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Clinical trials offer a chance to try experimental treatments and move the state of science forward. Here’s what patients need to know.

Trial Run: What You Need to Know About Clinical Trials in Canada

Now that it’s legal for both medicinal and recreational use in Canada, cannabis is widely available to patients with cancer. How much it can help them is largely undetermined.

Weeding Out Uncertainty

Cancer brain fog, or chemo brain, interferes with daily life for many patients. Help can take the form of mental or physical exercise.

Out of the Haze of Chemo Brain

Limited treatment to a specific area with focal therapy is an “emerging area for treatment for prostate cancer,” with the potential to reduce side effects and have a major impact on quality of life in patients with prostate cancer, an expert said. 

At the recent CURE® Educated Patient® Prostate Cancer Summit, Dr. Kara L. Watts, associate professor of urology at Montefiore Einstein in the Bronx, New York, discussed how focal therapy — particularly high-intensity focused ultrasound (HIFU) — can be used in the treatment of prostate cancer.

In particular, HIFU is a newer treatment option in this space for patients with prostate cancer, which involves the targeted delivery of ablative energy to a portion of the prostate with cancer. With this approach, care teams intend on causing cell death while minimizing harm by not treating the entire prostate, Watts explained.

“Rather than the traditional radiation to the entire prostate or radical prostatectomy to remove the entire prostate, focal therapy is really aimed at finding the prostate cancer with imaging, treating just that area, but not treating the rest of the prostate that doesn't have cancer, or has cancer that doesn't need to be treated right now.”

Focal therapy is considered organ-preserving therapy and is an approach often used for other cancer types, but Watts said the use of focal therapy in 

 has lagged for a while. She attributed this lag to the ability to find and localize prostate cancer and because prostate cancer can spread in different parts of the prostate.

“Now that we have really, really great technology with MRI and using guided biopsies to identify the cancers where they are, the world of focal therapy has really become a promising and a growing option for a lot of men,” Watts added.

The main goal of focal therapy is to preserve quality of life, as it aims to minimize side effects associated with whole-gland treatment like radiation or radical prostatectomy. The most common side effects associated with these two treatment options include difficulty with erections and urinary incontinence.

Watts discussed some real-world findings during her presentation regarding the prevalence of side effects after whole gland radiation or radical prostatectomy. For example, a study published in the journal 

 in 2021 found that after radical prostatectomy, 74% of patients reported that they were able to control their urine one year after the procedure, meaning that 26% of patients were having difficulty with urine control.

“This is a real concern for people and a real outcome that patients consider,” Watts said.

Regarding erectile dysfunction, in a study published in the journal 

 in 2020, researchers found that its occurrence ranged between 30% and 70% in patients with prostate cancer who underwent whole-gland treatment with radiation or surgery.

Patient regret of their treatment decision may also play a factor in prostate cancer. Watts noted that there are several published papers that assess patient-reported regret after undergoing radiation or radical prostatectomy for their treatment.

“What you find is with focal therapy, the goal really is striking a balance between controlling cancer in a way that is effective, but also preserving function and quality of life,” Watts added.

She explained that there are several options related to focal therapy modalities, including cryotherapy, which she said was essentially killing cancer cells by freezing. Irreversible electroporation, or IRE, is a needle-based therapy where needles are placed around the area that needs to be ablated through the perineum, and the needles deliver an electric current through a controlled setting to promote cell death.

With HIFU, Watts explained that this is a different application of ultrasound than what it is traditionally used for to see organs like the kidney, bladder or spleen, among others.

“It's an ultrasound probe that gets inserted into the bottom, similar to how we see the prostate during a biopsy, although this is a different type of probe,” Watts said. “And the way that I describe this to patients is … you have a magnifying glass with a leaf. If you take a magnifying glass and you hold it over a leaf on a sunny day. And it's very far away and not focused, nothing happens. But if you hold that magnifying glass the right angle and distance away from the leaf, it will burn a hole, because it is focusing, in a beam, those rays of sunlight into a very precise, pinpoint spot on the leaf to cause it to burn.”

Through this approach, which was approved by the Food and Drug Administration in 2015, the focused beams of 

 can heat the affected area to burn in a very controlled manner within the prostate.

The treatment involves an ultrasound probe to see the prostate, Watts explained, for which patients would receive an enema before the procedure so nothing impedes the ultrasound’s ability to deliver energy to the prostate. Patients are put under general anesthesia for this procedure, which is typically performed in a hospital operating room or ambulatory surgery center and takes approximately two to three hours. Patients are able to return home the same day, so HIFU does not require an overnight hospital admission.

After the procedure, patients often go home with a catheter for a few days, which depends on how much tissue is treated during the procedure.

