Historic Veterans’ Prostate Cancer Bill Passes in the House of Representatives

The House unanimously passed H.R. 6092, also called the Veterans’ Prostate Cancer Treatment and Research Act which is designed to establish a national clinical pathway for prostate cancer. This standardized system of care has been designed to enhance treatment and increase access to clinical trials via a registry for the most commonly diagnosed cancer in the Veterans Health Administration.

The prostate cancer rate for veterans is nearly double that of civilians. These service members have dedicated their lives to the American people and they deserve to receive the same high quality care any one of us would expect when faced with a diagnosis of prostate cancer. The House of Representatives has helped to ensure that the nearly half a million veterans facing prostate cancer are no longer subjected to the risks of an unorganized health system.
This effort was sponsored by Congressman Neal Dunn, M.D. who is a former urologist. No timetable has been set for when the Senate may vote on the measure, but it’s expected to move quickly through the Senate.

Tips For Prostate Cancer Survivors; Keep An Eye On Cancer

There are more than 3.6 million prostate cancer survivors in the United States. Thanks in part to reliable diagnostic tests and numerous treatment options, nearly 100 percent of men are still alive five years after a prostate cancer diagnosis, 98 percent are alive 10 years after diagnosis, and about 96 percent are alive 15 years after diagnosis.

Prostate cancer survivors need regular follow-up tests to determine whether their prostate cancer has recurred or progressed. According to experts at the National Comprehensive Cancer Network (NCCN), most prostate cancer survivors should have a prostate-specific antigen (PSA) test every six to 12 months for the first five years after active treatment ends, then annually thereafter. Also, a yearly digital rectal examination (DRE) is recommended for some men, although this exam is not as important as PSA testing.

Prostate cancer survivors also need to be checked regularly for any new cancers that may develop. As an example, men treated with radiation therapy, particularly external beam radiation therapy (EBRT), have a slightly higher risk of developing bladder cancer than those who had a radical prostatectomy. In addition, the risk of developing colon or rectal cancer may be slightly higher for these patients.

The American Cancer Society (ACS) recommends following cancer screening guidelines for higher risk individuals where they exist. If any new symptoms develop in prostate cancer survivors, such as blood in the urine or rectal bleeding, those patients need to report them to the doctor right away.

Coming To The Market Soon; An Improved Test For Prostate Cancer

Some health providers feel that the lack of testing for prostate cancer today could be considered as a public health crisis.

The Simple Test Game Changer

The Journal of Urology has recently announced that miR Scientific, a healthcare company founded for the purpose of transforming cancer management, has validated its breakthrough, standalone liquid biopsy urine test for prostate cancer.
The validation study suggests that miR’s Sentinel test may be a much-needed and much-anticipated game-changer for men, clinicians, and healthcare providers as it could possibly replace today’s uncomfortable and invasive needle biopsies with a straightforward urine sample.

The test could potentially reduce three quarters of the prostate biopsies currently conducted. It could also drastically improve the coverage ratio of men tested.

According to the new study, the test detects the presence of cancer as well as classifies its aggressiveness for ongoing monitoring with over 91% sensitivity and specificity. Results are returned in just 7 days. Based on a urine sample, the Sentinel test produces its results by isolating molecules called small-non-coding RNAs, which are produced at or near the first inception of a prostate tumor.

This test leverages a proprietary algorithm to analyze the combination of these molecules present in the urine, and this analysis results in the cancer diagnosis and classification by stage.

Tips On Prostate Cancer And Diet

Studies have shown that people who generally eat more vegetables lead a healthier lifestyle. They tend to exercise more regularly and keep their weight to a normal level.

All of these factors are associated with better prostate outcomes. But it’s important that men with a family history maintain vigilance no matter what their diet or exercise regime.

When it comes to prostate cancer, a general rule to follow is that heart-healthy is prostate healthy. Men who have factors that are healthier for their heart such as blood pressure, cholesterol and weight are ultimately helping their prostate as well.

And of course, good exercise and diet doesn’t just help with prostate cancer. It also helps men avoid many other serious health issues.

Risk For Prostate Cancer May Increase From Habits Brought On By COVID-19

In the United States one in nine men will be diagnosed with prostate cancer, according the American Cancer Society. Yet many men are putting off life-saving cancer screenings due to the ongoing COVID-19 pandemic.

Prostate cancer is far too common to ignore; however, some men are unwilling to get checked during the pandemic.

