. H. Young M.D. (also at Johns Hopkins) to develop his radical perineal prostatectomy. 

(Dr. Bert Vorstman.)

Early radical prostatectomy.

Dr. Young published the results of his radical prostate cancer surgery in the 1905 bulletin, Johns Hopkins University, “The Early Diagnosis and Radical Cure of Carcinoma of the Prostate.” Despite the title’s swagger, there was no evidence for early diagnosis of prostate cancer, and there was zero evidence for cure. Even more dishonest was Young's conclusion that the four cases in which the radical operation was done demonstrated its “simplicity, effectiveness and the remarkably satisfactory functional results finished.” In stunning contrast, Young described the deaths of his first two patients and the significant urinary problems suffered by the other two after prolonged hospital stays. And, although not recorded, it’s likely that those who survived were also left impotent.

The quest to “perfect” radical prostatectomy.

Before the 1950s, trial and error surgery (“surgical innovation”) was easily undertaken as patient protective measures and institutional review boards were not in place. It was only the Hippocratic Oath and its principles of keeping patients from harm and injustice that kept most physicians in check. At times, however, egos and the weight of institutional authority caused some surgeons to stray towards surgical experimentation. 

Emboldened by Young’s claims of curative radical prostatectomy, a few urologists were intrigued enough to continue working on “improvements” to techniques for prostate removal and minimizing complications. Other entry points to the prostate were described from postero-lateral perineal to suprapubic and, eventually, an in-front-of-the-pubic bone or retro-pubic approach. However, despite these changes, cutting out the prostate still led to many nasty bleeding, incontinence, and impotence complications.

In 1982 Patrick Walsh M.D., (also from Johns Hopkins) suggested that erections could be “preserved”  if the operation was slightly less radical so that the tiny nerves lying close to the prostate and important for erectile function could be “saved”. However, despite this “nerve-sparing” approach, impotence and other health dangers remained distressingly common. Illogically, these many complications and the lack of evidence for life-extension failed to deter urologists from promoting this treatment belief as a standard-of-care.  

Robotic prostatectomy origins.

Robotics entered the surgical landscape after being FDA (Food and Drug Administration) approved in 1999. However, this approval was concerning on several levels. First, the results of a low-level clinical study that had been conducted in Mexico were accepted by the FDA despite investigational review and ethics boards being less rigorous than in the U.S. Second, the study recorded zero benefits for the robotic device in gallbladder and gastric fundo-plication surgery. Third, the FDA approved the device only because it “demonstrated the potential for future enhancements to surgery.”

Nevertheless, the robotic market for gallbladder surgery never developed because laparoscopic approaches for gallbladder removal proved easier than robotic methods. Undeterred, the robotics makers eventually closed in on urologists who were testing laparoscopic approaches and still mesmerized by the illusion of curative radical prostate cancer surgery. Seeing that urologists were keen to jump aboard the robotics bandwagon it was just a simple matter to employ the FDA’s fallacious 510(K) process and generate an automatic authorization. By using the bogus claim that the device to be used for robotic prostate cancer surgery was “substantially equivalent” to the device used in robotic gallbladder surgery, the robotics tool was quickly approved for robotic prostatectomy in 2001. A sham approval that was unsupported by clinical data for safety and benefits and ignored the huge differences between robotic gallbladder surgery and robotic prostate cancer surgery. 

Radical prostatectomy complications.

Unsurprisingly, aside from a smaller incision and shorter hospital stay, the move from open to robotic radical prostate surgery didn’t decrease the list of potential complications and quality-of-life issues. Instead, the robotic technique simply added to the list with trocar and positioning injuries as well as insufflation embolism. (Insufflation is blowing gas, such as carbon monoxide, into a body cavity.) Also, there were general complications possible, such as deaths within 30 days of surgery, thromboses, embolism, and suicidal depression after either open or robotic prostatectomy.

And, for both procedures there were many potential complications specific to cutting out the prostate. These included loss of libido, loss of manhood, incomplete or total loss of erections (impotence), lack of emission, lack of ejaculate, ejaculation of urine, pain on orgasm, infertility, shortened penis, penile pain, penile numbness, penile curvature, penile wasting and the possibility of testicular pain.

