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 Source: AHRQ

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.

Role of Active Surveillance in the Management of Men With Localized Prostate Cancer

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