Breaking news: German study gives finger to Digital Rectal Exam

PSA, finding a niche in Europe?

By Howard Wolinsky

The Digital Rectal Exam (DRE) is taking its lumps and bumps again.

This time, a German study concluded that DREs might be useless in detecting early prostate cancers.

The DRE, also known as “The Finger Wave,” is an exam in which a urologist’s finger probes for unusual swelling or lumps in the rectum as an initial check for signs of prostate cancer.

In some countries, such as Germany, it is the sole method used in a national screening program for the disease, according to the European Association of Urologists.

(Chicago area cartoonist and AS patient Ira Lieb inaugurates his toon series with this issue of TheActiveSurveillor.com. Give a shout-out in the comments to Ira, and we’ll bring you more. Got any idea to name Ira’s prostate (character)?)

Researchers in the PROBASE trial, coordinated at the German Cancer Research Center (Deutsches Krebsforschungszentrum, DKFZ) in Heidelberg, suggest the technique may be missing many cancers in early stages.

The findings, presented on March 8 at the EAU Annual Congress in Milan, could have implications for the early detection of prostate cancer. Researchers are calling for other testing methods to be used in routine screening instead.

"One of the main reasons for screening for prostate cancer is to detect it in patients as early as possible as this can lead to better outcomes from treatment," said Dr. Agne Krilaviciute, a researcher at DKFZ and lead author of the study. "But our study suggests that the DRE is simply not sensitive enough to detect those early-stage cancers."

The PROBASE trial is a multicenter German prostate cancer screening study across four university sites (TU Munich, Hannover, Heidelberg, Düsseldorf) and involves 46,495 men aged 45 years who were enrolled between 2014 and 2019.

The men have since had follow-ups to assess their health in the years after the screening. Half of the participants in the trial were offered a prostate-specific antigen (PSA) blood test immediately at age 45 while the other half were initially offered DRE with delayed PSA screening at age 50.

(My urologist, Brian Helfand, MD, demonstrates his technique—Howard Wolinsky)

Ultimately, 6,537 men in the delayed screening group underwent DRE and only 57 of these men were referred for a follow-up biopsy due to suspicious findings. Only three were found to have cancer.

A whole lot of nothing except for three unlucky men.

(DALLE-E presents its AI view of an Andy Warhol-ish painting of a prostate.)

When compared to the detection rate using other methods, such as a PSA test, the rate of detection using DRE was substantially lower, says Krilaviciute.

"The DRE was giving a negative result in 99% of cases and even those that were deemed to be suspicious had a low detection rate," says Krilaviciute. "Results we've seen from the PROBASE trial show that PSA testing at the age of 45 detected four times more prostate cancers."

Researchers believe that changes in the prostate may be too difficult to detect in younger men. Plus, as we patients know well, some cancers are not readily reached with transrectal biopsies, let alone with a Finger Wave.

(Profesor Peter Albers)

"Early-stage cancer may not have the size and stiffness to be palpable," said Professor Peter Albers, a urologist at Düsseldorf University who was the senior author of the study. "Separate analysis that used MRI scans before biopsies to locate cancers in the prostate showed that about 80% of these are in an area that should be easy to reach with a finger and still cancers were not detectable by DRE."

The researchers are now calling for widespread use of PSA testing and MRI scans as part of screening programs instead of DRE—that is a new direction recently adopted in Europe.

Waving off DREs may have another advantage: Some men will be more willing to come in for a PSA blood exam than a rectal exam. Some men find the tests painful. Some are put off because they consider DREs homosexual acts.

"We speculate in our paper that not only is the DRE not useful for detecting cancer, but it may also be one reason why people don't come to screening visits—the examination probably puts a lot of men off. In Germany, for example, the participation rate is less than 20% in the screening program for men 45 to 50 years. If we were to offer PSA testing instead, more of them might be willing to come."

TheActiveSurveillor.com on Jan. 29 ran a report from a Movember consensus panel called for a ban of DREs: ”The use of DRE ranked lowest for both determining eligibility for and continuation on AS, due to its poor positive predictive value and impact on the patient. In fact, the use of DRE to initiate either additional tests (such as biopsy or MRI) or a treatment choice scored lowest among all tests, including PSA density, which is not commonly included in any of the guidelines.”

(Disclosure: I was a member of the panel.)