Additionally, there was the likelihood of bladder problems with urinary leakage (incontinence), bladder neck scarring, bladder stones and urinary tract infections. Also, some 11 to 48 percent of subjects had residual cancer or positive margins because of incomplete removal of the prostate cancer. Understandably, the FDA’s MAUDE (Manufacturer and User Facility Device Experience) site recorded a sizable uptick in adverse events associated with the robotic device for prostatectomy. Obviously, you couldn’t cut out the prostate and live like you did before. A reality that simply made a mockery of informed consent, shared decision-making and prostate cancer awareness (a program without evidence for saving significant numbers of lives).

Complications and managing expectations.

Complications are very common to both open and robotic prostatectomy. (There’s a long list of warnings and disclaimers by the makers concerning their device). However, instead of recognizing the fact that this radical prostatectomy treatment philosophy was associated with many bad outcomes, urologists chose instead to focus on managing expectations and treating the many downsides. They went to great lengths to develop preoperative and postoperative counseling and rehabilitation programs so patients could be mentally prepared for bad outcomes.

However, these preoperative and postoperative programs for penile and bladder rehabilitation were not always successful. Incontinence often required treatment with pelvic floor exercises, medications, catheters, pads, biofeedback, bulking injections, slings, electrical stimulating implants, or artificial sphincters. Impotence commonly required treatment with medications, suction or vibration devices, urethral suppositories, penile injections or penile implants. Failures of these implanted devices resulted in even more corrective surgery, costs and suffering while the patient struggled to maintain a relationship with a loved one. Sadly, the wives, girlfriends or partners, quickly realized that they, too, were the victims of health robbery.

Radical prostatectomy fails to cure.

Irrationally, the radical prostatectomy treatment philosophy is still considered standard-of-care by urologists, although it has never been proven to save significant numbers of lives. In 2012, physicians concluded that through at least 12 years of follow-up that radical prostatectomy did not significantly reduce all-cause or prostate-cancer mortality, as compared with observation. In other words, whether the cancer was treated or not, survival was about the same. In 2023, surgeons concluded that after 15 years of follow-up prostate cancer-specific mortality was low regardless of the treatment assigned. In other words, irrespective of the type of treatment “option” (radiation or surgery or “active monitoring”), survival was about the same. That is, no significant numbers of lives were saved by surgery or radiation. (Dr. Horan had already reached this conclusion in his 2009 book.).Even worse, we have no evidence that any treatment, including focal treatment (cryoablation, high-intensity-focused-ultrasound or laser), de-bulking or salvage surgery for residual prostate cancer, or active surveillance leads to significant life-extension. 

There are several factors in play as to why prostate cancer studies are typically unreliable. The studies are often founded on proving preconceived notions (that is, surgeons with a mindset that radical prostatectomy is safe and curative) instead of being founded on sound scientific principles to generate reliable and reproducible data. And, the studies are invariably corrupted by elementary study design flaws such as the commingling of participants with various Gleason grades and scores (made worse by disagreements amongst pathologists); unknown tumor volumes; inclusion of the Gleason grade 3 (as in 3+3=6) pseudo cancer; a preponderance of low-risk cancers when it’s essentially only the 10-15 percent of high-risk prostate cancers that are responsible for the 30,000 or so deaths each year in the U.S.; staging using imaging studies that are insensitive for detecting small volume cancer spread; the arbitrary use of antiandrogens (testosterone suppression) in some subjects and the relatively short follow-up time frame when low risk cancers can take about 40 years to grow to 1 cm from the time of mutation. And occasionally, skewing the results even further is the use of self-serving definitions of success such as the labeling of a subject as dry if only one pad per day was used. Clearly, junk science is capable of delivering desired results as well as a semblance of cure. 

Misguided prostate cancer guidelines.

Clinical practice guidelines are meant to help physicians deliver appropriate care for the benefit of patients. These healthcare guidelines are a form of patient protective measures. However, despite the vast amount of clinical evidence that both PSA testing and robotic prostatectomy are unsafe and fail to save significant numbers of lives, urology guidelines are packed with recommendations for their use. As well, American regulatory (FDA, CDC, NIH) and other cancer organizations (NCCN, NCI) are supposed to offer an even higher level of patient protection. Yet, these many agencies, societies and organizations appear to have simply regurgitated the same unsafe and unproven recommendations found in the urology guidelines. Surprisingly, the only organization that attempted a non-partisan evaluation of PSA testing and the treatment of screen-detected cancers was the USPSTF (United States Preventive Services Task Force).

