Ideas for Healthy Living Post Prostate Cancer Treatment

Seeking emotional support and adopting a healthy diet are important.

The end of treatments for prostate cancer can be both a relief and anxiety-provoking time in a man’s life, as well as the lives of his caregivers and loved ones. While there is usually great relief that the treatments are complete, many men may be worried about whether the cancer is really gone. Which is why this a great time for men to focus on some well-deserved self-care. Regular check-ups with your doctor will be ongoing, but there are some things you can and should do for yourself.

They include:
-Seeking emotional support
-Adopting a healthy diet and exercise routine
-Restoring sexual health
-Embracing a new normal

Emotional Support

The cycle of prostate cancer treatments and the instructions and restrictions that can come with them is stressful for many men. While your friends and family will have your best interests at heart, it may be difficult for them to understand what you’re going through. Finding support is important. If you’re unable to openly talk with those who are close to you, you may want to seek out some like-minded people who understand firsthand what you have experienced.

There are in-person and online support groups that can help. If you find the idea of talking to a group of strangers a bit daunting, perhaps seek out some of your fellow treatment “buddies.” If there are men you bonded with during your treatment journey, consider reaching out and keeping in touch with them. Indeed, support may prove to be more important than just surviving prostate cancer treatment.

Diet and Exercise

Considering a celebratory feast with food and drink post-treatment? While these types of indulgences are OK in moderation, you want to land on a healthy routine with exercise and a balanced diet that you won’t hate as critical features.

Load up on fresh fruits and vegetables, whole grains and fewer refined foods. Adding in some regular exercise can make a big difference in your recovery timeline, as well as your mood. Some studies show a healthful diet and regular exercise after treatment can help prevent prostate cancer recurrence. Yes, even a walk around the block counts. Take the dog or your grandkids and enjoy the view. The small effort can have a majorly positive effect on your overall outlook on life.

Sexual Health

There may be a change in your sex life after prostate cancer treatment. Anything from being unable to achieve an erection to loss of desire entirely is common, and it’s also often temporary. Try to be patient and in not too great a hurry to get back to whatever “normal” was for you before treatment. The body needs time to recover and heal. If you reach a point where you’re concerned, talk to your doctor. There are plenty of treatments available.

Creams, pills, injections and, in severe cases, surgical implants are all options you can discuss with your doctor or health care provider. You should also talk openly with your partner. Couples therapy, individual therapy and group therapy are all options to consider. No man should be ashamed to make restoring his sexual health an essential part of his overall wellness focus after prostate cancer treatment.

A Different You

Your life will be undoubtedly different after a prostate cancer journey. From the symptoms and diagnosis to the treatments and life afterward, the “new normal” can be uncomfortable at first. But that doesn’t mean it’s all bad. While there’s no surefire way to prepare for life after prostate cancer, have confidence that you will find your way. You have gained wisdom and a perspective on life that may very well help another man who finds himself at the beginning of a prostate cancer journey.
Remember that emotional support is just as important as the medical treatments, and a healthy lifestyle afterward will help with physical and emotional recovery. Don’t be afraid to ask for help or guidance from your doctor, health care team and trusted loved ones and friends.

Immune Discovery Show Possibilities of ‘Treating all Cancers’

A newly-discovered part of our immune system could be harnessed to treat all cancers, say scientists.

The Cardiff University team discovered a method of killing prostate, breast, lung and other cancers in lab tests.

The findings, published in Nature Immunology have not been tested in patients, but the researchers say they have “enormous potential”.

Experts said that although the work was still at an early stage, it was very exciting.

What have they found?

Our immune system is our body’s natural defense against infection, but it also attacks cancerous cells.

The scientists were looking for “unconventional” and previously undiscovered ways the immune system naturally attacks tumors.

What they found was a T-cell inside people’s blood. This is an immune cell that can scan the body to assess whether there is a threat that needs to be eliminated.

The difference is this one could attack a wide range of cancers.

This raises the prospect of a ‘one-size-fits-all’ cancer treatment, a single type of T-cell that could be capable of destroying many different types of cancers across the population.

How does it work?

T-cells have “receptors” on their surface that allow them to “see” at a chemical level.

The Cardiff team discovered a T-cell and its receptor that could find and kill a wide range of cancerous cells in the lab including lung, skin, blood, colon, breast, bone, prostate, ovarian, kidney and cervical cancer cells.
Crucially, it left normal tissues untouched.

Exactly how it does this is still being explored.

This particular T-cell receptor interacts with a molecule called MR1, which is on the surface of every cell in the human body.