“[The catheter is] usually in place for about three to five days to allow some swelling from the procedure to settle down,” Watts said. “It's very often just minimal or mild symptoms post-procedure.”

A week after the procedure, patients may undergo an MRI to see whether the affected area was treated completely. Patients are then monitored by repeating PSA and getting another MRI within the first year after the procedure.

“The timing may depend on who's doing the treatment,” Watts explained. “And most people doing this treatment will also do a follow-up biopsy, usually at about six or 12 months, to confirm that the area has been completely treated and there isn't anything else developing.”

Watts said that HIFU is often a treatment option for patients with localized prostate cancer without metastasis (no disease spread).

“It's typically best for a low volume of prostate cancer,” Watts added. “So, if you have a really large tumor, this is probably not the best option for that. It is given in both initial or primary treatment, so sort of as your first treatment. And it can also be given for certain cases of recurrence after radiation treatment. So men who have had a recurrence of prostate cancer in the prostate after prior radiation, you can potentially be treated with HIFU.”

The most common disease type treated with HIFU in the U.S. is intermediate-risk prostate cancer, Watts said.

Even with its advantages, HIFU does have some potential risks for side effects, Watts said. The risk for urinary incontinence is approximately 1%, and nearly 15% of patients reported erectile dysfunction after the procedure. There is also a low risk for the development of urethral strictures or fistulas. Watts also noted the potential need for retreatment, which is “the most important [risk] that I really counsel men on.” She noted that this can occur in 20% to 40% of patients in five years.

“What that can mean is, you could have a recurrence in the area that's treated, or you could have a new cancer develop in another part of the prostate,” Watts said. “One of the benefits of focal therapy, especially with HIFU, is typically, all options still remain open to you, should that be needed. But this is one of the reasons it's very important to continue to be monitored after, really, any form of focal therapy for prostate cancer.”

Several studies have analyzed outcomes after focal therapy in patients with prostate cancer. In one study comparing radical prostatectomy with focal therapy, Watts said that the rate of failure-free survival — or needing to progress onto additional treatment — was similar in both groups at up to seven years. Findings from another study demonstrated that at five years after treatment, approximately 83% of men with intermediate-risk disease did not need to progress onto additional treatment.

Watts urged patients to discuss this treatment option with their care teams, although it may not be suitable for every patient.

“This is not an option for every patient,” she said. “It's something to discuss with the urologist to find out if you may be a candidate, and that's the most important feature of this talk.”

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Focal therapy, particularly high intensity focused ultrasound (HIFU), is emerging as a promising treatment for prostate cancer, aiming to preserve organ function and quality of life by targeting only cancerous areas. This approach minimizes side effects like erectile dysfunction and urinary incontinence associated with whole-gland treatments. HIFU is suitable for localized, low-volume prostate cancer and can be used as primary or salvage therapy. Despite its benefits, there are risks such as potential retreatment needs, but it allows for other treatment options if necessary.

With approaches like high intensity focused ultrasound, patients with prostate cancer may experience lower rates of urinary incontinence and erectile dysfunction, an expert said. 

Conference

Tumor

Focal Therapy May Reduce Side Effects, Improve Quality of Life in Prostate Cancer

 may be able to potentially predict disease relapse for patients with breast cancer following surgery and chemotherapy, researchers have found.

Researchers showed, in study findings published in 

, that among 156 patients with primary breast cancer who were monitored for up to 12 years after surgery and adjuvant (postsurgical) chemotherapy, personalized Signatera tests were able to detect ctDNA prior to clinical or radiologic relapse among 30 of the 34, or 88.2%, of patients who relapsed.

Relapse was predicted up to 38 months in advance of occurrence, the findings showed. Furthermore, the presence of ctDNA was also associated with shorter relapse-free survival (the time a patient lives without any signs or symptoms of disease) and overall survival (the time a patient lives, regardless of disease status), researchers stated.

“Serial postoperative ctDNA analysis has strong prognostic value and allows for earlier detection of recurrence than by scans in many patients, while repeated negative tests can provide assurance to patients

” researchers concluded in the study. “This provides a potential window that could enable the design of trials to assess the impact of earlier therapeutic interventions, which may lead to improved clinical outcomes, particularly in the setting of more aggressive subtypes (i.e., [triple-negative breast cancer]).”

All four of the patients who had negative ctDNA tests prior to experiencing relapse had hormone receptor-positive (HR+) disease. But, on the other hand, five of the 122 patients who did not relapse, all of whom had HR+ disease, had occasional false positive tests.