The USPSTF (an independent panel of national experts in evidence-based medicine) pushed back on PSA-based screening with a “D” grade in 2012. They concluded that “prostate-specific antigen–based screening results in small or no reduction in prostate cancer–specific mortality and is associated with harms related to subsequent evaluation and treatments, some of which may be unnecessary.” That is, the benefits did not outweigh the harms. Disturbingly, this important ruling was quickly challenged and watered down to an ineffectual “C grade” in 2018 by self-interested urology groups. Shockingly, urologists' own studies had already concluded in 2009 that PSA testing  failed to save significant numbers of lives. Additionally, another recent study also concluded that PSA-based screening did not result in life extension.

What’s wrong with prostate cancer surgery? Everything.

Radical prostate cancer surgery and PSA-based testing remain central to the urologist’s prostate cancer ideology. However, the clinical evidence shows clearly that radical prostatectomy and the many other prostate cancer practices recommended by urologists are unsafe, fail to deliver life-extension, and need to be thrown out. Especially egregious is the abject failure of the American regulatory apparatus to protect unwitting consumers. Instead, a toxic combination of flawed science and intellectual dishonesty has been allowed to sacrifice the health of the vulnerable. Until urologists find new tests and treatments that are safe and save significant numbers of the 10-15 percent that have potentially lethal cancer, the current prostate cancer dogma stokes only an indefensible public health disaster.

Read more - These books should be required reading for any patient or physician (particularly academic urologists and urology residents) entering the prostate cancer arena.

The Rise and Fall of the Prostate Cancer Scam by A. Horan M.D.

The Great Prostate Hoax by R. Ablin and R. Piana.

Time is running out to enter the Gleason prostate humor contest

By Howard Wolinsky

Entries for the Gleasons—Putting Glee in Gleason Scores humor contest will be accepted through 11:59 p.m. Friday, Sept. 15. Send your one-liners, cartoons, puns, limericks, poems, to me at howard.wolinsky@gmail.com.

We play blue—in the sense of prostate jokes, not necessarily in terms of politics. Doctors and patients alike can enter. We are not focused on prostate cancer, BPH and other ailments along with prostate exams are fair game. Tell us what the collective noun (like a murder of crows) is for a large number of prostates,

We will announce the winners soon and will award valuable prizes, including a shirt with a Gleason 6 pattern, a golf shirt from the Walnut Foundation, a plush prostate doll, a prostate keychain, and autographed books on the prostate.

Read more here:

Catch these PCa webinars

—Active Surveillance Patients International (ASPI) is sponsoring a free webinar on lifestyle research and low-risk prostate cancer from 12-1:30 p.m. Eastern, Saturday Sept. 30. Register here for “Applied Research and Lifestyles and Low-Risk Prostate Cancer: https://zoom.us/meeting/register/tJwvdOGoqjwuE9CC8AI45nYdsj63e-iUnop6

The program features Drs. June Chan and Stacey Kenfield from UCSF.

(Stacey Kenfield, ScD.)

—PHEN (Prostate Health Education Network) will address issues relating to AS and Black men in a webinar, the 19th Annual “African American Prostate Cancer Disparity Summit.” https://tinyurl.com/mu7ebh4d

—Focal therapy? Listen to AS pioneer Dr. Laurence Klotz: https://ancan.org/webinar-is-focal-therapy-right-for-your-prostate-cancer/

—Lifestyle? Catch ASPI’s webinar with Dr. Stacy Loeb, of NYU, on lifestyle factors, such as diet. Great talk on a plant-based diet: https://aspatients.org/meeting/as-101-program-on-diet-and-nutritional-lifestyle/

—DNA. Todd Morgan, MD, chief of urologic surgery at the University of Michigan (Go Blue!) presented a great program on genomics to an AnCan webinar on Aug. 31. The video is available now for your viewing: https://ancan.org/webinar-how-and-why-prostate-cancer-genomic-tests-work/