Ethics of giving 'em what they want
By Howard Wolinsky
Some urologists are heaping scorn upon some German doctors who enabled patients to bypass biopsies and head straight into surgery.
The researchers call the procedure “biopsy-free prostatectomies.” And critics are having no part of it. They suggest it’s irrational and unethical.
I’m raising questions here about urologists and radiation oncologists treating patients with radical procedures when they know they are candidates for active surveillance (AS), close monitoring.
Are biopsy-free prostatectomies comparable in a way to operating on or exposing to radiation patients with low-risk prostate cancer?
Some will say that’s apples and oranges. But hear me out and let me know what you think.
A news report came out in MedPageToday this week on a four-month-old study of such patients, who feared that a biopsy would spread their cancer—supposedly an unfounded fear—and so they asked to go straight into the OR and skip biopsies.
This surgery was based on imaging only, not imaging AND pathology.
TheActiveSurveillor.com spoke to one of the surgeons back in March about this study. These men determined to undergo surgery based on unfavorable mpMRI and/or PSMA PET results so they took a leap and decided to not bother with biopsies and plunge into surgery. The researcher informed me that these patients feared that biopsies would spread cancer—a controversial view.
Valentin Meissner, MD, of the Department of Urology, Technical University of Munich, School of Medicine, said: “The reasons for not having a biopsy were not assessed routinely, and it was not me who talked to the patients preoperatively. However, I had the chance to speak to some patients who refused the biopsy, and one reason that was mentioned several times was that patients were worried about tumor spreading.”
This concept is called “seeding. The surgeon was skeptical about this but performed the surgery anyway.
Meissner added: “Although the risk of spreading tumor cells seems to be very low and not common in prostate cancer, there are no valuable data available on this issue. Another point was that patients refused active surveillance or other procedures anyway, so for them, the biopsy was regarded as a waste of time.”
Eyebrows are being raised in respectable corners of urology.
Prof. Hashim U. Ahmed, chair of urology and consultant urological surgeon at Imperial College Healthcare in London, tweeted: “This retrospective series, NOT approved by an ethics committee, should have brought about more outrage than the ENACT RCT of enza in AS.”
(Note: For the record, the German surgeon said an ethics committee signed off on his work.)
(Ahmed is referring to another recent and highly scorned study, ENACT, in which the toxic drug enzalutamide was given to patients who otherwise would qualify for active surveillance. Ethics committees also approved ENACT. Cancer was suppressed with a drug typically given to patients with higher-grade prostate cancers, but the patients experienced extreme fatigue and many grew breasts. )
Here’s what I have reported on ENACT so far:
I’ll be writing more about this soon.
Of the biopsy-free prostatectomies, Ahmed went on: “What exactly was aim? Pandering to patient fears that biopsy spreads cancer? Need to investigate that concern not bypass it in this way…”
This retrospective series, NOT approved by an ethics committee, should have brought aAugust 2022 Issue Radical Prostatectomy Without Prior Biopsy Following mpMRI and PSMA PET https://buff.ly/3EHeBsn Editorial: Radical Prostatectomy Without Biopsy: Audacious, Imprudent, or Innovative? https://buff.ly/3Iq41bM
(The tweet.)
Others described the paper as bold and innovative. But some said the ethics seemed shaky.
A reader, an economist treated for high-risk prostate cancer, made an interesting point about the German patients who skipped the biopsies: “The logic of these patients is silly. If you‘re worried that a biopsy will spread cancer, then you should be even more worried that surgery will (and there are real reasons for believing that!). Or that surgery leaves malignant cells behind on the resection borders.
“Logically, these paranoid patients should be opting for AS or RT, not surgery. It‘s irresponsible of their urologists to support their delusions.”
Parth Modi, MD, and his colleague Scott Eggener, MD, my former urologist at UChicago, wrote an editorial: “Radical Prostatectomy Without Biopsy: Audacious, Imprudent, or Innovative?”