The method for testing for prostate cancer is simple: a conversation with your doctor and a blood draw. The initial prostate cancer screening is the prostate specific antigen (PSA) exam. It is not a physical exam. A doctor can include PSA test with any lab order for blood work.

How pandemic habits may contribute to increased risk

There is an important diet, fitness and wholeness component to prostate cancer that many men are unaware of. These factors all have a significant impact on health outcomes.

Since the pandemic there has been an increase of bad habits among patients who are coping with being shut in/much more inactive. These habits can contribute to an increased risk of prostate cancer.

Additional pandemic-based risk factors include:

– Men are putting off healthcare and ignoring health issues because of the pandemic even though testing continues to be crucial.
– Doctors are seeing a surge in weight gain/belly fat from patients because they are reporting lack of exercise and poor diet choices. Studies show if your belly circumference measures greater than 36 inches, you are at greater risk of prostate cancer.
– Smoking. As a coping mechanism, many men have started smoking or have upped their smoking because they are experiencing stress, boredom and loneliness during the pandemic. Many health professionals feel that smoking can dictate the level of prostate cancer a man will have and also affect their ability to fight it.

Important facts about prostate cancer

– Prostate cancer is one of the most common cancers in men, both in the U.S. and globally.
– Approximately 192,000 men in the U.S. will be diagnosed this year: 1 in 9 men. 1 in 6 African American men.
– All men are at risk, but the risk increases significantly as men age. Men from 55 to 70 should talk with their doctor about a PSA testing on a 1 to 2-year basis.

Risk factors and early screening

Some men are at a higher risk for prostate cancer at a significantly younger age; as early as 40 years old. Early prostate cancer screening including a PSA test has been suggested by some doctors for men ages 40-54 if they meet the following criteria:

– They are of African-American decent.
– They have a father, brother, son, uncle or grandfather who has had prostate cancer.

Researchers Develop an Accurate Urine Test for Prostate Cancer

It was recently announced that researchers at the Johns Hopkins Kimmel Cancer Center have developed a simple and noninvasive urine test for prostate cancer. This would represent a significant step forward in diagnosis. Researchers have made significant progress toward the development of a simple, noninvasive liquid biopsy test that detects prostate cancer from RNA and other specific metabolic chemicals in the urine. The researchers’ findings appear in the journal Scientific Reports. The investigators emphasize that currently this is a proof-of-principle study for the urine test, and it must be validated in additional, larger studies before it is ready for clinical use.

The researchers used RNA deep-sequencing and mass spectrometry to identify a previously unknown profile of RNAs and dietary byproducts, known as metabolites, among 126 patients and healthy, normal people. The cohort included 64 patients with prostate cancer, 31 with benign prostatic hyperplasia and prostatitis diseases, and 31 healthy people with none of these conditions. RNA alone was not sufficient to positively identify cancer, but the addition of a group of disease-specific metabolites provided separation of cancer from other diseases and healthy people.

“A simple and noninvasive urine test for prostate cancer would be a significant step forward in diagnosis. Tissue biopsies are invasive and notoriously difficult because they often miss cancer cells, and existing tests, such as PSA (prostate-specific antigen) elevation, are not very helpful in identifying cancer,” says Ranjan Perera, Ph.D., the study’s senior author. Perera is also the director of the Center for RNA Biology at Johns Hopkins All Children’s Hospital, a senior scientist at the Johns Hopkins All Children’s Cancer & Blood Disorders Institute and the Johns Hopkins All Children’s Institute for Fundamental Biomedical Research, and an associate professor of oncology at the Johns Hopkins University School of Medicine and Johns Hopkins Kimmel Cancer Center member.

“We discovered cancer-specific changes in urinary RNAs and metabolites that — if confirmed in a larger, separate group of patients — will allow us to develop a urinary test for prostate cancer in the future,” says Bongyong Lee, Ph.D., the study’s first author and a senior scientist at the Cancer & Blood Disorders Institute.

Bill introduced to help VA tackle prostate cancer

Recently, Congressman Neal Dunn, M.D. introduced the Veterans Prostate Cancer Treatment and Research Act. Prostate cancer is the number one cancer diagnosed in the Veterans Health Administration with over 489,000 veterans undergoing treatment.

This new bill will direct the Secretary of Veterans Affairs to establish a national clinical pathway for prostate cancer and a standardized system of care for the treatment of what is the most commonly diagnosed cancer in the veterans’ health system.

