Month: February 2022

Research shows a promising new option for men who experience rising PSA after a radical prostatectomy.

Many men who undergo surgical treatment for prostate cancer (a radical prostatectomy) live out their lives without a recurrence of their disease. But 20% to 40% of them will experience a rise in prostate-specific antigen (PSA) levels within 10 years of the operation. PSA should be undetectable in blood if the prostate has been removed, so elevated levels signify that the cancer may have returned. Doctors call this a biochemical relapse, and ordinarily they treat it by giving radiation to the prostate bed, which is where the prostate resided before it was taken out. Referred to as pelvic bed radiation therapy, or PBRT, this sort of treatment often succeeds in bringing PSA back down to zero for years.

Now, a large study shows that PBRT is even more effective when combined with other treatments. The findings are a potential game-changer for men experiencing a biochemical relapse after radical prostatectomy.

Funded by the National Cancer Institute, the SPPORT phase 3 clinical trial was conducted at nearly 300 medical centers across the United States, Canada, and Israel. A total of 1,797 men were enrolled between 2008 and 2015, all with post-surgical PSA levels ranging between 1 and 2 nanograms per milliliter (ng/mL).

The subjects were randomly assigned in roughly equal numbers to one of three groups. The men in group 1 got PBRT by itself, while men in group 2 got PBRT combined with four to six months of androgen deprivation therapy, or ADT. (Also known as hormonal therapy, ADT blocks testosterone, a hormone, or androgen, that fuels growing prostate tumors.) The men in group 3 got PBRT, ADT, and also radiation to the pelvic lymph nodes, where prostate cancer typically goes first if it begins to spread. The investigators wanted to know which of these three strategies is most effective at keeping disease progression at bay.

Results, side effects, and what’s next

According to their results, the more intensive treatments led to better outcomes. Just over 70% of men in group 1 were still avoiding disease progression after five years, compared with 80.3% of men in group 2 and 87.4% of men in group 3. More specifically, 145 of the men in group 1 developed further PSA elevations during the follow-up period, compared with 104 men in group 2 and 83 men in group 3. Similar trends were observed with respect to how many men developed metastases, or cancer that becomes resistant to hormonal therapy after it begins to spread.

The more intensive treatments also had more short-term side effects, especially diarrhea. But differences in side effects between the three groups disappeared after three months.

The authors emphasized that longer follow-up is still needed to confirm whether adding ADT and pelvic node radiation to PBRT actually lengthens survival. Moreover, the study did not evaluate a newer therapeutic strategy for biochemical relapse, where doctors use novel imaging methods to find exceedingly small metastases throughout the body that they treat directly with radiation.

Dr. Marc Garnick, the Gorman Brothers Professor of Medicine at Harvard Medical School and Beth Israel Deaconess Medical Center, and editor of the Harvard Health Publishing Annual Report on Prostate Diseases, says it’s important for men to understand that any measurable amount of PSA after a radical prostatectomy is abnormal and requires further evaluation. “The time-honored normal PSA range of 0 to 4 ng/mL no longer applies when men have had their prostates surgically removed,” he says. “Evidence of further benefits from adding ADT and pelvic radiation during this study is significant. Whether this represents a new standard of care in biochemical relapse requires additional follow-up.”

About the Author

Charlie Schmidt, Editor, Harvard Medical School Annual Report on Prostate Diseases

Charlie Schmidt is an award-winning freelance science writer based in Portland, Maine. In addition to writing for Harvard Health Publishing, Charlie has written for Science magazine, the Journal of the National Cancer Institute, Environmental Health Perspectives, … See Full Bio View all posts by Charlie Schmidt

More than five million Americans use wheelchairs. Getting one repaired is hard.

Wheelchairs restore mobility to people who are unable to walk or have limited ability to do so. Over a lifetime, this may describe many of us due to changes in health, injuries, neurological conditions, or disabling conditions like arthritis. So, when wheelchair technology or parts quit working, a quick fix would seem essential, right?

I know this firsthand. Unable to walk from decades with multiple sclerosis, I keep small scooters on every floor of my 1911 home, which is further adapted for accessibility with stair lifts and ramps. One day when I turned on my second-floor scooter-type wheelchair, sparks arced from the tiller opening atop the steering column, followed by smoke and the acrid smell of burning electrical wires. It was late on a Friday afternoon. No emergency repair service exists for wheelchairs or scooters. Now what?

Wheelchair repair delays are far more than an annoyance

Wheelchairs allow millions of Americans with mobility disability to participate in daily activities and community life (note: automatic download). We know this improves physical and mental well-being and overall quality of life.

