Is it safe to do active surveillance instead of invasive treatment of prostate cancer?

Is active surveillance as good as more invasive treatment for men with prostate cancer? For many men, it is, according to a new study which confirms similar results from the same study group five years ago.

In 2018, oncology doctors were excited by the publication of the 10-year outcomes of the PROTECT prostate cancer trial published in The New England Journal of Medicine. Now the same publication has published the 15-year results of the trial and it is still good news for many men with early prostate cancer who want to avoid harsh treatments and the side effects they can cause.

The PROTECT trial followed more than 1,600 men that were divided into three categories: one-third underwent active surveillance, one-third had surgery and one-third had radiation therapy. About 3 percent of study participants died during the trial.

“At the end of 15 years, there were, again, no differences between the three groups,” said radiation oncologist Ethan M. Glazener, MD, who practices at Cape Cod Hospital and Falmouth Hospital. “That’s great news. The PROTECT trial is one of the best pieces of evidence we have that supports active surveillance.”

Not for Everyone

It does come with some nuances and caveats, though, and active surveillance isn’t for every patient. It specifically applies to patients with early-stage, non-metastatic cancer that is isolated in the prostate. The patient’s risk category is also a factor. Prostate cancer is categorized as low risk, intermediate risk and high risk, Dr. Glazener said.

Then it is further stratified into more definitive categories: low risk and very low risk, favorable intermediate and unfavorable intermediate, and high risk and very high risk. The trial covered both low risk and favorable and unfavorable intermediate risk patients.

Active surveillance used to be called “watchful waiting,” but the term was updated to reflect what actually occurs. The word waiting implied that nothing was being done, but that isn’t what actually happens.

“Active surveillance is the active monitoring of the individual so that if their dynamic changes we would be aware of it,” Dr. Glazener said. “So, they end up getting a PSA at least once a year and biopsies once every two years typically. For the vast majority of individuals, it’s slow growing.” Dr. Glazener pointed out that in the PROTECT trial at the 10-year mark, about 50 percent of the patients did move on to active treatment. At 15 years, it was 75 percent. That means that for 25 percent of the patients, their cancer never progressed further.

“It’s not like if you sign up for active surveillance it means for 10 years, you’re not doing anything,” he said. “What we are doing with active surveillance is we’re signing you up for actively surveilling you with a purpose; the purpose being if we see progression, we’re going to act and we’re going to start you on therapy with either radiation or surgery.”

While active surveillance is a recommended guideline for earlier risk cancers, it is not the best treatment option for all low-risk cancer patients A lot depends on the patient himself. The patient has to be willing to do a fairly high amount of follow-up treatment to ensure the cancer isn’t growing, Dr. Glazener said. Also, some patients find the idea of living with cancer inside of them to be unbearably debilitating emotionally. Each patient is different and has different needs.

PSA Tests Are Important

Since prostate cancers tend to occur in the peripheral zone of the prostate gland, it can be completely asymptomatic, which is why Dr. Glazener recommends that men ask their primary care doctor about doing a PSA (prostate-specific antigen) test.

The American Cancer Society recommends the following guidelines for the test:

• Age 50 for men who are at average risk for prostate cancer and are expected to live at least an additional 10 years.
• Age 45 for men at high risk of developing prostate cancer, including black Americans and men who have a first-degree relative diagnosed younger than the age of 65.
• Age 40 for men with more than one first-degree relative who had prostate cancer at an early age.

“Typically, the way it works is either their primary care gets a PSA or the gentleman has urinary symptoms and is sent to see the urologist and the urologist gets the PSA and does the workup,” Dr. Glazener said. “Then when the urologist sees an elevated PSA, they biopsy and, if they find out that it’s cancer, they then make the referrals for them to come see us, in combination with their own discussion about surgery.”

Learn Your Treatment Options

Dr. Glazener recommends that patients visit the National Comprehensive Cancer Network and click on the “guidelines for patients” link. There they can find the national guidelines for the standards of care for every kind and stage of cancer. They can learn about all the tests they will need to have and what treatment options are for each risk group.

If the cancer is confined to the prostate but more regionally advanced or aggressive, then treatment by surgery, radiation or both is necessary. Side effects are similar for both surgery and radiation but you get them in different ways, Dr. Glazener said. Patients who undergo surgery will have immediate side effects that can include urinary incontinence and erectile dysfunction. They hopefully go on to recover from there.

With radiation, side effects are caused by inflammation which leads to bladder/bowel side effects that go away when the radiation energy dissipates and the inflammation subsides.

“Radiation is energy and we are trying to get energy into your body and there are two ways we can do it,” he said. “It can be done with an external beam. We have this large machine that generates X-rays and the X-rays are the delivery mechanism. Or I can take radioactive seeds that emit the energy themselves and put them in you. That’s another method called low-dose-rate (LDR) brachytherapy.”

Low-dose brachytherapy can be done as a treatment for low and favorable intermediate risk prostate cancer and it can be used as an augmentation for unfavorable intermediate or high-risk cancers. Some patients may also need to take medications to lower their testosterone since testosterone fuels the cancer’s growth.

So far, all of the discussion has been about non-metastatic prostate cancer, Dr. Glazener noted. If the cancer has metastasized beyond the local lymph nodes, it is incurable. But that isn’t an automatic death sentence. "Incurable is a terrible word to hear, but incurable is definitely not the same as untreatable,” Dr. Glazener said. “In fact, we have a lot of treatments available to extend life and in a majority of situations help a man not die from his prostate cancer.”