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If you need treatment for prostate cancer, you may want to think about joining a clinical trial. Like all treatment options for prostate cancer, there are possible benefits and risks, but by looking at all options (including clinical trials) you are taking an active role in the treatment decision-making process for your prostate cancer.

Many men will only start thinking about a clinical trial in an advanced prostate cancer setting. This is because many of the clinical trials include drugs for men with advanced disease or who have previously tried several different treatment options. However, there are prostate cancer trials available for men at all stages of the prostate cancer journey and nearly all men should at least consider the possibility of participating in a trial.

There are several important questions that each patient should ask when considering joining a clinical trial. To help navigate this discussion with your doctor and clinical trial team, some men may find it useful to take notes, record the conversation, or bring a friend/family member to the discussion.

Clinical Trial Questions to Consider

Clinical Trial Phase

  • What is the phase of this clinical trial?

Deciding whether or not to participate

  • How long do I have to make the decision whether or not to participate in the clinical trial?
  • What happens if I decide to take part or not take part in the clinical trial?

How to get more information

  • Who will I get in touch with if I have problems, questions, or concerns?
  • Can I talk to other people taking part in the clinical trial?
  • Is there anything else I can read about this clinical trial?
  • Will I be able to find out about the results of the clinical trial?


  • What were the results of past studies of this treatment? How likely are they to apply to me?
  • What are my other options (standard treatments, other clinical trials)? What are the pros and cons of each?
  • Will the researchers work with my prostate cancer doctor?
  • Will I still see my regular prostate cancer doctor?
  • What kinds of treatments and tests would I need to have? How often are they done?
  • What side effects might I expect from the trial treatment? What are the risks? How do these side effects compare to the side effects from the standard treatment for my prostate cancer?
  • How will we know if the treatment is working?
  • Is long-term follow-up care part of the trial? What would it involve?
  • If the treatment is working for me, can I keep getting it even after the clinical trial ends?
  • Are there reasons I could be removed from the clinical trial? Are there reasons the clinical trial might be stopped early
  • If I am harmed as a result of the research, what treatment will I be entitled to?
  • How long will I be in the clinical trial? How long will the clinical trial last?


  • Would I need to plan on extra time or travel?


  • Will I have to pay for anything? Will my insurance cover the treatment?

Dr. Rettig & Dr. Ardell on Clinical Trials
Dr. Rettig & Dr. Ardell on Clinical Trials

Risks and Benefits of Joining a Clinical Trial

As mentioned, there are several potential benefits and risks to joining a clinical trial. Several of the possible benefits include:

  • You will have access to a new (and potentially helpful) treatment that is not available to men outside of the clinical trial.
  • Your research team will watch you closely.
  • If the treatment under investigation is more effective than the standard of care treatment, you may be among the first to benefit from this treatment.
  • The trial may help prostate cancer researchers learn more about prostate cancer and help patients in the future.

Some of the possible risks of a clinical trial include:

  • The new treatment may not be better than — or may not be as good as — the standard of care treatment.
  • The new treatment may have side effects that your doctors did not expect, which may be worse than the standard of care treatment.
  • You may be required to make more visits to the doctor/research team than you would be expected to have if you were receiving the standard of care treatment.
  • You may need extra tests.
  • Even if the treatment works for some patients, it may not work for you.

Currently, it is estimated that less than 5% of people with cancer in the United States participate in clinical trials, despite the majority of those surveyed expressing some interest. If being part of clinical trial interests you, let your doctors know. Ask them if there are any trials available that may be suitable for you. The advancement of prostate cancer relies heavily on clinical trial participation. The simple answer to the question “When should I consider a clinical trial?” is at any stage of your prostate cancer journey when you feel comfortable with participating in a clinical trial.

Zachary Klaassen, MD, MSc
Urologic Oncologist, Georgia Cancer Center, Augusta University, Augusta, GA, USA