Considering Prostate Cancer Clinical Trials? Here’s What You Need to Know

“Like any other treatment decision we’re looking at risk-benefit ratios, we’re looking at what other options do we have?”

For men with limited options, clinical trials can provide access to the newest treatments that aren’t yet available in general medical settings.  Beyond access to new treatments, clinical trials can have financial benefits: most clinical trials are free to participate in and provide eligible patients with free access to medications, procedures, etc.  While there are many pros to participating in a clinical trial, there are also potential drawbacks to consider before agreeing to participate.  


There are four phases of clinical trials.  Knowing what phase trial the trial you are considering can help you decide if participating in the trial will be beneficial.  

The first and second phases are unlikely to use placebos, but there is also less known about safety and efficacy of the medications.   Phase three trials are more likely to randomize with placebo, but drugs that have made it to phase III trials are also more likely to be effective. 

Phase I. New drugs, looking for dosage and safety

Phase II. Looking for safety and effectiveness 

Phase III. Usually randomized with placebo (or standard of care)

Phase IV.  Observational studies, can look for new indications, etc. 

How do patients make decisions to join a clinical trial? 

Patients who are running out of options (advanced prostate cancer) may choose to participate in a clinical trial.  Occasionally they make this decision based on accessibility of the drug.  If the clinical trial is of a drug they need and are having difficulty accessing in alternative ways (off-label, etc.) or the drug is too expensive, a patient may decide to participate in a clinical trial.  Discussing options and trials with your oncologist is crucial to continue receiving the best care.

How to tell if A clinical trial is working 

PSA, scans, and paying close attention to quality of life and toxicity are all ways to gauge if the clinical trial is working for you.  Making sure to keep your treating doctor in the loop even if they aren’t the doctor conducting the trial.  Open communication is important to keep track of results and monitor safety and effectiveness.  One a patient is accepted and participating in a clinical trial, it is important to note that they can drop out at any time.

Clinical trials vs off-label Therapy

Clinical trials have uncompromising eligibility criteria that patients must meet to be able to participate.  If patients aren’t accepted into the clinical trials they may still be able to get the same drug being used in the clinical trial by having their doctor prescribe it off-label.  Looking at can also be a good way to see what treatments you can consider using in an off-label way.  Occasionally pharmaceutical companies will provide these off-label therapies on a compassionate use basis (free of charge).  

Current prostate cancer trials of note

One big topic of study in prostate cancer is immunotherapy.  Clinical trials researching Keytruda and Amgen’s BiTE platform are promising for the future of prostate cancer care.  Explore for a list of prostate cancer clinical trials, or visit for a list of current and past clinical trials conducted at Prostate Oncology Specialists.

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Explore off-label treatment for prostate cancer: Off-label Treatment Used for Prostate Cancer

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