Also, TheAvtiveSurveillor.com reported last fall that European policymakers were getting on the PSA train by recommending that testing be available. In the past, in some countries, PSA was only available upon patient request.

Not everyone is prepared to wave goodbye to digital exams.

UCLA’s Leonard Marks, MD, told me: “Digital rectal exam should continue, in my opinion, not only for detection of the occasional prostate abnormality on palpation but also for detection of rectal lesions. Patients expect and appreciate the thoroughness of the exam. If not urologists, who will do this exam?”

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DRE revisited

By Howard Wolinsky

I took on Digital Rectal Exams in 2019 in my blog in MedPageToday “Digital Rectal Exams: Worth the Trouble?— Howard Wolinsky looks for the evidence, and doesn't find much”

The beginning of the blog:

Like most men, I'll never forget my first time.

I was 50-ish. On command, I dropped my drawers and bent over the examining table. I heard the snap of the gloves, and I felt some resistance as an index finger was inserted into my taut rectum for the dreaded digital rectal exam (DRE). I squirmed a little.

Next thing I knew, my family doctor was exploring my until-then-ignored, invisible-to-me prostate gland, looking for unusual bumps and textures. The rest is a blur.

The verdict? "It's small, but just wait," the doctor told me authoritatively.

As it happens, she was wrong. My prostate never got large. But "small" doesn't mean I escaped carefree. About seven years later, my prostate-specific antigen scan, not something to which I paid much attention, suddenly rose to nearly 4 ng/mL and a biopsy was performed, the first of several over the years since 2010. I had a near-microscopic cancer in a single core -- 1 mm long, with a low-risk Gleason 6. Seen once, never seen again.

…

(DALLE-E AI rendering of a stained glass image of a prostate gland.)

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ASPI premieres AS 101 segments on genetics and genomics

By Howard Wolinsky

Do you know the difference between genetic and genomic testing and how it can impact your decisions on whether to follow Active Surveillance protocols vs. more aggressive surgical and radiation options?

Yale researchers recently reported that although patients generally understood the purpose of genomic testing in identifying their risk status, many did not understand the difference between genomic testing and genetic testing.

ASPI is premiering a segment of the AS 101 series aimed at educating patients about the differences between genetic and genomic testing.

The program will be at 12 p.m. Eastern, Saturday, March 25. Click to register

AS 101, like an introductory college course, was launched in 2022 to explain in short video chats the basics of active surveillance for the newly diagnosed, those in the “gray zone” with rising PSAs but no biopsy confirming the presence of low-risk cancer, and also patients who have been on AS for a while but are looking for a refresher course.

Each session features prostate cancer patient, Larry White, and his well-informed wife, Nancy White, speaking with top experts about questions they have about AS issues in an office visit setting.

The Whites discuss genetics and genomics from a patient point of view with Justin Lorentz, MSc, a certified genetic counselor and lead of Sunnybrook Health Science Centre’s Male Oncology Research and Education (MORE) Program, a registry for men with hereditary cancer.  Lorentz, who is an instructor at the University of Toronto, is also a consultant to the Promise study, which offers free DNA testing to men with prostate cancer.

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The full series to date of AS 101 is available at: https://aspatients.org/a-s-101/

Episode 1. “Rising PSA,” featured Dr. Stephen Spann, a family doctor and founding dean of the University of Houston College of Medicine, who recommended that Larry who has a rising PSA blood level, and his wife Nancy, see a urologist

Episode 2. “The Urologist” focuses on the Whites’ first visit with a urologist, Dr. Laurence Klotz, of the University of Toronto, the father of active surveillance.

Episode 3. “Active Surveillance.” Dr. Klotz recommends Active Surveillance for Larry White.

Episodes 4 & 5, “Counseling Before DNA Testing,” and “Genetic Results.” The video focuses on Larry White’s inherited DNA to determine if he needs to take special steps.

Additional programs are coming with uropathologist Dr. Jonathan Epstein, of Johns Hopkins,  on biopsies and Dr. Andreas Correa, of Fox Chase Cancer Center, on imaging prostate cancer.

AS 101 is a project of the AS Coalition, which includes ASPI, the AS Virtual Support Group from AnCan, the Prostate Cancer Research Institute, Prostate Cancer Support Canada, and TheActiveSurveillor.com newsletter.

Special thanks to Alex and Peter Scholz and their team at PCRI who recorded and edited the program.