On that Friday, my only option was to have my husband bring my first-floor scooter to the second floor. There I stayed, awaiting repairs on the now-inoperable scooter while my husband brought my meals upstairs. Because I have used the same small assistive technology company for more than 20 years — and have the owner’s cell phone number — by midafternoon on Tuesday, I once again had functional scooters on both floors. My confinement had lasted only four days. I know I was lucky on many levels.

But what if I lived alone, didn’t have another operational scooter, or hadn’t been able to wait four days? And what about people experiencing far longer waits for help with an essential device? While the 1990 Americans with Disabilities Act (ADA) prohibits discriminatory policies and requires physical accessibility in public services and spaces, it says nothing about this issue.

How often do wheelchairs break down?

Ideally, a wheelchair should be safe, reliable, and match your activity goals and functional needs. It should provide strong postural support and seating that protects against pressure injuries. Depending on strength and endurance, you might wish to self-propel a manual wheelchair. Or you might need a mobility scooter or power wheelchair propelled by a battery-powered motor, one that might even have sip-and-puff operational assistance or a chin-operated trackball.

Regardless of complexity, however — from basic manual wheelchairs to sophisticated rehab power chairs — all wheelchairs can break down, leaving their users stranded. Factors like broken pavement, inadequate curb cuts or soft terrain, steep inclines and inclement weather, and poor wheelchair design pretty much guarantee this.

In one study of 591 wheelchair users with spinal cord injury, 64% reported needing at least one wheelchair repair in the past six months. Among users requiring just one repair, wheels and casters posed the most difficulties for manual wheelchairs (46%). Electrical systems (29%) and power/control systems (27%) caused most problems for power wheelchair users. Rates of wheelchair breakdowns have increased in recent years, and vary across wheelchair manufacturers.

Repairs are costly, in more than one way. A survey of 533 wheelchair users with spinal cord injury found:

• Out-of-pocket repair costs ranged from $50 to $620 (the median, or midpoint, cost was $150).
• Time spent experiencing adverse consequences from wheelchair breakdown before repair ranged from two to 17 days (five days was the median).
• Among those reporting adverse consequences, 27% were stranded inside their home, 12% were stuck in bed, and 9% were stranded outside their home.

Wheelchair repair delays are lengthening: Could right to repair laws help?

Lengthening repair delays (automatic download) that heighten risks to consumers’ physical and mental health have caused many wheelchair users across the US to voice their outrage. However, reducing repair wait times isn’t simple. Medicare moved to competitive bidding in 2011, causing most small vendors — like my assistive technology company — to leave the business.

The two behemoths owned by private equity firms that now dominate the marketplace focus on boosting profits and cutting costs. By reducing technician hours and parts inventories, restricting consumers’ access to parts and software passcodes, requiring pre-approvals from insurers for repairs, and other practices, these companies virtually ensure delayed repairs.

Furthermore, Medicare and other insurers do not pay for preventive maintenance such as tightening loose bolts and cleaning casters, allowing problems to go undetected until breakdowns occur. Training can allow some wheelchair users to perform preventive maintenance tasks, but such training programs are not widely available.

Trying to reduce repair delays, Colorado’s governor recently signed the first “right to repair” law in the US for power wheelchair users. Complex software programs control many functions of power wheelchairs, and by holding this software as trade secrets, the manufacturers and large vendors have forced consumers needing repairs to use their services.

Much like recent right to repair laws for cars, the Colorado law mandates that power wheelchair owners and independent repair shops have access to the embedded software tools, parts, and other resources required to diagnose, maintain, or repair power wheelchairs. Other states, such as Massachusetts, may follow. Power wheelchair users in Massachusetts are testifying at public hearings about their repair horror stories to motivate the legislature to act.

Given the complexities of the wheelchair industry, it’s not clear whether right to repair laws will shorten repair times for power wheelchairs. Additionally, this law does not address manual wheelchairs or scooters like mine. Clearly, much more remains to be done to ensure timely wheelchair repairs. As wheelchair use surges, with growing numbers of baby boomers with mobility disability wanting to remain active in their communities, solving the wheelchair repair crisis is increasingly urgent.

About the Author

Lisa I. Iezzoni, MD, MSc, Contributor

Lisa I. Iezzoni, MD, MSc, is a professor of medicine at Harvard Medical School, and is based at Massachusetts General Hospital in Boston. Dr. Iezzoni studies health care experiences of persons with disability. She is a … See Full Bio View all posts by Lisa I. Iezzoni, MD, MSc

Let’s face it: inflammation has a bad reputation. Much of it is well-deserved. After all, long-term inflammation contributes to chronic illnesses and deaths. If you just relied on headlines for health information, you might think that stamping out inflammation would eliminate cardiovascular disease, cancer, dementia, and perhaps aging itself. Unfortunately, that’s not true.