“After everything our veterans experience while serving, the last thing they should be faced with is yet another enemy – prostate cancer,” Dunn said. “The key to overcoming prostate cancer is early detection. Veterans deserve a system that streamlines the pathway from early detection to successful treatment. This bill is a solid first-step forward to save fellow veterans lives and defeat this deadly adversary.”

Along with Dr. Dunn, Congressman Joe Cunningham is the lead Democrat co-sponsor of the legislation.

“Prostate cancer is the most common cancer diagnosis among veterans, and more prevalent among African American veterans than anyone else – one of the many health disparities that African Americans face,” Cunningham said. “This bipartisan legislation will go a long way toward improving health care outcomes for our veterans by standardizing treatment options and expanding access to cutting-edge clinical trials.”

It has been shown that veterans who have been in contact with toxins, such as Agent Orange, are at higher risk for prostate cancer. The establishment of a clinical pathway will standardize treatment options and result in improved outcomes for these patients. This bill will also create a real-time registry to track patient progress and will allow patients greater access to cutting edge clinical trials.

“The AUA is proud to support this important piece of legislation, which we believe will standardize treatment options and result in improved outcomes for prostate cancer patients. The VHA – as a national system for healthcare delivery – is perfectly positioned to create this program,” said AUA President Dr. John H. Lynch.

Apalutamide is approved by FDA for metastatic castration-sensitive prostate cancer

In the fall of 2019, the Food and Drug Administration approved apalutamide (ERLEADA, Janssen Biotech, Inc) for patients with metastatic castration-sensitive prostate cancer (mCSPC). Apalutamide was initially approved in 2018 for patients with non-metastatic castration-resistant prostate cancer.

Efficacy was demonstrated in TITAN (NCT02489318), a randomized, double-blind, placebo-controlled, multi-center clinical trial enrolling 1,052 patients with mCSPC. Patients received either apalutamide 240 mg daily or placebo, orally. All patients received androgen deprivation therapy (ADT)—either concomitant gonadotropin-releasing hormone analog or prior bilateral orchiectomy. Patients with both high- and low-volume disease were enrolled in the study.

Statistically significant improvements in both major efficacy outcomes of overall survival (OS) and radiographic progression-free survival (rPFS) were demonstrated. At the time of a pre-specified interim analysis, the hazard ratio for OS was 0.67 (95% CI: 0.51, 0.89; p=0.0053); however, median OS was not reached in either arm. The hazard ratio for the rPFS improvement was 0.48 (95% CI: 0.39, 0.60; p<0.0001). The median rPFS was not reached for the apalutamide plus ADT arm, and was 22.1 months for the placebo plus ADT arm.

The most common adverse reactions (incidence ≥10%) for patients who received apalutamide were fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture.

The recommended dose of apalutamide is 240 mg (four 60 mg tablets) orally once daily, with or without food. Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.

Prostate cancer and the effects on male fertility

Despite the best efforts of surgeons and radiation oncologists, it is nearly impossible for a man to retain his ability to father children through sexual intercourse after initial treatment for prostate cancer.

During a prostatectomy, both the prostate and the nearby seminal vesicles are removed. The seminal vesicles are two small structures that lie at the base of the bladder. Together with the prostate, they provide semen that carries the sperm down the urethra and out the penis during ejaculation. The loss of semen following surgery makes ejaculation impossible, so the sperm cannot physically make it out of the body to reach the woman’s egg for fertilization.

With radiation therapy, fertility is nearly always impaired. Radiated prostate cells and seminal vesicles tend to produce semen that cannot transport the sperm well. In addition, the sperm, which is made and housed in the testicles, can be damaged, but this is seen far less frequently with more accurate dose planning.

Fertility Options After Treatment for Prostate Cancer

For men who wish to father children after treatment for prostate cancer, the best chance for fertility is sperm banking. Semen containing sperm is frozen in liquid nitrogen and, although the cells are technically still alive, all cellular activity ceases. After thawing, up to 50% of sperm will regenerate and can be used for artificial insemination.

As an alternative to banking sperm, extracting sperm directly from the testicles might be an option. After harvesting sperm from testicular tissue, a single microscopic sperm is injected into a single microscopic egg. If an embryo forms, it is implanted into the woman’s uterine wall and allowed to grow.
Although technical advances in assisted reproduction have dramatically improved the conception rates, the success rates for the two procedures combined—sperm extraction followed by injection of the sperm into the egg—is less than 50%.

