Early results from a long-term study of prostate cancer patients concluded that removal of the gland barely increased the likelihood for survival in patients with low-risk tumors, concluding that the surgical approach "may be neither necessary nor effective."
The study, presented at the European Assn. of Urology meeting late last month, followed more than 730 men for an average of 10 years, concluding that low-risk patients who underwent radical prostatectomy were about 3% more likely to survive than men under the "wait and see" arm of the trial, regardless of age, race, comorbidity, health status or histology.
Patients with more serious tumors, based on prostate-specific antigen testing, were better candidates for surgery, according to the study’s authors.
The news comes amid an increasingly competitive market for prostate cancer treatment providers, in which robot-assisted radical prostatectomy is favored and Intuitive Surgical (NSDQ:ISRG) has a corner on the market.
A recently released meta-analysis looking at a clutch of studies with Intuitive’s da Vinci device found that the robot-assisted prostatectomy system was at least as good as other surgical methods in the short-term and may decrease complications related to surgery, MedScape.com reported.
Rival device maker Accuray (NSDQ:ARAY) last week announced the launch of a head-to-head clinical trial comparing its CyberKnife radiosurgery prostate cancer treatment device against Intuitive’s da Vinci robot. Neither study had the "wait and see" approach on the docket.
The newly presented research, sponsored by the U.S. Dept. of Veterans Affairs, set out in 1994 to compare radical prostatectomy with "watchful waiting," defined as "expectant management with palliative therapy for symptomatic or metastatic disease progression."
Led by Minneapolis Veterans Affairs Medical Center’s Dr. Timothy Wilt, the study looked at total mortality, disease free and progression free survival, morbidity, quality of life, and cost effectiveness for the 2 approaches.
Between 1994 and 2002 investigators enrolled 731 men averaging 67 years old into the Prostate Intervention Versus Observation Trial, randomizing patients for either surgery or watchful waiting, following up through 2010.
By the end of the study, 49.9% of the men assigned to observation and 47% of those assigned to surgery died. Among the observation group, 8.4% died from prostate cancer or prostate cancer treatment, compared with 5.8% of the prostatectomy group.
"Radical prostatectomy provides potentially curative removal of the cancer," the study concluded. "However, it subjects patients to the morbidity and mortality of the surgery and may be neither necessary nor effective."
One U.K. urologist wasn’t surprised by the findings, telling the U.K. Independent that many of the men included in the U.S. study shouldn’t have been considered candidates for prostatectomy to begin with based on their age and risk profile.
"We would offer milder treatment such as radiotherapy or watchful waiting," Guys & St. Thomas’ NHS Trust consultant urologist Ben Challacombe told the paper. "We are better than the U.S. in putting men on surveillance."
The researchers have been making the rounds, presenting their data at a variety of conferences without publication since last year. Some have raised eyebrows about the study’s lack of publication.
"It is becoming embarrassing that the full data from the PIVOT trial are still unpublished nearly 12 months after their initial presentation," editors at The “New” Prostate Cancer InfoLink wrote. "The PIVOT trial is an important study, but the Devil is in the details … and as yet the details from this trial remain unpublished."
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