A few German patients with more aggressive prostate cancer opt to avoid biopsies and head straight into ORs, new study finds

Are patients going off the rails on the biopsy train?

By Howard Wolinsky

A small group of German patients with suspicions only of high-risk prostate cancer is turning on its head traditional recommendations for biopsies before proceeding with radical prostatectomies..

These patients, seemingly concerned about risks from transrectal biopsies, such as potentially deadly sepsis and other infections, among other things, opted to skip a biopsy altogether and head straight for the OR without considering the possibility that active surveillance (AS), focal therapy, or radiation, would be a better option. 

This news comes out of the current issue of European Urology. German researchers report on a series of 25 men with a highly suspicious presence of high-risk prostate cancer in men who underwent radical prostatectomy without preoperative histologic confirmation of prostate cancer with a biopsy.

The small group had Gleason 3+4 (favorable intermediate-risk prostate cancer or higher) in post-surgical biopsies. Before surgery, the patients had PI-RADS of 4 or higher and PSMA-PET scores of 4 or higher on a 5-point scale.

The patients were strongly advised to undergo biopsies, but adamantly resisted.

(It’s not totally clear to me why after reading the study. But there you go.)

Personally, I am biopsy-averse but would have undergone the extra biopsy to determine if AS or other choices were options before charging into the OR and facing risks of impotence and incontinence. Different strokes for different folks, I guess.

These patients relied on mpMRI imaging--which also is happening in the AS world--even though mpMRI may miss 10% of significant cancers. The study patients also underwent prostate-specific membrane antigen PET scanning, a method currently not available to low-risk patients in the U.S.

This may represent a future path for these patients, but the idea is blowing the minds and challenging the ethics of urologists. As the German researchers asked: Is there a possibility in selected men to avoid unnecessary biopsies before local treatment with RP in cases of highly suspicious imaging results?

Valentin H. Meissner, MD, of the Department of Urology, Technical University of Munich, School of Medicine, and colleagues, stressed: “Results of the PSMA PET were highly suspicious for PC (PET score of >4 on a five-point Likert scale). Both mpMRI and PSMA-PET were negative for distant metastases. After completion of both mpMRI and PSMA-PET, patients had been informed about their high risk of PC and counseled by their treating urologist in an outpatient clinic.

”At referral to our clinic, all patients included in this case series expressed the explicit wish to avoid a biopsy and primarily undergo RP. In all cases, the surgeon himself discussed and explained in detail the usual diagnostic pathway including the necessity to perform a prostate biopsy for histopathologic PC confirmation and, in case of a subsequent PC diagnosis, all possible treatment types including active surveillance, RP, radiotherapy, and focal therapies. Especially, the risk of finding ‘no cancer’ at the RP specimen was discussed and explained to the patient. Nonetheless, every patient wished explicitly:  an RP without prior biopsy despite the recommendation.”

A total of 25 patients were retrospectively identified and enrolled in this case series. The retrospective analysis was approved by an ethics committee.

 Of 25 patients, 14 had an initial suspicion of PC based on elevated levels of PSA and abnormal digital rectal exam (DRE), nine presented with an elevated PSA level, and two had only an abnormal DRE. The median PSA level at diagnosis was 7.3 ng/ml and average age was 70.9.

Biopsy-free prostatectomies is radical idea in a conservative field--one brought on by patients who wanted to avoid the risks of biopsies and go straight to surgery, which poses its own risks. This idea comes just as patients are challenging the use of transrectal biopsies and the frequency of biopsies of all kinds. (One of my many articles on the topic: https://www.salon.com/2021/08/11/a-common-biopsy-is-putting-lives-at-risk-its-time-to-retire-it_partner/)

 We have an important voice in these matters. But has patient power gone off the rails in this case?

To urologists, this is an intriguing idea--skipping an extra biopsy and offering definitive treatment earlier--even after counseling patients to undergo biopsies. 

What’s in it for patients? They avoid the complications of biopsy, reduce psychological burden, and anxiety in patients (ie, anxiety about biopsy-associated pain/complications and tumor seeding), and lower health economic costs (cost of additional PSMA-PET vs cost of unnecessary biopsies), the researchers suggested,

My former urologist Scott Eggner, MD, and his UChicago colleague Parth Modi, MD, in an editorial in  European Urology, said about biopsy-free radical prostatectomy: “For many, the guttural response will understandably be shock and scorn. For us, the concept is discomfiting but provocative. After digestion of the data, the strategy has become more intriguing. While it remains surprising that any man would opt for prostatectomy to forego the potential morbidity of a biopsy, the authors affirm that the patients were counseled extensively and proceeded with appropriate informed consent.”

From a doctor’s POV, it seems strange not to obtain a confirmation of a tissue biopsy before performing radical surgery.  With the confirmation of the biopsy, urologists potentially can better counsel patients on their options between surgery and radiation. It probably seems strange to most veteran AS patients and maybe confusing to patients contemplating biopsies.

Meissner and colleagues apparently were jittery and uncertain about patients opting to proceed with radical surgery without biopsies. The researchers said: “We want to emphasize clearly that this practice should not be regarded as a standard procedure at the moment. Future studies with larger cohorts only inside a prospective, ethically approved study design are necessary to confirm these results.”

I can only wonder why these biopsy-shy patients didn’t consider the option of transperineal biopsy, which is more widely available in Europe than the U.S.

Modi and Eggener note that for the patients in the study the maximum potential benefit they might gain is relatively minor: “the avoidance of a prostate biopsy. In the modern era, this represents the avoidance of small risks of infection, hematuria [blood in the urine], urinary retention, and some discomfort. By contrast, the potential risks of proceeding with surgery include inadequate consideration of alternative management options, the risk of unnecessary surgery, and potential complications and side effects.”

The doctors refer to AS patients as a counterexample: “In this setting, we routinely recommend that patients undergo numerous prostate biopsies and additional blood and imaging tests to avoid, or merely delay radical treatment. Implicit in this recommendation is a value judgment that the downsides of one or several biopsies as part of a surveillance protocol are preferable to the downsides of potentially unnecessary upfront radical therapy for prostate cancer. It seems inconsistent to simultaneously advocate for patients to take on even a small risk of unnecessary surgery or have less than perfect information for treatment decision-making to simply avoid one prostate biopsy.”

It does seem ironic. But the reaction to biopsies in these German patients sends a powerful message to pre-diagnosed patients and AS patients on the biopsy train regarding biopsies. 

Would you consider a radical prostatectomy without having any kind of biopsy first?

Take TheActiveSurveillor.com Quick Survey: https://www.surveymonkey.com/r/3YBYK6T

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Please sign up for the program on the future of AS  22: "Your Voice in the Future of Active Surveillance,"  on April 22 at 11 a.m.Eastern/4 p.m. GMT. Register here: https://zoom.us/meeting/register/tJEtfuuqrzwtHNPuqzkigx65YBk8vV-teUdy

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