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Prostate cancer clinical trials

"It worked for me...Think of your family and think about paying it forward.”

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U.S. Army Col. (ret.) Gary Steele was diagnosed with prostate cancer in 2011. After a series of treatments that failed to halt his prostate cancer, Col. Steele and his wife, Mona, traveled to the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center for a second opinion where his medical team suggested a clinical trial.

“I had them explain to me what a clinical trial was because I didn’t know. I was not educated at all on this stuff,” recalled Col. Steele. After talking through their options, Col. Steele says he and his wife decided to participate in the trial.

“We have two sons and I thought that if I end up being okay with this clinical trial, then I could be helping my sons,” he said.

Col. Steele says he has been clean and clear of prostate cancer since late 2015 and credits his ongoing participation in the clinical trial for his success.

“It worked for me. I can only say educate yourself, take care of yourself. Think of your family and think about paying it forward.”

A 4-minute video from the American Association for Cancer Research.

Every FDA-approved prostate cancer drug was tested in clinical trials

To look for better ways to care for people with prostate cancer, doctors create research studies involving volunteers, called clinical trials. Every FDA-approved drug was tested in clinical trials.

Clinical trials are used for all types and stages of prostate cancer. Many focus on new treatments to learn if a new treatment is safe, effective, and possibly better than the existing treatments. These types of studies evaluate new drugs, different combinations of treatments, new approaches to radiation therapy or surgery, and new methods of treatment.

Some clinical trials study new ways to relieve symptoms and side effects during treatment. Others study ways to manage the late effects that may happen a long time after treatment.

People who participate in clinical trials can be some of the first to get a treatment many years before it is available to the public.

Source: Prostate Cancer: About Clinical Trials (American Society of Clinical Oncology, 2021)

"We don't extend lives without research"

“We don’t make advances, we don’t extend lives without participating in research,” says Andrew Armstrong, M.D., a prostate surgeon at  Duke University.  “We’re not happy with the way things are. We want them to be better and the only way to make them better is by studying them.”

Not all of these trials are successful, unfortunately. But many are and that’s why we are seeing men live longer and have better survivorship nowadays.”

Armstrong looks for biomarkers that will identify patients with prostate cancer who are at higher risk for a more aggressive clinical progression of the disease.

Source:  Should Prostate Cancer Patients Consider a Treatment in Clinical Trials? (video, 2021)

Diversifying prostate cancer clinical trials essential for getting the right treatment to all men

Diverse clinical trials matter. Results obtained from diverse clinical trials help medical professionals and researchers understand how race and ethnicity affect prostate cancer risks and outcomes.

Since the majority of participants in clinical trials for prostate cancer are White men, there is little opportunity to study direct effects on People of Color.

Diversifying prostate cancer clinical trials is essential for getting the right treatment to all populations. Non-diverse clinical trials can result in a non-represented population experiencing negative outcomes, such as getting the wrong dose of a drug or receiving a treatment that won’t work as well for their particular needs.

Source: “Prostate Cancer Clinical Trials Need More Diversity” by Ashley Zlatopolsky on the Healthline website (March 18, 2022)

W=Whites 76%, A=Asians 8%, B=Blacks 3%, O=Other or multiple races 2%, AI=American Indian, Alaskan Native, Native Hawaiian or other Pacific Islander 1%, ?=Unknown 11%.

Source: “Race reporting and diversity in US food and drug administration (FDA) registration trials for prostate cancer; 2006-2020.” by M.P. Lythgoe et al. (2021)

In the United States, racial and ethnic minorities have been underrepresented in cancer clinical trials for decades, even when they have a similar or higher risk of the type of cancer being studied. Researchers have found that there are some common barriers that prevent people of color from participating in clinical trials. These include:

Not finding out about clinical trial opportunities. Many people of color don’t find out about clinical trial opportunities because their doctors don’t present them as an option. This can be a major barrier, because many people don’t know how to ask about, research, or find clinical trials on their own without a doctor’s support.

Overly strict eligibility criteria. Every clinical trial has guidelines about who is eligible to join to protect the safety of trial participants and ensure that they share certain characteristics, such as cancer type or previous treatments. But overly strict eligibility criteria have prevented many people from being able to enroll in clinical trials by excluding diseases that disproportionately affect people of color, such as high blood pressure (hypertension), diabetes, HIV, hepatitis B, and hepatitis C.

Travel and transportation. Clinical trial participants often have to travel to a clinical trial site for regular in-person visits which can be time-consuming and expensive. If you lack transportation, can’t take time off from work, or have family caregiving responsibilities, it can be more difficult to participate in a trial.

Out-of-pocket costs. Clinical trials usually pay for anything that is part of the trial, such as the study treatment you’ll receive, while health insurance usually covers routine care costs. But trial participants may have extra, out-of-pocket expenses such as parking, gas, taxis, airfare, and lodging that are not covered by the trial or health insurance. People may also face challenges with insurance coverage during the trial or lost income from time taken off work.

Lack of trust in the healthcare system. People of color may have personally experienced or observed discrimination in a healthcare setting. Or they may have received inferior care; research shows that Black and Hispanic women are less likely than white women to receive breast cancer treatment that adheres to medical guidelines.

