Finding out you have cancer can be scary and confusing. Luckily, doctors and researchers are working hard to find new ways to beat all types of cancers, including prostate cancer. 

The prostate is a small gland found only in men. It is located below the bladder and wraps around the urethra, which helps excrete urine. Prostate cancer happens when cells in the prostate form a mass called a tumor. At first, these prostate cancer cells may stay inside the prostate. But in later stages, they can spread to other parts of the body.

About one in every eight men will get prostate cancer in their lifetime, but it mainly affects men over 65 years old. Black men have a higher mortality rate, so screening is even more critical. The Prostate Cancer Foundation even has screening guidelines to improve the disparity. With early treatment, prostate cancer can be cured. Dr. Yaw Nyame, MD, MS, MBA, of the Fred Hutch Cancer Center says, “Prostate cancer aggressiveness varies at diagnosis with nearly 30 to 50 percent of cases being low-risk cancers that don’t require treatment. The remaining cancers are aggressive and benefit from treatment based on cancer stage…” Clinical trials are an important part of this fight. 

What are Clinical Trials?

When it comes to prostate cancer, clinical trials are particularly important because the tumors can vary so greatly. “While prostate cancer is the second leading cause of cancer mortality among men in the US, most men diagnosed with prostate cancer have a more slow-growing cancer that may be cured with surgery or radiation, or could even initially be carefully monitored (active surveillance). There is information about a patient’s prostate tumor’s aggressiveness in its Gleason score, the stage of the tumor, and there are also some genomic tests that can help identify which cancers are more aggressive, which ones can be treated and cured, and which ones can be safely monitored,” explains Dr. Lorelei Mucci, Director of Strategic Research Partnerships at the American Cancer Society and Director of the Cancer Epidemiology and Cancer Prevention Program at the Harvard T.H. Chan School of Public Health (HSPH). 

A clinical trial is a special kind of research study in which doctors test new treatments or prevention methods. Volunteers are selected based on their cancer stage, as well as their age and other demographic factors. From trials, researchers learn the best techniques or combinations thereof to treat more people and save more lives. 

There are four distinct phases of clinical trials:

• Phase 1: A new treatment is tested on a small group to see if it is safe
• Phase 2: The treatment is given to more people to see how well it works
• Phase 3: The new treatment is compared to standard treatments
• Phase 4: Researchers learn more about the safety and effectiveness of an approved treatment

Benefits of Participating in a Prostate Clinical Trial

Dr. Mucci says that clinical trials test novel therapies or new combinations of therapies that are not otherwise available to patients. “Trials may also test new interventions or approaches such as whether exercise can improve outcomes during cancer care. When a trial is conducted, the hypothesis is that this new approach will be better than what is the standard clinical care,” she adds. Some (not all) study sponsors pay for participants’ medical care. Also, volunteers typically receive increased access and visits with their clinical team, which can help with overall health.

Early access to new medicines or therapies before they are widely available can be lifesaving for some volunteers. Of course, participation also benefits the greater good. After all, the findings help doctors act faster and smarter in the face of future cases. 

Types of Clinical Trials for Prostate Cancer

Many different clinical trials are going on right now for prostate cancer. Each tests a promising new treatment option, including immunotherapy, chemotherapy combinations, and more. Here are a few examples:

Immunotherapy

Immunotherapy is an exciting new way to treat cancer. Medicines boost your own immune system to find and attack cancer cells. For example, a trial called KEYNOTE-199 is testing an immunotherapy drug called pembrolizumab. Early results show it may help men with advanced prostate cancer live longer.

Targeted Therapy

Targeted cancer therapies attack specific molecules inside cancer cells. They often cause fewer side effects. The TRITON3 trial is testing a targeted therapy drug called rucaparib, which focuses on DNA repair in prostate cancer cells. Rucaparib may help men with mutations linked to more aggressive prostate cancer.

Hormone Therapy

Most prostate cancer cells need testosterone to grow. Hormone therapy lowers testosterone levels, slowing cancer growth. The ENZAMET trial is adding hormone therapy to the normal first-line treatment for metastatic prostate cancer. Researchers hope the combination will prove effective.

Finding a Prostate Clinical Trial

Talk to your medical team about whether a clinical trial may be a good option in your fight against prostate cancer. Search online databases like ClinicalTrials.gov for prostate cancer studies in your area. Contact local cancer centers, to ask if they are running any prostate cancer trials. Look into advocacy groups, like the Prostate Cancer Foundation and Us Too, that list prostate cancer trials their experts have reviewed. BDO also offers a Clinical Trial Resource Center for Black Americans.

When you find a trial that matches your cancer type and stage, discuss the options with your medical team and family to decide if participation is worthwhile.

Key Considerations for Participation

Before joining a prostate cancer clinical trial, evaluate eligibility criteria closely. Researchers establish standards for age, cancer genetics, stage, prior treatments, and health status. Understanding eligibility limits disappointment and rejection. Trials also involve regular appointments and tests, which may or may not be paid for by the research team or the patient’s insurer. Factor in these medical expenses, location, travel, employment, and inconvenience before accepting to join a trial. In addition to costs and burden to patients, Dr. Nyame adds that interventions may introduce some unknown toxicities or simply not benefit a trial participant at all.

The American Cancer Society created a detailed document describing patient-level factors to consider. These are some of the questions to answer if you are thinking about joining:

• What are my goals, and what do I expect if I decide to take part? How realistic are these?
• How sure are my doctors about my future if I decide to take part (or not take part) in this clinical trial?  
• Do I have all the information I need to make an informed decision?
• Have I weighed the benefits against the risks?
• Have I considered other factors, such as travel, time, and money?
• Have I looked at my other options?

Final Thoughts

Before leaping into a prostate cancer clinical trial, follow Dr. Nyame’s advice. “[T]ake time to understand the risks and benefits of treatment, what the additional costs may be (extra visits or tests), and what resources the study may have to support your participation (i.e., stipends for travel/lodging, coverage for tests, etc.),” he suggests.

Have your doctor explain the trial’s risks and benefits in detail so you understand what’s involved. “Of course, with a randomized trial, the patient will not know whether they will get the new therapy or standard of care when they enroll in a trial,” adds Dr. Mucci. So, it’s important to get support not just at the beginning but through the entire trial process. Talk to friends and family about joining so they can support your decision—no matter the outcome.