By Howard Wolinsky
The safety of protocol-driven Active Surveillance of men with low-risk prostate cancer was endorsed in a major new study by Seattle researchers.
Nearly half of men with low-risk prostate cancer were free from progression or treatment one decade after diagnosis, researcher Lisa F. Newcomb, PhD, of Fred Hutchinson Cancer Center in Seattle, and co-authors reported in JAMA.
"Our study showed that using active surveillance that includes regular PSA exams and prostate biopsies is a safe and effective management strategy for favorable-risk prostate cancer," Newcomb said in a statement. "An important finding was that adverse outcomes such as recurrence or metastasis do not seem worse in people treated after several years of surveillance versus one year of surveillance, alleviating concern about losing a window of curability.
"We hope that this study encourages the national acceptance of active surveillance instead of immediate treatment for prostate cancer.”
That’s good news for AS patients following reports on the rapid progression of prostate cancer in famed medical scientist Francis Collins, MD, PhD, former head of the National Institutes of Health, who suddenly was rushed for a radical prostatectomy after secretly spending five years on AS at the National Cancer Institute, More:
AS pioneers decode famed researcher's PCa scare, declare Active Surveillance safe option
(Drs. Laurence Klotz (above) and Peter Carroll, AS pioneers, find NIH’s Collins an outlier.) By Howard Wolinsky Francis Collins, MD, PhD, is one of the most prominent physician-scientists in the world. He led the Human Genome Project to map human DNA and later served as director of the National Institutes of Health, one of the top research institutions in…
In the new study, 43% of more than 2,000 patients had biopsy-grade reclassification of their cancers, and 49% had treatment for prostate cancer 10 years after diagnosis. Patients who received treatment after confirmatory or subsequent surveillance biopsies had a low rate of recurrence and distant metastasis, suggesting that delayed treatment did not lead to worse outcomes versus earlier treatment.
In short: “In this multicenter cohort study that included 2155 individuals with a median follow-up time of 7.2 years, the 10-year incidence of upgrading at biopsy and definitive treatment were 43% and 49%, respectively. The 10-year incidence of metastasis or prostate cancer mortality were 1.4% and 0.1%, respectively. There was no significant difference in adverse outcomes in men treated within the first 2 years of surveillance vs later on.”
This was an observational study involving 10 North American centers that enrolled patients with favorable-risk prostate cancer from 2008 through 2022.
Patients came from Beth Israel Deaconess Medical Center, Eastern Virginia Medical Center, Emory University, Stanford University, University of British Columbia, University of California San Francisco, University of Michigan, University of Texas Health Sciences Center at San Antonio, University of Washington, and Veterans Affairs Puget Sound Health Care System
Protocol followed
Patients were followed up using a standardized protocol in which PSA was measured every 3 months before 2020 and every 6 months starting in 2020. Prostate biopsies were protocol-directed at 6 to 12 months after diagnosis, 2 years after diagnosis, and then every 2 years; biopsies within 12 months of the target date were considered compliant. Sequential biopsies are described as diagnostic, confirmatory (first surveillance), and subsequent surveillance. The cumulative incidence of having the confirmatory biopsy within 2 years of diagnosis was 88%, and 97% of participants had the confirmatory biopsy within 5 years
90% of research subjects had Gleason 6/Grade. Group 1 cancers and the median prostate-specific antigen was 5.2 ng/mL.
Newcomb said that the reasons for the relatively low uptake are “multifaceted, but include fear of undertreatment, where a window of cure is missed in cancers that initially appear indolent but exhibit aggressive features during the course of surveillance. Furthermore, current clinical guidelines provide minimal guidance for optimal surveillance regimens. To improve utilization of active surveillance, a better understanding of how to best balance avoiding overtreatment while preventing undertreatment is needed.”
About 60% of. men with low-risk prostate cancers go on Active Surveillance in the United States compared with 90^-plus uptake of AS in Sweden and the U.K. The state of Michigan beaks from the herd in the U.S. with a 90% uptake of AS.
60% sounds like a low level of participation. But when I was diagnosed almost 14 years ago, only 6-10% of us opted AS. It was a novel idea, but many patients and their doctors were concerned about the cancer suddenly progressing to dangerous levels—which really is rare. (See Collins story above.)
AS has been a hard sell because most of us were brought up to believe if we see cancer, we to need rid of it. STAT. Also, many urologists and radiation oncologists used to feel compelled to treat these lesions.
In the bad old days, we were diagnosed—and next stop was an OR.
But doctor attitudes are changing.
MRI and biomarker story
Newcomb and co-authors note that enrollment began before the introduction of multiparametric prostate MRI and biomarker tests beyond PSA and continued through the adoption phase of the diagnostic advances.
The study's current protocol requires MRI before biopsy, and about half of the cohort has undergone MRI. Continued early use of MRI might lead to further reductions in recurrence and metastasis, researchers said.
Meanwhile, a well-known critic called BS:
So it goes.
Total eclipse of the heart and prostate: ASPI seminar on June 22
By Howard Wolinsky
Kevin T. McVary, MD, FACS, is a professor of urology and director of the Center of Male Health Stritch School of Medicine, Stritch School of Medicine, Loyola University Medical Center in Maywood, Illinois, outside Chicago.
McVary is a rare researcher on the heart and prostate gland and related issues.
He will be speaking at an Active Surveillance Patients webinar on Saturday June 22, 2024 at noon Eastern. The program is entitled “Matters of the Heart—and the Prostate.”
Register here: https://zoom.us/meeting/register/tJ0rdeGtrDIpEtynJ_U3A1rpWYkiCOHRMagt
Your heart is related to your prostate on many level. Erectile dysfunction can predict a heart attack by years. Also, most of us who have prostate cancer will most likely die from heart disease, not prostate cancer…
More to come.
here's the rebuttal
https://x.com/VPrasadMDMPH/status/1796212840468238523
I like what Dr. Prasad wfites.
Medical Student,
MedStudent,
I like much of what Prasad writes. He is an advocate for patients and science.
But I wonder if Dr. Prasad's experience with Active Surveillance patients is limited because he is a medical oncologist. Maybe PSAs, hormone therspy and mote are a huge burden for more advanced cancers?
On the low-risk side, I am 76 and have had PSAs--or their cousin PHI tests--for at. least 20 years.
I got stuck on the AS train in 2010 with routinerPSA testing.
In itself, it's not a big deal to me. Otherds may feel different.
Clearly, it's a gateway test fhat led too many of us to unnecessay aggressive treatment and potentially serious side effects. The end results of PSAs--some lives saved and many mnen overdiagnosed and overtreated.
Back then, we had annual biopsies, maybe more often for some. Those are burdensome.
Plus, they had risks we were not really warned about.
What do you all think.
Howard