It is thought MR1 is flagging the distorted metabolism going on inside a cancerous cell to the immune system.

The researchers are the first to describe a T-cell that finds MR1 in cancer cells.

This finding is significant

T-cell cancer therapies already exist and the development of cancer immunotherapy has been one of the most exciting advances in the field.

The most famous example is CAR-T – a living drug made by genetically engineering a patient’s T-cells to seek out and destroy cancer.

CAR-T can have dramatic results that transform some patients from being terminally ill to being in complete remission.

However, the approach is highly specific and works in only a limited number of cancers where there is a clear target to train the T-cells to spot.

And it has struggled to have any success in “solid cancers” – those that form tumors rather than blood cancers such as leukemia.

The researchers say their T-cell receptor could lead to a “universal” cancer treatment.

With Equal Care, African American and White Men Have Same Prostate Cancer Survival

A new study suggests that when it comes to prostate cancer, African American men have similar survival rates to white counterparts if they have equal access to healthcare.

Research conducted in the past has found African Americans are twice as likely to die from prostate cancer as whites, and the reasons may include diagnosis when the disease is more advanced as well as differences in medical care.

However, this new study, which followed more than 60,000 men with prostate cancer getting care from the U.S. Veterans Administration Health System, found African American men did not have more advanced disease at diagnosis and did not die earlier than white men, researchers reported in Cancer.

“Throughout the U.S. population, African Americans usually have worse outcomes with prostate cancer,” said the study’s senior author Dr. Brent Rose of the University of California, San Diego. “The hypothesis has been that the disease is just biologically more aggressive in African American men.”

“Our study suggests that is not a foregone conclusion,” Rose said. “There’s something about the way the VA medical system reduces disparities seen in normal healthcare that suggests that equal outcomes could be created with smart policy decisions.”

These findings doesn’t mean there are no biological differences between blacks and whites when it comes to prostate cancer. African Americans are more likely to get prostate cancer than whites: one in eight versus one in twelve. And they tend to get it three to four years younger for reasons that are unknown.

The findings suggest that when African Americans get good access to care and prompt treatment, disparities in survival disappear.

To determine whether access to healthcare might play a role in the disparity in survival between blacks and whites, the researchers analyzed information on more than 20 million veterans who receive care through the San Diego VA’s healthcare system.

These researchers focused on 60,035 men diagnosed with prostate cancer between 2000 and 2015, 30.3% of whom were African American and 69.7% were non-Hispanic white. Fifty percent of the men were followed for nearly six years, and some were followed for as long as 10 years.

The overall results showed that there were 3,067 deaths from prostate cancer in the group, 848 among African American men and 2,219 in non-Hispanic white men.

The rate of prostate cancer death over a 10-year span among black men was slightly lower than the rate among whites: 4.4% versus 5.1%.

The new results are very good news, because when you find the cancer at the same stage you can have the same survival outcome. However many more African Americans still die from prostate cancer.

Researchers determined that they still need need to find a way to diagnose prostate cancer earlier in African American men in the general population.

Cancer death rates are going down. Is prostate cancer an exception?

Confusion about PSA screening may be a factor, experts say.

In a time of declining death rates from cancer, prostate cancer is something of an outlier.

The American Cancer Society last month reported a 2.2% decline in the cancer death rate in 2017, although it gave most of the credit to a drop in lung cancer deaths tied to a continued decline in smoking.

But a nonprofit called Zero — The End of Prostate Cancer, which focuses specifically on seeking an end to prostate cancer, discovered troubling news, also from American Cancer Society data. The report projects that in 2020, the number of men who die from prostate cancer in the U.S. will be at the highest level in two decades. It will represent a 5% increase in a single year, according to Zero’s news release.

“These statistics are unacceptable and show the urgency for men to get tested early, given the high likelihood of men developing prostate cancer during their lifetime,” said Zero CEO Jamie Bearse in the news release.
But two Minnesota cancer experts the News Tribune spoke with for this story took a more nuanced view.

“I don’t know that there’s some hidden epidemic of prostate cancer that we’re missing,” said Dr. Charles Ryan, an oncologist at the University of Minnesota Medical School for whom prostate cancer is a top research area.
The figures for 2020 are speculative, of course. “We don’t know the number,” Ryan said. “They’re still estimates, and we don’t have the actual number.”

Ryan said there are other factors to consider. Dr. Daniel Nikcevich, an Essentia Health oncologist who also is president of Duluth Clinic and was interviewed separately, agreed.