They said: “This study raises important and interesting ethical questions. How were these patients counseled? What risk of no cancer or low-grade cancer on final pathology were the patients led to expect? Should the surgeons simply have refused to perform surgery without a definitive diagnosis of prostate cancer? The authors appropriately obtained institutional review board approval to analyze and report this series. However, it is not clear if there was any oversight required or obtained before proceeding with surgery in these patients.”
I have a different question for the urologists and radiation oncologists who may be sneering at the German doctor and patients.
The German doctors gave their patients what they wanted.
No doubt most of urologists and radiation oncologists have performed radical surgery or delivered radical radiation therapy to patients who were clearly candidates for Active Surveillance.
How do you justify that? Are these decisions really qualitatively different from what the German docs did with biopsy-free prostatectomies?
They too are giving patients what they want.
So far, backed by insurance companies, patients have a choice in these matters. There are no forced AS cases.
Patients who have undergone biopsies and qualify for Active Surveillance often (too often still) elect to undergo prostatectomies or radiation therapy, risking side effects such as impotence and incontinence.
The number of patients who could opt for active treatment remains quite high, according to the latest statistics from the AQUA registry from the American Urological Association.
A whopping 40% of U.S. patients with low-risk prostate cancer who qualify for Active Surveillance still choose to undergo radical treatment. Outrageous. Only 4% do that in Sweden and Holland.
That’s much better than it used to be. When I started on AS in 2010, 94% of patients like me with low-risk Gleason 6 opted for these radical treatments, urged on by their urologists and their families.
So let me ask, the doctors: Do you look down on the urologists who enabled some patients to skip biopsies for what may seem like irrational reasons?
Is it any more rational to enable patients who qualify for AS to go under your knives and radiation beams?
Is it really ethical—remember First, Do No Harm— to offer surgery or radiation to patients who likely don’t need it and who can be monitored to determine if they do? Can’t you do something to overcome high anxiety that encourages patients to skip AS?
To paraphrase a wise Italian psychologist: Prostatectomies and radiotherapy don’t cure anxiety.
Again, for now, I favor patient choice between AS and other options until there are better ways of predicting which patients can expect their cancers will become aggressive.
Use the comment box above to share your opinion.
Meanwhile, come to the ASPI program on diet: “Eat to Beat Prostate Cancer,” at 12p.m. Eastern July 30 featuring Dr. William Li, a famed TED talker on diet and cancer.
Free Registration: www.aspatients.org or go to: https://bit.ly/3t5lFLx
Free prostate-healthy recipes for all registrants.
More info: info@aspatients.org; or DrDavidKingKeller@gmail.com
Join Dr. Channing Paller, associate professor of Oncology and Urology at Johns Hopkins University, Sidney Kimmel Comprehensive Cancer Center, and Rob Finch, Director of Urology Medical Affairs at Myriad Genetics as they discuss the impact of genetic factors in prostate cancer and the PROMISE study.
Genetics, the PROMISE Study, and Prostate Cancer: a Town Hall Webinar
July 20, 6:00 p.m. - 7:00 p.m. Eastern Time
Register: https://bit.ly/3ypgAzr
To sign up for the free test, go to:
prostatecancerpromise.org
Join a ZERO webinar, Prostate Cancer and the Unique Needs of the LGBTQIA+ Community featuring Anne Katz PhD, RN, FAAN, of CancerCare Manitoba, Winnipeg. The program will be held July 27, 2022 at 6:30 p.m. Eastern.
Register here: https://us06web.zoom.us/webinar/register/WN_eUvLX0yNSAmRe5b-ST7zeg.
The elephant in the US community medical office is financial conflict of interest!
Beyond the broad 'ethics' reference, it is not named per se.
As advocates, we must repeatedly remind community urologists and radiation oncologists treating prostate cancer that we are on to them. It is not just about amortizing their very expensive equipment and paying their bills.
The more we as patient advocates remind practitioners, and the more patients question why a procedure is necessary, the more likely we'll drop that 40% rate to 4%.
In a general sense, all of this has to do with a lack of understanding about prostate cancer. Education about PCa should ideally begin in the primary care physician's office where there should be adequate information concerning the PSA that your PCP recommends. And then there, and not only in the urologist's office, information concerning PCa should be available. Etc., etc.