More breaking news from EAU: ProtecT study offers some new angles on impotence, incontinence in Active Monitoring patients
Eyes wide open when newly diagnosed decide a path
By Howard Wolinsky
Men with prostate cancer don’t need to undergo a prostatectomy to experience incontinence or impotence, UK researchers from the ProtecT study group reported in the journal NEJM Evidence and also to the European Association of Urologists Congress last weekend in Milan.
ProtecT found that patients with localized prostate cancer reported similar levels of physical or mental health, anxiety, depression, and cancer-related quality of life at five and 10 years. A gradual decline over time in physical health in all groups was not seen for mental health.
Researchers said:
— “All urinary symptoms, including leakage, had “somewhat” or “a lot” of impact on quality of life among 7 to 11% in the active monitoring and prostatectomy groups compared with 5 to 7% in the radiotherapy group.”
“In year 7, 18% of participants in the prostatectomy group had erections firm enough for intercourse compared with 30% in the active monitoring and 27% in the radiotherapy groups.”
—Differences between the groups were also reflected in related quality-of-life measures. Moderate-to-severe impact was reported by 42% in the prostatectomy group, 37% in the active monitoring group and 30% in the radiotherapy group at year 7 Levels of impact remained relatively stable, even though sexual function continued to decline in all groups over time.”
—Although all groups converged to a similarly low level of potency by year 12 (13 to 17%), each group exhibited a different profile of decline. Sexual/erectile function was retained most and for the longest in the active monitoring group. Levels of sexual/erectile function were lower in the radiotherapy group and lowest in the prostatectomy group."
—“Although anxiety and depression fluctuated, they remained at similar levels throughout,” researchers said.
Some side effects experienced by patients, including impotence and urinary incontinence, may be a function of advancing age rather than active treatment.
The late Gerald Chodak, MD, the grandfather of AS, told me years ago that urologists too often do not measure sexual health before and after performing prostatectomies. So patients sometimes are left with the incorrect impression that the surgery solely was responsible for their failing sexuality and urinary problems rather than recognizing the potential effect of aging.
Jenny Donovan, PhD, FMedSci, of Population Health Sciences, Bristol Medical School, University of Bristol, said: “With 12 years of follow-up, in an exploratory analysis, 3% of participants in the active monitoring group who remained on active monitoring [an early version of Active Surveillance] throughout and did not receive a radical treatment had urinary leakage, defined as use of one or more pads per day, compared with 16% among those who had received a radical treatment.
“Similarly, erections firm enough for intercourse were reported by 23% of participants in the active monitoring group who remained on active monitoring throughout and did not receive a radical treatment compared with 14% among those who had received a radical treatment.”
On Saturday, the same research team from the ProtecT study group made international news when they reported that the 15-year survival rate for patients with low- and intermediate-risk prostate cancer were comparable in men who were on Active Monitoring (an early version of ACtive Surveillance) or they had been treated with radical surgery or radiation.
About 3% of each group died from prostate cancer, they reported in the New England Journal of Medicine and at EAU.
At the same time, the UK researchers, led by Donovan, in the United Kingdom, reported on quality of life for these men.
Donovan and colleagues said in NEJM Evidence: “Most men diagnosed with low- or intermediate-risk clinically localized prostate cancer can expect to live 15 years or longer after diagnosis. Robust evidence is therefore needed about the adverse effects of treatment modalities on sexual, urinary, and bowel function as well as the quality of life over the short, medium, and long term to inform decision-making. Providing accurate information about adverse effects of treatment is critical to avoid later regret about treatment decisions.”
These data potentially can help those newly diagnosed with localized prostate cancer by giving them a glimpse of the road ahead whatever direction they might choose.
(Headline from NEJM Evidence.)
1,643 participants filled out questionnaires at six months after diagnosis in 2001-2009 and annually after that. Eighty percent of patients continued to fill out questionnaires.
Of the 545 men in the active monitoring group, 46% had received active treatment, either prostatectomy or radiation five years after diagnosis.
Fifteen years in, the proportion of men who had gone on AM and had been treated grew to about 75%.
So active treatment is in the cards for most men on AM. In these cases, AM—and now AS—served as a strategy for delaying treatment.
My expectation, and I think that of many of us with very low-risk cancer, is that we would live our days out, never being treated. That doesn’t seem to be the reality. I suggest that there be more research on why dropout rates are high and determine if more can be done to retain men on AS for longer. For more on AS’s dirty little secret:
Progression of prostate cancer is not the only reason men drop out of AM or AS. Men may be motivated leave active management because of surveillance exhaustion from years of living with uncertainty, and they can experience “anxious surveillance” from the one-and-off emotional distress triggered by the AS routine and from waiting for the results from PSA testing, MRIs and biopsies. Psychcologists and physicians call this “PSA Anxiety.”
Researchers said that among the randomized groups over seven to 12 years, generic quality-of-life scores were similar. But declines were reported over time.
“Among those in the prostatectomy group, urinary leakage requiring pads occurred in 18 to 24% of patients over 7 to 12 years, compared with 9 to 11% in the active monitoring group and 3 to 8% in the radiotherapy group,” they said.
Erectile dysfunction was lower in the AM and radiation groups until year 12 when all men were in sexual decline. Father time can be an MF.
“In the prostatectomy group, 18% reported erections sufficient for intercourse at seven years, compared with 30% in the active monitoring and 27% in the radiotherapy groups; all converged to low levels of potency by year 12,” the ProtecT study group said.
“Nocturia (voiding at least twice per night) occurred in 34% in the prostatectomy group compared with 48% in the radiotherapy group and 47% in the active monitoring group at 12 years. Fecal leakage affected 12% in the radiotherapy group compared with 6% in the other groups by year 12. The active monitoring group experienced gradual age-related declines in sexual and urinary function, avoiding radical treatment effects unless they changed management.”
“Patients newly diagnosed with localized prostate cancer need to choose their initial treatment after weighing the risks of adverse effects of treatment against risks of cancer progression and low likelihood of dying of prostate cancer,” Donovan et al. said.
There definitely needs to be more study as to the precise reasons why AS is dropped at some point in time. In addition, further data should be gathered on the level of anxiety and depression in men on AS over a period of years to develop a trend line of whether or not certain events and time frames are evident in dropping off of AS.