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“Very good news” for localized prostate cancer: ProtecT results

“Very good news” for localized prostate cancer: ProtecT results


MILAN — Men with Newly Diagnosed Localized Prostate Cancer Have Better Long-Term Outcomes Regardless of Their Initial Treatment Choice: Surgery, Radiation, or Active Monitoring I’m pretty sure it’s possible.

This is a welcome welcome from researchers in the large prostate cancer and Prostate Screening for Treatment (ProtecT) trial, in which more than 82,000 men were screened with the prostate-specific antigen (PSA) test between 1999 and 2009. This is a take-home message.

Of these screened men, 2664 were diagnosed with localized prostate cancer, and 1643 men in this group were randomized to undergo radical prostatectomy, radiation therapy, or active monitoring. assigned.

At a median follow-up of 15 years, there were no significant differences between the treatment groups in either prostate cancer mortality or all-cause mortality, the researchers report.

“Definitive treatment (prostatectomy or radiotherapy) halved the incidence of metastasis, local progression, and long-term androgen deprivation therapy compared with active monitoring. However, these reductions were , did not lead to differences in mortality at 15 years, which underscores the long natural history of the disease,” said the authors, led by Freddie C. Hamdy, MD, University of Oxford, UK. .

research is publish online March 11 New England Journal of Medicine Face-to-face and virtual, in line with data presentations at the European Urological Association (EAU) conference in Milan, Italy.

Peter Albers, MD, urologist at the University of Düsseldorf, Germany, and chairman of the EAU, said: Science Council Secretariat.

“Today’s active monitoring and biopsy protocols are much more advanced than when this trial was conducted, so we may be able to further improve these results. “It’s an important message to, especially if it means slowing down the side. It works, too.” “It’s also clear that we still don’t know enough about the biology of this disease to determine which cancers are the most aggressive, and further research on this is urgently needed. ”

Tightrope walking

Given the similarity of long-term survival outcomes irrespective of treatment assigned at baseline, treatment selection includes weighting

Hamdy et al. concluded the tradeoffs between benefits and harms associated with treating localized prostate cancer.

of Editorial accompanying the studyOliver Sarter, M.D., Ph.D., of Tulane School of Medicine in New Orleans, Louisiana, said the author’s recommendation for men and their clinicians to weigh the benefits and harms of treatment is “perhaps what treatment advocates want.” The length and scale of the trial would not have been reached.”

“The side effects of radical prostatectomy and radiation therapy are well documented, and many men have substantial sexual or urinary dysfunction after definitive local treatment,” he continued. “Today, as ever, there is a clear need for a less focused approach to the treatment of prostate cancer.”

In fact, researchers found that adverse effects of radiotherapy and surgery on sexual and urinary function persisted for up to 12 years.

But Sartor also noted that prostate cancer screening, diagnosis and management have evolved significantly since the ProtecT trial began in 1999.

For example, in the active monitoring group, if PSA levels increased by at least 50% over a 1-year period, or if there was any concern on the part of the patient or clinician, a review was triggered and the patient continued monitoring. increase. Or proceed to further testing and either radiation therapy, radical prostatectomy, or palliative care.

“Active monitoring, such as that performed in the ProtecT trial, should not be used at present. The increased metastasis rate may be reduced by an active surveillance protocol. It’s what’s being used today,” Sartor said.

The study results also revealed deficiencies in staging, he added, adding, “The majority of study patients were at low risk or good intermediate risk and would be considered suitable candidates for active surveillance today. ” he pointed out.

Protect details

The study enrolled 1643 men with a diagnosis of localized prostate cancer and a life expectancy >10 years who underwent active monitoring (545 patients), radical prostatectomy (553), or They were randomly assigned to receive either external beam radiotherapy (545 patients).

Patients assigned to radiotherapy received neoadjuvant androgen deprivation therapy (ADT) for 3–6 months, and patients assigned to surgery had positive surgical margins, extracapsular disease, or postoperative PSA levels of 0.2 ng. /mL or higher were offered an option. of adjuvant or salvage radiation therapy.

Strikingly, 1610 (98%) of all enrolled and randomized patients completed follow-up.

A total of 45 men died of prostate cancer. Prostate cancer mortality by treatment type was 3.1% for active monitoring, 2.2% for prostatectomy, and 2.9% for radiotherapy (P. = .53). All-cause mortality was 16.2, 15.0, and 15.0 per 1000 person-years, respectively, and did not differ significantly between treatment groups.

Men assigned to active monitoring developed significantly more metastases, compared with 4.7% (hazard ratio (HR), 0.47) assigned to prostatectomy and 5% (HR, 0.48) assigned to radiation. It was 9.4% in comparison.

More men (12.7%) were initiated on long-term ADT compared with 7.2% for prostatectomy and 7.7% for radiation, who were assigned to active monitoring. The HR for his ADT use compared with active monitoring was 0.54 in both the surgery and radiation groups, and these differences were statistically significant.

In addition, men undergoing active monitoring were more likely than men undergoing treatment to experience clinical progression (evidence of metastatic disease, initiation of long-term ADT, diagnosis of clinical T3 or T4 disease, ureteral obstruction, rectal fistula). , or urinary catheterization due to tumor growth). Surgery (HR, 0.36) or radiation (HR, 0.35).

However, the researchers found that these significant differences in disease progression in the actively monitored group compared with the other two groups that underwent surgery or radiation therapy did not translate into differences in overall survival. I am emphasizing that

Overall, the results suggest that “men with newly diagnosed localized prostate cancer and their clinicians should carefully consider trade-offs between harms and benefits of treatment when making management decisions.” It is possible to spend time on

The ProtecT trial was sponsored by the University of Oxford and supported by the National Institutes of Health and Medical Research (NIHR) Health Technology Assessment Programme. Hamdy reports being editor-in-chief of BJU International and a consultant to Intuitive Surgical UK. Most co-authors have no disclosures. A full list can be found in the original article. Sarter is a consultant to numerous pharmaceutical companies.

European Urological Association Annual Meeting (EAU 2023). Presented in an oral session on March 12, 2023.

N Engl J Med. Published online on March 11, 2023. overview, editorial

Award-winning medical journalist Neil Osterweil has been a frequent contributor to Medscape for many years.

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