BETHESDA, MD — Many men are receiving curative therapy for prostate cancer who would be better served by more passive, observational treatment, according to a panel of experts convened by the NIH.
After examining the available research — much of which came from an unpublished study of VA patients — the panel suggested that the paradigm for prostate cancer needs to change, especially for patients whose cancers are shown to be low or intermediate risk.
Patricia Ganz, MD, panel chairperson and proffesor of medicine at the University of California
While many men will benefit from immediate surgery or radiation, many also would benefit from delaying treatment and adopting a “watchful waiting” approach, according to panel members.
The panel identified emerging consensus in the medical community on a definition for low-risk prostate cancer: a prostate-specific antigen (PSA) level less than 10 ng/mL and a Gleason score of 6 or less. Using this definition, the panel estimated that more than 100,000 men of the 240,000 diagnosed with prostate cancer in the United States each year would be candidates for active monitoring, rather than immediate treatment.
“The natural history of prostate cancer has changed over the last 30 years,” explained Patricia Ganz, MD, panel chairperson and professor of medicine at the University of California, Los Angeles, at a press briefing following the conference. “With screening, we now have many men being diagnosed with low-grade and low-stage prostate cancer.”
This early detection means that the cancers being discovered are not always serious enough to warrant surgery or radiation, Ganz said. However, the culture in the field still heavily favors curative treatment.
“When men are given a diagnosis of cancer, it is very difficult to decline the standard therapy for this disease, which would be surgery or radiation therapy,” Ganz said. “But data from studies suggests that a more conservative monitoring strategy may be equally effective for men in terms of positive outcomes.”
Asked if men with prostate cancer are being “oversold” on the benefits of surgery, Ganz admitted that there might be bias — unconscious or otherwise — on the part of specialists to push for the curative approach.
“If a patient presents to a urologist, a more conservative approach may be offered,” Ganz said. “But the way in which it’s presented, the order in which it’s presented or hidden communication that the physician makes to the patient indicates that the observational strategy is not preferred.”
A diagnosis of cancer sets off an emotional response in patients, causing them to seek the most active treatment regimen, which already makes them lean in the direction of radiation or surgery, Ganz added. “There are many, many cancers that we overtreat.”Low Risk Prostate Cancer Often Is Over Treated Cont.
Observation Better For Low-Risk Cancer
Protocols to manage active monitoring still vary widely, which hampers a full evaluation and comparison of research findings, the panel discovered. Also, there is a paucity of significant research comparing observation versus surgery or radiation.
The one major study was a collaborative effort by VA, NIH and the Agency for Healthcare Research and Quality (AHRQ). The prostate cancer intervention vs. observation (PIVOT) trial looked at 731 patients with prostate cancer, who were split nearly evenly between observation and radical prostatectomy (RP).
Over 10 years of follow-up, about 50% of the men died, with only about 7.1% of total study participants dying from prostate cancer. However, during that time, researchers were able to make several key observations.
“Surgery did not reduce all-cause mortality for patients with low-risk pathology (PSA values less than 10),” said Timothy Wilt, MD, core investigator for VA’s Center for Disease Outcomes Research, who presented the study’s findings to the panel. “The absolute risk difference favored observation. There were fewer deaths in the observation group than the surgery group.”
The results for patients with PSA values over 10 were reversed, with the risk difference favoring RP.
Radical Prostatectomy Versus Expectant Management
However, along with surgery comes the danger of complications. About 21% of patients who had surgery had complications, with one patient dying as a result. Those complications included incontinence, infection, bowel injury, myocardial infarction, sepsis and the need for additional surgery.
More research is needed across the entire spectrum of prostate cancer treatment, the panel stated.
Observation and watchful waiting is a relatively new concept,” Ganz said. “If you look at the available literature on selective institution cohort studies, there are only several thousand patients reported in the literature. This is with a disease that affects 240,000 a year.”
One question that remains unanswered is what happens to patients who began with observation and then later chose surgery. The PIVOT trial did not break down that cohort.
“Can you have your cake and eat it?” Ganz asked. “We don’t know.”
The field needs more registry-based cohort studies and robust longitudinal data that includes active monitoring of study participants to help solve these questions, Ganz said.
The panel also recommended key changes in disease terminology. Because of the very favorable prognosis of PSA-detected, low-risk prostate cancer, the panel recommended removing the term “cancer” from this condition because of the anxiety it produces.
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