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NCCN Guidelines for Patients


Prostate Cancer, Version 1.2016


Overview of cancer treatments Clinical trials | Understudied treatments

Clinical trials

New tests and treatments aren’t offered to the public

as soon as they’re made. They need to be studied. A

clinical trial is a type of research that studies a test or


Clinical trials study how safe and helpful tests and

treatments are. When found to be safe and helpful,

they may become tomorrow’s standard of care.

Because of clinical trials, the tests and treatments

in this book are now widely used to help men with

prostate cancer. Future tests and treatments that

may have better results than today’s treatments will

depend on clinical trials.

New tests and treatments go through a series of

clinical trials to make sure they’re safe and work.

Without clinical trials, there is no way to know if a test

or treatment is safe or helpful. Clinical trials have four

phases. Examples of the four phases for treatment


Phase I

trials aim to find the best dose of a

new drug with the fewest side effects.

Phase II

trials assess if a drug works for a

specific type of cancer.

Phase III

trials compare a new drug to the

standard treatment.

Phase IV

trials test new drugs approved by

the U.S. FDA (


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in many patients with different types of cancer.

Joining a clinical trial has benefits. First, you’ll have

access to the most current cancer care. Second, you

will receive the best management of care. Third, the

results of your treatment—both good and bad—will be

carefully tracked. Fourth, you may help other people

who will have cancer in the future.

Clinical trials have risks, too. Like any test or

treatment, there may be side effects. Also, new tests

or treatments may not help. Another downside may

be that paperwork or more trips to the hospital are


To join a clinical trial, you must meet the conditions

of the study. Patients in a clinical trial are often alike

in terms of their cancer and general health. This is to

know that any progress is because of the treatment

and not because of differences between patients.

To join, you’ll need to review and sign a paper called

an informed consent form. This form describes the

study in detail. The study’s risks and benefits should

be described and may include others than those

described above.

Ask your treatment team if there is an open clinical

trial that you can join. There may be clinical trials

where you’re getting treatment or at other treatment

centers nearby. You can also find clinical trials

through the websites listed in Part 8.

Understudied treatments

The treatments described so far are those approved

by NCCN experts. These treatments have been

proven in clinical trials to be safe and work well.

You may have heard about other treatments. Some

treatments that are of great interest but need more

research are addressed next.

Cryosurgery as initial treatment

Cryosurgery is a treatment option following failure of

radiation therapy. It is not recommended as an initial

treatment at this time. More research is needed to

compare cryosurgery to prostatectomy and radiation