Apalutamide approved by FDA for metastatic castration-sensitive prostate cancer

The FDA has approved a supplemental New Drug Application (sNDA) for apalutamide (Erleada) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).1

The sNDA was processed through the Real-Time Oncology Review Program after the application received a priority review designation when it was submitted in April 2019. Results of the phase III TITAN trial, which were presented at the 2019 ASCO Annual Meeting, were the basis for the sNDA.

“Prostate cancer is more difficult to treat once it spreads, and for patients with castration-sensitive disease, it is clear that androgen deprivation therapy [ADT] alone, is often not enough,” Kim Chi, MD, a medical oncologist at BC Cancer – Vancouver and principal investigator of the TITAN study, said in a statement. “Results from the TITAN study showed that, regardless of the extent of disease, patients with metastatic castration-sensitive prostate cancer have the potential to benefit from treatment with apalutamide in addition to ADT.”

The FDA has noted that the recommended dose for apalutamide is 240 mg or 4 tablets of 60 mg each, given orally once daily with or without food. Additionally, the agency recommends that patients also receive a gonadotropin-releasing hormone analog concurrently with apalutamide or should have received a bilateral orchiectomy.2

The international, randomized, double-blind phase III TITAN trial included 1052 patients with metastatic castration-sensitive prostate cancer across 260 sites, regardless of prior localized therapy, docetaxel treatment, or the extent of their disease. Patients were randomized 1:1 to receive either 240 mg oral apalutamide once daily plus ADT (n = 525) or placebo plus ADT (n = 527). Treatment was given until disease progression, unacceptable toxicity, or the end of treatment was reached.

Patients had a median age of 68 years and 62.7% had high-volume disease whereas the other 37.3% had low-volume disease. A total of 16.4% of patients had undergone a prostatectomy or had received radiotherapy for localized therapy. Previous docetaxel therapy was noted in 10.7% of patients.

The coprimary endpoints of the trial were radiographic progression-free survival (rPFS) and overall survival (OS).

Apalutamide with ADT demonstrated an improvement in OS compared with ADT alone, resulting in a 33% reduction in the risk of death (HR, 0.67; 95% CI, 0.51-0.89; P = .0053). The combination also demonstrated a 52% reduction in the risk of radiographic progression or death (HR, 0.48; 95% CI, 0.39-0.60; P <.0001).1

According to findings presented at the 2019 ASCO Annual Meeting and subsequently published in the New England Journal of Medicine, at 2 years, the rate of OS was 82.4% with apalutamide and ADT compared with 73.5% in the ADT and placebo group (HR, 0.67; 95% CI, 0.51-0.89; P = .005). The 2-year rate of rPFS was 68.2% with the combination versus 47.5% with ADT alone.3,4

Both the median times to prostate-specific antigen (PSA) progression (HR, 0.26; 95% CI, 0.21-0.32) and cytotoxic chemotherapy (HR, 0.39; 95% CI, 0.27-0.56; P <.001) were improved with the addition of apalutamide. In the combination arm, 68.4% of patients demonstrated significant PSA declines to undetectable levels compared with 28.7% in the ADT and placebo group.

Treatment with apalutamide and ADT also resulted in a 34% risk reduction in the median time to second PFS (HR, 0.66; 95% CI, 0.50-0.87).

Grade 3/4 adverse events (AEs) occurred in 42.2% of patients in the apalutamide arm compared with 40.8% in the control arm. Serious AEs occurred in 19.8% of patients versus 20.3% in the 2 arms, respectively. Discontinuations due to AEs occurred in 8% of the apalutamide arm compared with 5.3% in the group receiving ADT alone. There were 10 AE-related deaths in the apalutamide arm versus 16 in the placebo arm.

Grade ≥3 AEs of special interest included rash (6.3% in the apalutamide arm vs 0.6% in the ADT-alone arm), fatigue (1.5% vs 1.1%, respectively), fall (0.8% in each arm), fracture (1.3% vs 0.8%), and seizure (0.2% vs 0).

“Erleada has the potential to change how patients with prostate cancer are treated, regardless of the extent of the disease or prior docetaxel treatment history, by delaying disease progression and prolonging survival,” Margaret Yu, MD, vice president, prostate cancer disease area leader, Janssen Research & Development, LLC, said in a statement. “This milestone highlights Janssen’s commitment to improve the standard of care for patients with prostate cancer as we continue to develop innovative treatments across the disease continuum.”

Apalutamide previously received FDA approval in February 2018 for the treatment of patients with nonmetastatic castration-resistant prostate cancer.
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