Have you been diagnosed with prostate cancer? Are you wondering if a clinical trial is right for you? Many people participate in clinical trials to access new medications or help researchers discover more effective treatment options. But clinical trials aren’t for everyone.

Keep reading to learn more about clinical trials, their advantages and disadvantages, and whether they’re right for you. Be sure to speak with your cancer care team about clinical trials and how to participate.

What Are Clinical Trials?

Clinical trials are medical research studies that explore new treatments and prevention strategies. Trials are important because they help scientists discover new — and potentially better — treatment options. Nearly all clinical trials go through intense testing over many years to make sure the treatment is effective and safe for the public.

Types of Clinical Trials for Prostate Cancer

There are four main types of clinical trials for cancer.

• Treatment trials — These study new treatments or different ways to use existing treatments.
• Prevention trials — These find ways to prevent cancer or its complications from developing.
• Screening trials — These discover effective early detection methods.
• Supportive care/palliative care trials — These test ways to improve quality of life and reduce side effects from cancer treatment.

As of January 2025, there are about 1,100 trials for prostate cancer looking for participants and about 590 actively testing. These studies include:

• Hormone therapy approaches
• Immunotherapy treatments
• Combination treatments
• Surgical techniques
• Radiation techniques
• Symptom management strategies

Understanding Clinical Trial Phases

Clinical trials go through four main phases. As they advance through phases, the trial is applied to a broader and more diverse group of people to find out if the experimental treatment is safe and effective.

Before any phase begins, the U.S. Food and Drug Administration (FDA) must approve the research and deem the medication an investigational new drug (IND). The FDA needs to see preclinical safety studies, usually done in animals such as mice, that show the drug can be tested on people. The FDA also needs detailed documentation, including information on how the drug is made, planned safety measures for participants, and who will run the clinical trial.

The research team also needs to receive informed consent from everyone who will participate. This means participants will sign a document that provides all trial details.

Informed consent paperwork includes:

• Detailed information about the trial and the drug being tested
• Possible risks and benefits
• Any related incentives and costs (and who’s responsible for them)
• The primary investigator’s and research coordinator’s contact information

The clinical trial may begin only once it’s approved by an ethics review board and participants have provided informed consent. To understand each phase, let’s discuss them as if an experimental drug were undergoing trials to treat prostate cancer.

• Phase 1 — This is the earliest and smallest phase, with the main goal of seeing if the drug is safe. The dose is gradually increased until researchers find the most effective level with an acceptable set of side effects.
• Phase 2 — The next phase tests whether the treatment works. The drug needs to achieve its targeted efficacy (effectiveness) with few side effects to continue.
• Phase 3 — This phase is used to compare a new treatment to the current standard treatment in a large group of people to see which works better. These studies are sometimes blinded, meaning neither you nor your doctor knows which treatment you’re getting, but not always. In most cancer trials, you will get at least the standard treatment, rarely a placebo (inactive treatment) alone.
• Phase 4 — During the last phase, the drug is released to the general public, but the FDA wants to discover more about it, such as safety over time, cost-effectiveness, and rare side effects among thousands of people. This phase lasts many years after FDA approval.

How Safe Are Clinical Trials?

All trials follow strict safety rules set by an institutional review board (IRB). An IRB is an ethics committee that reviews, approves, and monitors clinical trials to protect every participant’s rights and well-being. If they see an issue with a trial, they can pause or stop all research to prevent serious physical or mental harm. An IRB can also stop a trial if it thinks that the new drug is not working as expected.

Advantages of Clinical Trials

Joining a clinical trial can have several benefits. You may have access to new treatments, additional monitoring, and the opportunity to help advance research for others with prostate cancer. You may also receive financial incentives for participating in a clinical trial.

Access to New Treatments

Some clinical trials offer the latest cancer treatments that aren’t available to others. You’ll have access to medications, surgical or radiotherapy techniques, and other options. The research team or sponsor usually covers the cost of the main treatment, but you or your insurance may need to cover your own travel and some medical services (like imaging and laboratory tests).

Extra Monitoring

During a trial, you’re closely monitored by the oncologist (cancer specialist) and team as they carefully collect data and provide treatment. You likely have more doctors and nurses frequently checking on you to see how you’re responding.

Advancement of Research

Being a part of a clinical trial can be rewarding. You’ll have the opportunity to help others with prostate cancer find treatments that help them recover, manage symptoms, and improve their quality of life. Every participant plays a role in advancing science and potentially discovering the next breakthrough.

Financial Incentive

Many trials offer a reasonable financial incentive, typically in the form of gift cards or vouchers, to compensate for your time, effort, and travel expenses.

Disadvantages of Clinical Trials

Unfortunately, signing up for clinical trials can have drawbacks. These include unknown side effects, extra visits, and the risk of receiving a less effective treatment.

Unknown Side Effects

Since you would be taking an experimental treatment, the side effects are unknown, especially those not discovered in previous phases or other studies. While many side effects go away after treatment, there is a risk that you’ll experience serious or long-lasting ones. If you’re in a clinical trial and experiencing symptoms, you should always talk to your care team to evaluate whether it’s appropriate to continue.

Extra Tests and Visits

While extra monitoring is a benefit, it also demands a greater time commitment than typical prostate cancer treatments. You may need to follow strict directions related to your care plan, keep a health journal, and go to all scheduled appointments according to the trial’s schedule. Depending on the location of the study site, you may need to account for commuting or travel.

Risk of Less Effective Treatment

Even if the treatment has shown positive results in earlier research, it may not work for you because every person’s body and cancer are different. There is also a chance that the experimental treatment is less effective than the standard treatment.

Is a Clinical Trial Right for You?

You can find out if a clinical trial is the best next step by talking to your care team. Some studies are recruiting people based on specific cancer stages or ages, so your oncologist can help you find trials that you’re eligible to join.

Remember, if you choose to join but change your mind, you can withdraw your consent and exit the trial at any time.

Ask Questions About the Trial

If you’re curious about joining a clinical trial, it’s OK to ask the study doctor for details. Below is a short list of questions to help you learn more.

• What are the risks of joining this study?
• Will I be paid for my time or reimbursed for my travel?
• Do I have to attend all follow-up visits in person, or is telehealth allowed?
• Do I need to discuss this trial with my insurance company?
• How long does this study last?
• Am I allowed to take my other medications?

Join the Conversation

On MyProstateCancerTeam, people share their experiences with prostate cancer, get advice, and find support from others who understand.

Have you joined a clinical trial for prostate cancer? Let others know in the comments below.