A digital rectal exam (DRE) is neither useful nor useful as a sole prostate cancer screening tool in middle-aged men, said the researchers reporting the PROBASE study.
This study compared risk-based screening strategies for men with prostate-specific antigen (PSA) measurements at age 45 years and men with PSA and DRE measurements at age 50 years.
Results show that as a sole screening tool, 99% of DREs did not raise suspicion of prostate cancer, and of the 57 cases in which DRE did raise suspicion, only 3 men had cancer. were found, all of which were low-grade. His Dr. Agne Krilaviciute and his colleagues at the German Cancer Research Center in Heidelberg reported.
“We also see that PSA is four times more likely to detect cancer than DRE. About 18% of tumors are located in areas of the prostate that are undetectable by DRE,” she said. I made an oral presentation here. European Urological Association (EAU) Conference.
The researchers found that the majority of prostate cancers that occurred in this relatively young population were International Society of Urological Pathologists (ISUP) grade 1 (Gleason score 3+3=6) or grade 2 (Gleason 3+4=7). ). DRE yields a positive result in only about 12% of ISUP grade 1 or 2 cases, they said.
“We conclude that DRE as a single screening test does not lead to significant PCa. [prostate cancer] Detection rates among young men,” said Krilaviciute.
fall by the wayside
This study provides increasing evidence that DRE may not be particularly useful as a screening tool or when used in active surveillance of men for prostate cancer.
As recently reported To Medscape Medical Newsan international consensus panel found that DRE can be safely skipped for active surveillance when other more accurate and objective measures such as MRI and biomarkers are available.
A prostate cancer expert not involved in the PROBASE study said: Medscape Medical News When he was in medical school it would have been viewed as a serious lack of practice no You don’t have to run a DRE, but things have changed a lot in the last few years.
said Julio Pow-Sang, M.D., director of the Genitourinary Oncology Program at Moffitt Cancer Center in Tampa, Florida.
“Empirically, it’s very rare to find a positive rectal test in this era of PSA,” he said, noting that the test itself is highly subjective and depends on the skill of a particular examiner. He added that the results were different.
“With such good research, I think digital rectal exams specifically for prostate cancer will gradually disappear,” Pow-Sang said.
Pro-based results
PROBASE, a randomized screening study enrolling 45-year-old men, tested a risk-adapted screening strategy using baseline PSA levels and DRE add-on offers in a large subcohort of participants .
The study was conducted in Germany, and the authors state that “Germany’s statutory early detection program recommends DRE as an independent screening test starting annually at age 45.”
PROBASE investigators enrolled 46,495 men from February 2014 to December 2019.
Of the 23,194 men initially enrolled, 6,537 had a DRE at enrollment without a trial PSA test.
In this group, 6480 DREs (99%) had no cancer suspicion and 57 (1%) had cancer suspicion. Among patients with suspected prostate cancer, 37 underwent biopsy and 20 did not. Of those who had biopsies, only two of them were found to have prostate cancer. This corresponds to a DRE cancer detection rate of 0.03%.
After a median follow-up of 6.6 years, only 1 additional case of ISUP grade 2 prostate cancer was detected among 6,357 men with DRE at enrollment, with a prostate cancer detection rate of 0.05. % became.
The researchers also looked at men who suspected DRE findings at baseline. They assumed that at age 45 he should still have a DRE-detectable tumor 5 years later and that at age 50 he should be PSA-detectable. Only one patient had elevated PSA levels. A biopsy was then performed and the results were negative.
Of those who underwent biopsy on the basis of DRE, 16 had prostatitis, 14 had benign prostatic hyperplasia, 1 had high-grade prostatic intraepithelial neoplasia, 1 had atypical small acinar hyperplasia, Three had equivocal findings.
In total, researchers found 24 tumors in men screened for DRE. Of these, 3 occurred in men whose results were deemed questionable, and 21 occurred in men who underwent unsuspecting digital tests. All tumors were ISUP grade 1, 2, or 3 tumors.
Among 245 men with PSA levels ≥3 ng/mL who underwent biopsy of predominantly Prostate Imaging Reporting and Data System (PI-RADS) 3-5 tumors, approximately 82% had DRE findings at biopsy There was no room for doubt in the case of Said.
“We also used the MRI data to determine the percentage of tumors potentially detectable by DRE. We estimated that approximately 18% of tumors were in the upper prostate that were not detectable by DRE,” she said. Told. “Even after excluding these tumors, the detection rate of DRE in palpable tumors is still low.”
DRE worked well in high-grade tumors, but 80% of PROBASE participants’ tumors were ISUP grade 1 or 2, which would likely go undetected by DRE, she added.
“In Germany, screening recommendations still include annual DRE at age 45. The PROBASE trial is the first to assess the diagnostic performance of DRE at such a young age. 1% of men undergoing DRE have suspicious findings, and cancer is very unlikely to be among the 1% of suspicious findings,” she said.
This research was supported by Deutsche Krebshilfe (German Cancer Aid). Krilaviciute and Pow-Sang reported no relevant conflicts of interest.
European Urological Association Annual Meeting (EAU 2023). Abstract A0899. Announced March 9, 2023.
Award-winning medical journalist Neil Osterweil has been a frequent contributor to Medscape for many years.
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