For one thing, Ryan said, a wave of baby boomers is entering their 70s, which is prime age for prostate cancer. Also, fewer people are dying of heart diseases in their 50s and 60s, which means more men are living to an age when prostate cancer is more of a risk.

Nikcevich and Ryan both pointed to changes in the use of prostate cancer screening as a factor. In 2012, the U.S. Preventive Services Task Force issued an advisory discouraging PSA screening. Falsely elevated readings sometimes led to unnecessary medical treatment and traumatized men, the task force found. In short, it concluded that PSA tests were doing more harm than good.

The task force has since walked back that recommendation, Ryan said, but it created enough confusion that many primary care physicians have stopped doing the screenings.

The problem is that more lethal forms of prostate cancer aren’t being detected as soon as they used to be, Nikcevich said. And that reduces the chances of successful treatment.

“The pendulum has swung the other way, where under-treatment has happened as the screening is not happening to the same extent it happened before,” he said. “And now men are coming to our attention with symptomatic advanced prostate cancer, and we would think if we had known about that two years ago, this would have been a different issue.”

There’s an excellent chance of curing any form of prostate cancer if it’s caught early, Nikcevich said.

A large study by Kaiser Permanente researchers in northern California found that for every 25 prostate cancer missed by lack of screening but found later, one was metastatic, meaning it had spread beyond the prostate. The study was published in December in the Journal of General Internal Medicine.

The Zero organization is bullish on PSA tests.

“Early detection saves lives, but unfortunately, decades of mixed messaging about the PSA test have left both doctors and men confused about the importance of testing,” Bearse said in the news release.
The conventional thinking, Ryan said, is that men should have a PSA screening beginning at age 50, but at age 40 if there’s a concerning family history or other reason to suspect a greater risk of prostate cancer. That should be a discussion between the patient and his doctor, he said.

Nikcevich emphasized the importance of that conversation about whether to screen or not to screen.

“And unfortunately, I think what’s happened too often is that it’s just not done, and that conversation doesn’t necessarily occur,” he said. “And there’s a variety of reasons for that, ranging from perhaps misinterpretation of the guidelines to patients not wanting to be screened to physicians not having time to do the screening.”

More benign forms of prostate cancer can be observed without necessarily requiring any form of treatment, Nikcevich said. When treatment is necessary, it has improved greatly in recent years. Both surgery and radiation treatment for prostate cancer have become far more precise, he said. Surgery is almost always done robotically now.

“And there’s far less discomfort and pain in that regard,and I believe quicker post-operative recoveries,” Nikcevich said.

If some form of treatment for your prostate cancer is recommended, ask if there are any clinical trials available, he advised.

If you’re in a clinical trial, you’ll receive the top current standard of care plus a new form of therapy that otherwise would be unobtainable, Nikcevich said. You’re also helping to pave the way on behalf of other cancer patients down the road.
Men who want to better protect themselves from prostate cancer should know their family history, discuss screening with their doctor and live a healthy lifestyle, Ryan said.

That includes exercise, eating more salmon and fatty fishes, using healthy oils such as olive oils and eating healthy nuts such as almonds. It also means cutting down on processed meats and well-cooked red meats. Even drinking coffee can provide some protection against prostate cancer, he said.

Men should be attuned to their bodies, Nikcevich said. Symptoms that could suggest a problem include a change in your ability to initiate a stream of urine, leakage of urine, pain with urination, blood in the urine and sometimes sexual dysfunction.
“These are not easy subjects for men to talk about,” he acknowledged.

So much so that the doctor often needs an ally.

“You see a guy in the office and ultimately, why is he there?” Nikcevich asked rhetorically. “He’s there because his wife told him he had to be there, and he’s sick of hearing about it.”

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.

Two men share their personal stories about how cost-free prostate cancer screenings save lives

We are both men who have been diagnosed with prostate cancer. Our journeys to diagnosis were different: One of us was a firm believer in screening due to a family history of the disease, and the other was reluctant and uninformed.

However, after our individual diagnoses, we both became passionate advocates for early detection. We were both devastated but determined to fight our own battle while making other men aware of their own risks.

As Maryland residents, we were excited to learn about legislation from Del. Erek Barron and Sen. Malcolm Augustine that would help increase access and affordability for prostate cancer screenings. Finally, men aged 40-75 who, according to population data from 2018 account for almost half of Maryland’s men, will have the chance to beat the disease before it beats them.