Still, our understanding of how chronic inflammation can impair health has expanded dramatically in recent years. And with this understanding come three common questions: Could I have inflammation without knowing it? How can I find out if I do? Are there tests for inflammation? Indeed, there are.

Testing for inflammation

A number of well-established tests to detect inflammation are commonly used in medical care. But it’s important to note these tests can’t distinguish between acute inflammation, which might develop with a cold, pneumonia, or an injury, and the more damaging chronic inflammation that may accompany diabetes, obesity, or an autoimmune disease, among other conditions. Understanding the difference between acute and chronic inflammation is important.

These are four of the most common tests for inflammation:

• Erythrocyte sedimentation rate (sed rate or ESR). This test measures how fast red blood cells settle to the bottom of a vertical tube of blood. When inflammation is present the red blood cells fall faster, as higher amounts of proteins in the blood make those cells clump together. While ranges vary by lab, a normal result is typically 20 mm/hr or less, while a value over 100 mm/hr is quite high.
• C-reactive protein (CRP). This protein made in the liver tends to rise when inflammation is present. A normal value is less than 3 mg/L. A value over 3 mg/L is often used to identify an increased risk of cardiovascular disease, but bodywide inflammation can make CRP rise to 100 mg/L or more.
• Ferritin. This is a blood protein that reflects the amount of iron stored in the body. It’s most often ordered to evaluate whether an anemic person is iron-deficient, in which case ferritin levels are low. Or, if there is too much iron in the body, ferritin levels may be high. But ferritin levels also rise when inflammation is present. Normal results vary by lab and tend to be a bit higher in men, but a typical normal range is 20 to 200 mcg/L.
• Fibrinogen. While this protein is most commonly measured to evaluate the status of the blood clotting system, its levels tend to rise when inflammation is present. A normal fibrinogen level is 200 to 400 mg/dL.

Are tests for inflammation useful?

In certain situations, tests to measure inflammation can be quite helpful.

• Diagnosing an inflammatory condition. One example of this is a rare condition called giant cell arteritis, in which the ESR is nearly always elevated. If symptoms such as new, severe headache and jaw pain suggest that a person may have this disease, an elevated ESR can increase the suspicion that the disease is present, while a normal ESR argues against this diagnosis.
• Monitoring an inflammatory condition. When someone has rheumatoid arthritis, for example, ESR or CRP (or both tests) help determine how active the disease is and how well treatment is working.

None of these tests is perfect. Sometimes false negative results occur when inflammation actually is present. False positive results may occur when abnormal test results suggest inflammation even when none is present.

Should you be routinely tested for inflammation?

Currently, tests of inflammation are not a part of routine medical care for all adults, and expert guidelines do not recommend them.

CRP testing to assess cardiac risk is encouraged to help decide whether preventive treatment is appropriate for some people (such as those with a risk of a heart attack that is intermediate — that is, neither high nor low). However, evidence suggests that CRP testing adds relatively little to assessment using standard risk factors, such as a history of hypertension, diabetes, smoking, high cholesterol, and positive family history of heart disease.

So far, only one group I know of recommends routine testing for inflammation for all without a specific reason: companies selling inflammation tests directly to consumers.

Inflammation may be silent — so why not test?

It’s true that chronic inflammation may not cause specific symptoms. But looking for evidence of inflammation through a blood test without any sense of why it might be there is much less helpful than having routine healthcare that screens for common causes of silent inflammation, including

• excess weight
• diabetes
• cardiovascular disease (including heart attacks and stroke)
• hepatitis C and other chronic infections
• autoimmune disease.

Standard medical evaluation for most of these conditions does not require testing for inflammation. And your medical team can recommend the right treatments if you do have one of these conditions.

The bottom line

Testing for inflammation has its place in medical evaluation and in monitoring certain health conditions, such as rheumatoid arthritis. But it’s not clearly helpful as a routine test for everyone. A better approach is to adopt healthy habits and get routine medical care that can identify and treat the conditions that contribute to harmful inflammation.

About the Author

Robert H. Shmerling, MD, Senior Faculty Editor, Harvard Health Publishing

Dr. Robert H. Shmerling is the former clinical chief of the division of rheumatology at Beth Israel Deaconess Medical Center (BIDMC), and is a current member of the corresponding faculty in medicine at Harvard Medical School. … See Full Bio View all posts by Robert H. Shmerling, MD