All of these barriers contribute to the lack of diversity among clinical trial participants. But the barrier with the biggest impact may be that people of color simply aren’t being told about clinical trial opportunities or asked to participate. “If it’s not presented to you, how are you going to participate?” says Eleanor M. Walker, MD, director of breast radiation oncology for the Henry Ford Health System in Detroit, Michigan.

Read more at “Why are people of color underrepresented in clinical trials? in breastcancer.org’s “Special Report: Increasing Racial Diversity in Breast Cancer Clinical Trials.” 

Page 1 of “Clinical Trial Options For Men With Prostate Cancer,” a 12-page brochure from Zero, the end of prostate cancer and Clovis Oncology, a pharmaceutical company

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“Number one is what are the alternatives that I would have if I did not participate in the clinical trial? What are the standard of care therapies? Prostate cancer now has a vast menu. Many patients don’t necessarily even hear that,” says prostate cancer surgeon Andrew Armstrong, M.D., at the Duke University Cancer Center,

“It’s important to ask about risks. What have other patients experienced going into that study? What’s the evidence that it has helped people before? Why is this so promising?

Then, if you’re hearing about a trial and you’re making a decision to travel, sometimes asking questions about whether the trial will cover your lodging or transportation, gas, money, lodge, airport travel. Some trials do do that.”

A 2-minute video from the Patient Empowerment Network.

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“I think sometimes there’s this misconception that clinical trials should only be utilized when there aren’t any other options,” says Rana R. McKay, M.D.

“Where in fact, I would say clinical trials should be an option to discuss every single time a treatment is being changed, because ultimately the goal is to make sure patients are living longer and living better. And making sure that clinical trials are an option on the table at every juncture is really a key step in that.”

McKay leads a prostate cancer clinic treating men diagnosed with aggressive prostate cancer and teaches at the University of California San Diego School of Medicine.

A 3-minute video from the Patient Empowerment Network.

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“The easiest way to learn about clinical trials is to start start by asking the physician that’s treating you for your prostate cancer,” says prostate surgeon Yaw Nyame, M.D. “Oftentimes they’ll have resources and connections to the trials directly or the people who are administering them.”

“Other great sources are going to be patient advocacy networks. There are many of them for prostate cancer. These are great sources of finding out what clinical trials exist.”

Nyame treats kidney, prostate, bladder and testicular cancers at the Fred Hutchinson Cancer Center and teaches at the University of Washington School of Medicine.

“The trick is navigating all the information and knowing what trials are available for you, whether you qualify and that kind of thing can be difficult.”

A 4-minute video from the Patient Empowerment Network.

ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted in all 50 states and in 221 countries.

The website provides current information about clinical research studies for patients, their families and caregivers, health care professionals, and the public.

Each study record includes a summary of the study protocol, including the purpose, recruitment status, and eligibility criteria. Study locations and specific contact information are listed to assist with enrollment.

Information on ClinicalTrials.gov is provided and updated by the organizations and people that sponsor and carry out the studies. Listing a study does not mean it has been evaluated by the U.S. Federal Government.

Clinicaltrials.gov is a free service of the National Institutes of Health (NIH) and is maintained by the National Library of Medicine (NLM).

For more information about using the database, visit clinicaltrials.gov

“If you decide to look for trials on your own, learn how to find the right clinical trial for you with the National Cancer Institute’s six-step guide:  

  • Step 1: Gather details about your cancer
  • Step 2: Find clinical trials
  • Step 3: Take a closer look at the trials that interest you
  • Step 4: Contact the team running the trial
  • Step 5: Ask questions
  • Step 6: Make an appointment

The NCI’s Cancer Information Service can also provide a tailored clinical trials search that you can discuss with your doctor. To reach them call 1-800-4-CANCER (1-800-422-6237) and select option 2. This is a free service. Keep in mind that the search results do not replace advice from your doctor.

Source: National Cancer Institute (2022)

Get matched to a prostate cancer clinical trial that’s right for you! Print out your results to discuss with your treatment team, or contact the study coordinators directly. Patients are matched to clinical trials by Antidote, a U.S. and U.K. firm that recruits volunteers for clinical trials. 

Go to “Find a clinical trial” at Zero, the end of prostate cancer.

A free, over-the-phone service that helps Black or African American (AA) cancer patients learn more about clinical trials. The Peer Clinical Trials Support Program matches interested patients with a peer — a Black or African American cancer patient or survivor with experience participating in a cancer clinical trial.

Patients have the opportunity to discuss their fears, questions, and concerns with a knowledgeable and empathetic guide, and hear from someone of a similar background who has “been there, done that.”

Source: Cancer Support Community

Our Cancer Immunotherapy Clinical Trial Finder will aid you in finding your answer to cancer. Understand the basics of cancer clinical trials, why clinical trials are so critical to our work, what things to consider about enrolling, and how to assist patients in finding clinical trials for which they may be eligible.

Source: Cancer Research Institute

Publications

Clinical Trial Options

A 12-page brochure addressing the questions: Is a Clinical Trial
Right for You? What’s Meant by Clinical Trial Phases? What Should You Consider Before Joining a Clinical Trial? A Checklist of Questions to Ask.
What Terms Might You Encounter? And some sources of support for prostate cancer patients.

From Zero, the End of Prostate Cancer with support from Clovis Oncology, a U.S. pharmaceutical company that develops cancer treatments.

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