In 2019, Maryland had the eighth highest prostate cancer incidence rate in the country. Now, in 2020, prostate cancer will be the most diagnosed cancer among men in Maryland — so much so that it’ll be diagnosed at a rate nearly double of the next most prevalent cancer for men in the state (lung and bronchus). With this legislation, Maryland can make history by becoming the second state in the nation committed to protecting the rights and wallets of prostate cancer patients. Like many medical tests, medical costs and fees can add up. No patient should be deterred from receiving a lifesaving test due to cost or unanticipated fees.

The newly introduced legislation from Delegate Barron and Senator Augustine removes all cost-sharing fees (co-pays, etc.) associated with prostate cancer screening tests — both the digital rectal exam (DRE) and the prostate-specific antigen test (PSA). Both tests are proven to detect cancer in the prostate gland and help inform treatment plans if cancer is indeed detected.

By making prostate cancer screening cost-free, the disease would finally have parity with breast cancer screenings (mammograms) and ovarian cancer screenings (pap smear). Both diseases have screenings that infer no cost-sharing fees and, further, are genetically linked to prostate cancer. Additionally, prostate cancer and breast cancer have similar incidence rates — both impacting about nearly 15 percent of the national population.

Prostate cancer often presents without symptoms making regular screening imperative to a man’s chance of survival. If caught early, the disease has a nearly 100% chance of survival. Alternatively, if the cancer is detected too late, the chance of survival drastically drops to only 30%. Removing barriers to prostate cancer screening and diagnosing prostate cancer at an earlier stage is much more cost-effective than treating late-stage prostate cancer.

It’s especially important to make screening for this awful disease accessible and affordable since prostate cancer deaths are on the rise. New reporting from the American Cancer Society shows that in 2020, the number of men who will die from prostate cancer will hit a record high over the last two decades with an increase of 5% since just last year. By making prostate cancer screening accessible and affordable, more Maryland men can have their lives saved from cancer.

Today, we both feel grateful, lucky and blessed. If it wasn’t for a prostate cancer screening, we wouldn’t be here today. It’s up to us, patients and survivors, to help save the lives of other men and make them aware of their disease risk. One way to do that is through this powerful new legislation, which has the power to save lives. Without cost-sharing fees attached to screening, more men can access prostate cancer screening without barriers. This means more lives saved, more families kept intact and more proof of the power of early detection and advocacy.

Written by Robert Ginyard and Phil Shulka, Baltimore
The writers are, respectively, chairman of the board of ZERO – The End of Prostate Cancer, and a volunteer and mentor to men recently diagnosed with prostate cancer with that organization.

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.

Air Force will have answer on pilot cancers next year, study goes on despite COVID-19

The United States Air Force has finalized the terms of a groundbreaking study sought by former fighter pilots in order to determine whether military aviators are more likely to be diagnosed with cancer.

Retired Air Force fighter pilots have pressed the service for more than a year to look at the number of aviators who have either died from, or are fighting various types of cancers, and to look for potential causes.

Late in 2019 the Air Force announced that it would conduct a first-of-its-kind study of all cancers among its former pilots, a review that may be replicated by the Navy for its aviators depending on what the results reveal.

In newly-released details, the Air Force said it had finalized the design for the study and was committed to reviewing all of its pilots dating back to 1970, which would capture medical histories of pilots who flew earlier versions of military jets that carried more powerful radars in the cockpits.

Many of the pilots have suspected that cockpit radiation generated by those radars may be linked to their cancers.

The new study will also compare former pilots’ cancer rates to cancer rates among the general population. Other previous military cancer studies had focused on internal comparisons between active duty personnel, such as comparing active duty ground crew to active duty pilots. Those studies had not found higher rates.

In October in an exclusive investigation, “Stricken” it was reported that the rates of treatment at VA health care centers for many types of cancers rose sharply over the last two decades of war. When researchers looked across all services, treatment rates for urinary cancers — which include bladder, ureter and kidney cancers — have jumped 61 percent from fiscal year 2000 to 2018. Along with those findings, prostate cancer treatment rates have risen 23 percent. The Marine Corps recorded the sharpest increase, with a 98 percent jump in urinary cancer treatments.

An earlier investigation found that since fiscal year 2000, the rate of treatment for Air Force prostate cancers at Veterans Affairs health care facilities had increased 44 percent and urinary cancer treatment rates including kidney, bladder and ureter cancers, had increased 80 percent.

A small group of former Air Force aviators from the Red River Valley Fighter Pilots Association, which represents about 3,700 veterans who flew all types of aircraft, worked behind the scenes with the Air Force surgeon general to convince the service to look deeper into the issue.

