Gothenburg PSA Study

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The Gothenburg study involved men 50 to 64 years at baseline; 9950 men were randomized to an organized 2-year PSA screening program, and 9949, who were not invited to formal screening but could have been screened on their own, served as the control group.

The screening was offered to the upper age limit of 69 years. Men in the screening group who had PSA levels of at least 2.5 ng/mL were offered further investigation, including a biopsy. The 18-year follow-up data show improved detection in the screened group. The overall prostate cancer incidence was 9.7 per 1000 person-years in the screened group and 6.5 per 1000 person-years in the control group (hazard ratio [HR], 4.5). As expected, prostate cancer mortality was also lower in the screened group than in the control group (0.51 vs 0.79 per 1000 person-years; HR, 0.65), said Dr Hugosson.

Subgroup analyses of the data also showed that men with less education derived more benefit from screening than those with more education, he added. Although prostate cancer mortality was lower in the screened group than in the control group, the benefit was more pronounced in those with lower education levels (rate ratio [RR], 0.49) than in those with medium–high education levels (RR, 0.76).

“In general, men with higher education have much more access to PSA testing, compared with less-educated men. But if you have a formal screening program, you diminish these differences; they have the same access to testing,” said Dr Hugosson. He added that “organized screening has the potential to diminish socioeconomic inequalities in prostate cancer mortality.”

Asked by Medscape Medical News to comment on the findings, Deepansh Dalela, MD, from the Henry Ford Hospital in Detroit, said that the Gothenburg study clearly shows that PSA screening is associated with decreased prostate cancer mortality. On the flipside, Dr Dalela recently showed that cutting back on screening results is increasing cases of advanced disease.

But too much screening should also be avoided, he said. “Our results also show that decreasing PSA screening did have a beneficial impact by reducing the likelihood of a diagnosis of low-risk prostate cancer in older men, which most urologists agree is fairly indolent and does not require treatment,” he noted. Dr Dalela also noted that the Gothenburg screening parameters, which are stricter than they have traditionally been in the United States, likely pick up more low-risk disease. He pointed out that “the threshold for performing a prostate biopsy in the Gothenburg study was 2.5 ng/mL, and the common threshold for biopsy in the United States is 4.0 ng/mL.”

Reference: European Association of Urology (EAU) 2016 Congress: Abstract 87. Presented March 12, 2016.

For Further Information
More on the markets for urology devices can be found in this latest edition report published by iData entitled U.S. Market for Urological Devices, which covers the U.S. as a whole, as well as market segments for urinary incontinence devices, stone management devices, BPH treatment devices, urological endoscopes, prostate cancer treatment devices, urodynamic equipment, and nephrostomy devices.

The iData series on the market for urological devices also covers the U.S., India, China, Japan, and 15 countries in Europe. Full reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. Register online or email us at [email protected] for an U.S. Market for Urological Devices report brochure and synopsis.

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