“For patients with HR+ breast cancer, who remain at risk of relapse for many years, a negative test does not rule out the possibility of relapse, and for those where ctDNA is detected, a repeated Signatera test may be needed to confirm a positive test,” researchers wrote. “In particular, confirming ctDNA concentration increase in subsequent tests might be more informative. Earlier intervention opportunities may allow better and more timely treatment with switch of endocrine therapy, but properly controlled randomized studies will be needed to determine if this is the case.”

All told, researchers summarized, “our results suggest that ctDNA testing may add to existing recommendations for symptom assessments, physical examination and routine breast imaging as a means of monitoring patients with breast cancer after completion of definitive local therapy with or without adjuvant chemotherapy.”

All of the cells in the body secrete cell-free DNA into the circulatory system, and clinicians can check for ctDNA — the cell-free DNA released by cancer cells — via a blood draw known as a liquid biopsy, as Dr. Ben Ho Park, director of the Vanderbilt-Ingram Cancer Center in Nashville, explained to CURE® earlier this year.

“Rather than going after a solid tumor and putting a needle in there, you can just get a tube of blood and get some of that genetic information — recognizing I'm saying some, because you can't necessarily get all — and the other advantage is you can do serial blood draws fairly easily compared to serial tissue biopsies,” Park explained.

ctDNA Will Be ‘Part of a Precise Monitoring Program’ in Breast Cancer

CURE’s Educated Patient® Webinars: Breast Cancer Awareness Month Series

 to hear personal stories, gain practical advice, and connect with a supportive community impacted by breast cancer.

Circulating tumor DNA (ctDNA) has shown potential in predicting breast cancer relapse post-surgery and chemotherapy. In a study of 156 patients, ctDNA was detected in 88.2% of those who relapsed, predicting relapse up to 38 months in advance. The presence of ctDNA correlated with shorter relapse-free and overall survival. Serial ctDNA analysis offers earlier recurrence detection than scans, especially in aggressive subtypes like triple-negative breast cancer. However, for hormone receptor-positive patients, negative ctDNA tests don't rule out relapse, necessitating further confirmation through repeated testing.

For some patients with breast cancer, ctDNA may have the potential to predict disease relapse after they have undergone surgery and chemotherapy.

Circulating Tumor DNA May Predict Postsurgical Breast Cancer Relapse 

Not all chemotherapy is by infusion. There are also oral chemotherapies.

That is what my oncologist is having me do for the next two weeks.

We stopped the intravenous infusions, which gave me a break from that experience. There is an expression we commonly use in our casual conversations that goes something like “Take the bitter and the sweet,” or “That was a bitter pill to swallow.”

Well, I am here to tell you that I am taking a bitter chemotherapy pill! As soon as it touches my tongue, my face begins to cringe. There is also a misguiding assumption that we can taste certain things better in different places on our tongue, but that is untrue. We can taste everything on all parts of our tongue. There are five types of taste buds (bitter, sweet, sour, salty and savory) and mine are working just fine. However, that is not true for my spouse. He has metastatic prostate cancer and went through target-specific radiation and his taste buds have not recovered yet. I have learned that everyone reacts differently to changes in the taste buds with radiation therapy.

For some people, they can recover as quickly as two months but for others, it can take up to two years or more. Unfortunately, my spouse is one of the latter. He went to the local farmer’s market and purchased some fresh raspberry and peach homemade jam. When he got home, he realized he could not taste it. When I put some of the jam on my toast with butter the flavor was subtle but good. I could clearly taste the peach and raspberry flavor. He has been noticing this side effectmore and more as we eat fresh fruits and vegetables. It is frustrating when you like something and can’t taste it. So I try to empathize with him.

The bitter pill that I take has to be taken with food. There is no wonder about that issue. Normally I take this pill first thing in the morning.

So, I have been making my breakfast with cereal and fresh fruit. I am rotating each day with fresh strawberries, peaches and blueberries. Now, I fill my stomach with cereal and fruit and then take the bitter pill with a slice of peach or a strawberry. That makes it tolerable. But there are a few occasions when it slips on my tongue, and I can immediately taste the bitterness blasting through my mouth! I am learning to take the bitter and the sweet in my mouth and in my life! It is the only way that we can get through our trials and tribulations. We have to accept the good and the bad. We have to embrace the positive and the negative.

We have to accept the happy times and the sad times. The bottom line is we must embrace the life we have been given. All we can do is try to find the balance in our life and be as resilient as possible. We have to strive for a positive outcome in our treatment and put up with the bitter pill!

Oral chemotherapy offers an alternative to intravenous infusions, but it can present its own challenges, such as unpleasant taste. Taste alterations are common side effects of cancer treatments, with recovery times varying significantly among individuals. The narrative highlights the importance of resilience and finding balance amidst the challenges of cancer treatment. It emphasizes the need to accept both positive and negative experiences, striving for a positive outcome despite the difficulties. The story underscores the shared journey of patients and their loved ones in navigating cancer's complexities.