The expanded scope will also use multiple military medical databases, including the Defense Department’s Automated Central Tumor Registry and Air Force Mortality Registry.

LYNPARZA Demonstrated Overall Survival Benefit in Phase 3 PROfound Trial for BRCA1/2 or ATM-Mutated Metastatic Castration-Resistant Prostate Cancer

Only PARP Inhibitor to Improve Overall Survival vs. New Hormonal Agent Treatments for Advanced Prostate Cancer, A Key Secondary Endpoint

AstraZeneca and Merck & Company have announced further positive results from the Phase 3 PROfound trial evaluating LYNPARZA in men with metastatic castration-resistant prostate cancer (mCRPC) who have a homologous recombination repair gene mutation (HRRm) and whose disease had progressed on prior treatment with new hormonal agent (NHA) treatments (e.g. enzalutamide or abiraterone).

Results from the trial showed a statistically significant and clinically meaningful improvement in the key secondary endpoint of overall survival (OS) with LYNPARZA vs. enzalutamide or abiraterone in men with mCRPC selected for BRCA1/2 or ATM gene mutations, a subpopulation of HRR gene mutations.

The Phase 3 PROfound trial had met its primary endpoint in August 2019, showing treatment with LYNPARZA significantly improved radiographic progression-free survival (rPFS) in men with mutations in BRCA1/2 or ATM genes, and had met a key secondary endpoint of rPFS in the overall HRRm population.

The safety and tolerability profile of LYNPARZA was generally consistent with previous trials. The most common adverse events (AEs) ≥20% for LYNPARZA compared to abiraterone or enzalutamide were anemia (47% vs. 15%), nausea (41% vs. 19%), fatigue and asthenia (41% vs. 32%), decreased appetite (30% vs. 18%), and diarrhea (21% vs. 7%). Grade 3 or above AEs were anemia (22% vs. 5%), fatigue and asthenia (3% vs. 5%), vomiting (2% vs. 1%), dyspnea (2% vs. 0%), urinary tract infection (2% vs. 4%), nausea (1% vs. 0%), decreased appetite (1% each) and diarrhea (1% vs. 0%).

Dose interruptions due to an AE of any grade occurred in 45% of patients receiving LYNPARZA and 19% of those receiving an NHA; dose reductions due to an AE occurred in 22% of LYNPARZA patients and 4% of patients who received an NHA. Discontinuation due to AEs occurred in 16% of LYNPARZA patients and 9% in patients who received an NHA.

Dr. José Baselga, executive vice president, oncology R&D, AstraZeneca, said, “Overall survival in metastatic castration-resistant prostate cancer has remained extremely challenging to achieve. We are thrilled by these results for LYNPARZA and we are working with regulatory authorities to bring this medicine to patients as soon as possible.”

Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, “LYNPARZA has demonstrated significant clinical benefit across key endpoints in PROfound, including overall survival for patients with BRCA or ATM mutations, and this reinforces its potential to change the treatment standard for patients with metastatic castration-resistant prostate cancer. These data further support Merck and AstraZeneca’s commitment to uncovering the ways in which LYNPARZA can help patients impacted by cancer.”

This data will be presented at a forthcoming medical meeting.

LYNPARZA was granted Priority Review by the U.S. Food and Drug Administration for patients with HRRm mCRPC in January 2020, with regulatory reviews ongoing in the European Union and other jurisdictions. AstraZeneca and Merck are exploring additional trials in prostate cancer, including the ongoing Phase 3 PROpel trial, with first data expected in 2021, evaluating LYNPARZA as a first-line therapy for patients with mCRPC in combination with abiraterone acetate.

About PROfound

PROfound is a prospective, multi-center, randomized, open-label, Phase 3 trial evaluating the efficacy and safety of LYNPARZA vs. NHA (e.g. abiraterone or enzalutamide) in patients with mCRPC who have progressed on prior treatment with a new hormonal anticancer treatment and have a qualifying tumor mutation in one of 15 genes involved in the HRR pathway, among them BRCA1/2, ATM and CDK12.
The trial was designed to analyze patients with HRRm genes in two cohorts: the primary endpoint was rPFS in those with mutations in BRCA1/2 or ATM genes and then, if LYNPARZA showed clinical benefit, a formal analysis was performed of the overall trial population of patients with HRRm genes (BRCA1/2, ATM, CDK12 and 11 other HRRm genes; key secondary endpoint).

Other secondary endpoints included OS, objective response rate, time to pain progression, rPFS in patients with HRRm genes, and safety.

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.