I’ve recently started on chemotherapy pills instead of infusions and the bitterness reminds me to accept not only the bitterness of the pill, but in life too.  

 My Bitter Chemotherapy Pills for Chronic Lymphocytic Leukemia 

When a man receives a diagnosis of prostate cancer, Dr. Charles Ryan has two immediate questions: Has it spread outside of the prostate and, if so, is it resistant to the hormonal therapy typically used to treat the disease?

“When we talk about a patient with a life-threatening form of prostate cancer, those
are typically patients who have both of those phenomena,” said Ryan, director of the Division of Hematology, Oncology and Transplantation at the Masonic Cancer Center of the University of Minnesota in Minneapolis. “The cancer spreads to the bone, and standard hormonal therapy stops being effective, so the cancer begins to grow despite the lowering of testosterone.”

While those cancers, known as castration-resistant or hormone-resistant, represent the most advanced stage of the disease, the good news is that there are numerous ways to treat such cases, Ryan told 

. “In fact,” he said, “the number of treatments for prostate cancer has really exploded in the last four or five years, and it’s actually going to get even bigger in the next few.”

CURE®: What kinds of therapies are available to treat prostate cancer that has spread?

: We can divide them into three or four categories. With hormonal therapy, the standard of care would be some form of ablation of the level of testosterone in the body (because testosterone fuels the cancer). We typically do this with injections that lower the level of testosterone by about 90%. The most commonly used drugs would be leuprolide (Lupron Depot), degarelix (Firmagon) and goserelin (Zoladex). 

On top of that, we have targeted hormonal therapies that block the effect of testosterone even when the first line of therapies has failed. And that’s where we have drugs like enzalutamide (Xtandi), abiraterone (Zytiga), apalutamide (Erleada) and darolutamide (Nubeqa).

Compared with some other cancers, we use relatively little chemotherapy, but we do have some very effective chemotherapies. Docetaxel can be used in advanced hormone-resistant disease or as an initial therapy for metastatic disease. And we have a drug called cabazitaxel, which is similar.

The new class of drugs that we’re using now is the PARP (poly-ADP ribose polymerase) inhibitors, which target the mechanism of DNA repair (making it harder for cancer cells to repair themselves when damaged; these are used in patients whose cancers are already deficient in this ability due to gene mutations). In addition, we have a cellular therapy called sipuleucel-T, which is used in castration-resistant, metastatic disease. Finally, we have a radioisotope called radium-223, which is used in disease that has spread to the bone, causing bone pain.

Do patients have trouble sticking with any Q of these regimens, and, if so, what kinds of problems can that cause?

Treatment adherence has to do with whether the prescribed medication actually gets into the patient. Adherence for injected drugs is, of course, high; if a patient shows up and has the drug injected, adherence is almost 100%. But with oral drugs, we can lose adherence for a number of reasons. One is that a patient could take a bottle of pills home, put it in his medicine cabinet and never take it. Or, it could be that a patient starts to take a medication and because he doesn’t feel so good, he stops taking it. We would want to hear about that, why he doesn’t feel well and whether we could reduce the dose or give him a treatment break. As oncologists, that’s our job.

But the reality is that all the research in the world that leads to the development of a new therapy isn’t effective if we don’t get it into the patient. So, it’s sort of a dialogue between the doctor and the patient about what can or cannot be administered and why. It may not be just one factor. 

Unfortunately, a problem in this country is that patients sometimes bear a lot of the cost of their medication, so not being able to pay would be one (reason) for a patient not adhering to the treatment regimen. And that is something that I, as a doctor, would want to hear about, because we can think about patient assistance programs if they exist in your area, or we can think about ways we can reduce the dose to allow us to effectively deliver the drug, but perhaps on a slightly more cost-effective schedule.

How do treatment side effects impact the quality of life for patients?

Prostate cancer management involves assessing metastasis and resistance to hormonal therapy. Advanced cases, often hormone-resistant, have seen a surge in treatment options, including hormonal therapies, chemotherapies, PARP inhibitors, and radioisotopes. Treatment adherence is crucial, with challenges arising from oral medication compliance and financial burdens. Side effects impact quality of life, but effective cancer control can improve it. Clinical trials focus on optimizing existing therapies and exploring new ones like PSMA-targeted treatments. Progress in personalized medicine is ongoing, with resources available for patient support and information.

A growing number of treatments are available to men whose prostate cancer has spread and become resistant to hormonal therapy.

Pippa Wysong

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