Clinical trials bring life extending and curative new treatments to cancer patients. Clinical drug trials play a vital role in moving new treatments to patients who need them most, securing data so regulatory approvals can be obtained and new drugs can move into widespread clinical practice. Patients who participate in clinical trials provide an invaluable service both to treatment science and fellow patients.
There are currently nearly 100 Phase III trials and more than 500 Phase I/II trials related to prostate cancer in progress in the United States alone. Those that are approved will join the many drugs that have been approved for men with advanced/metastatic disease and further improve outcomes for patients:
|Agent||Brand Name||Package Insert|
|abiraterone acetate||YONSA®||view PI|
|abiraterone acetate||ZYTIGA®||view PI|
|lutetium Lu 177 vipivotide tetraxetan||PLUVICTO®||view PI|
|niraparib (+ abiraterone acetate)||AKEEGA®||view PI|
The resources on this page can direct you to clinical trials that are currently open for enrollment in your local area, as well as across the country. If you are considering a clinical trial, speak to your doctor about the potential benefits of participating in a trial so you can make an informed decision that is best for you.
Frequently Asked Questions (FAQs)
- How long does the average trial last?
- What if I am on other medication(s) from my regular doctor?
- What are the risks involved?
- What if I am harmed?
- Are there any tests requiring painful shots or blood samples?
- What should I do if I want a friend/parent to join a study?
- Will I be paid?
- Will I be reimbursed for gas?
- What kinds of medical problems would prevent participation in the clinical trial?
- Do I have to talk to my health insurance company before enrolling in a study?
- What if I miss a dose?
- Can I drop out at any time?
- Are there placebos involved?
Prostate Cancer Clinical Trials Consortium
The Prostate Cancer Clinical Trials Consortium (PCCTC) is a clinical research group sponsored by the Prostate Cancer Foundation and the Department of Defense Prostate Cancer Research Program (PCRP), with its Coordinating Center headquartered at Memorial Sloan Kettering Cancer Center. The PCCTC is currently composed of 15 participating clinical research sites and 32 affiliated clinical research sites.
Visit the PCCTC site for trial information: www.pcctc.org
The INDICATE Study (EA8191) – Treating Prostate Cancer That Has Come Back after Surgery with Apalutamide and Targeted Radiation Based on PET Imaging
Do you have prostate cancer that has returned after prostatectomy? If so, you may be able to participate in this study of potential new treatment approaches. In the EA8191/INDICATE study, all participants will receive the usual treatment for prostate cancer that recurs after surgery, which is radiation therapy (RT) to the prostate bed and pelvic lymph nodes, combined with short-term (6 months) androgen deprivation therapy (STAD), also sometimes referred to as hormone therapy. In addition:
– Some patients will receive additional PET imaging, depending on the results of their initial PET scan.
– Some patients will also receive a type of hormone therapy called apalutamide, which is approved by the FDA for treatment of your prostate cancer.
– Some patients, depending on the results of their initial PET scan, will receive metastasis-directed radiation therapy.
To decide which of these approaches is better, doctors on the study team will be looking to see if your cancer responds, and if it returns again, how much time passes after your treatment before it returns.
To learn more about this study and to find out if you may be eligible, please visit: https://clinicaltrials.gov/ct2/show/NCT04423211
ClinicalTrials.gov identifier: NCT04423211
CONTACT-02: Phase 3 Study of Cabozantinib With Atezolizumab in mCRPC
CONTACT-02 is a clinical trial investigating the safety and efficacy of the combination of two drugs, cabozantinib and atezolizumab, in men with metastatic castration-resistant prostate cancer (mCRPC). Men must have cancer that worsened despite treatment with one novel hormonal therapy (such as abiraterone, apalutamide, enzalutamide, or darolutamide). Additional eligibility criteria apply.
Cabozantinib tablets are taken once a day by mouth. It is a type of drug called a tyrosine kinase inhibitor (TKI). TKIs such as cabozantinib may block proteins that signal cells to grow, divide, and spread. This may slow or stop the growth of some types of cancer cells.
Atezolizumab is a different type of drug called an immune checkpoint inhibitor (ICI) and is given intravenously. ICIs may strengthen the activity of your immune system to recognize and attack cancer cells.
The use of cabozantinib and atezolizumab described here is investigational, which means that they are not currently approved to treat mCRPC.
To learn more about this study and to find out if you may be eligible, please visit: https://clinicaltrials.gov/ct2/show/NCT04446117
ClinicalTrials.gov identifier: NCT04446117
Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)
Merck is conducting this clinical trial to find out if the investigational medication pembrolizumab in combination with abiraterone and prednisone is safe and works to slow down or stop the growth of metastatic Castrate Resistant Prostate Cancer (mCPRC). Pembrolizumab is a type of immunotherapy, which may help the body’s immune system attack cancer cells. This trial is currently enrolling patients with mCRPC who have not received chemotherapy for mCRPC and have either not had prior second generation hormonal manipulation for mCRPC, or have previously been treated with enzalutamide for mCRPC and failed treatment or has become intolerant of the drug. Additional eligibility criteria will apply. Click here to learn more about this trial on the sponsor’s website.
To learn more about this study and to find out if you may be eligible, please visit: https://clinicaltrials.gov/ct2/show/NCT02861573
ClinicalTrials.gov Identifier: NCT02861573
Myovant Sciences is conducting a clinical study to learn about the safety and tolerability of relugolix in combination with medications approved for use in combination with androgen-deprivation therapy (ADT) for the treatment of patients with metastatic castrate-sensitive prostate cancer (mCSPC), non-metastatic castrate-resistant prostate cancer (nmCRPC) and metastatic castrate-resistant prostate cancer (mCRPC).
Relugolix is an oral, FDA-approved medication. The clinical study will have three parts. Patients with advanced prostate cancer will participate in only one of the three parts of the clinical study.
Part 1: Relugolix in combination with abiraterone acetate and a corticosteroid
Part 2: Relugolix in combination with apalutamide
Part 3: Relugolix in combination with docetaxel with or without prednisone
Patients currently being treated with leuprolide acetate (Lupron® or Eligard®) or degarelix (Firmagon®) in combination with abiraterone acetate (Zytiga®)/fine-particle abiraterone acetate (Yonsa®), apalutamide (Erleada®), or docetaxel (Taxotere®) may be eligible to participate. Additional eligibility criteria will apply.
To learn more about this study please visit: https://clinicaltrials.gov/ct2/show/NCT04666129
ClinicalTrials.gov identifier: NCT04666129
Additional open trials can be found by going to:
Tomasz M. Beer, MD
Larry Axmaker, Ed.D.
Written from both a patient and clinician perspective by Larry Axmaker, Ed.D., and Tomasz M. Beer, MD, a PCF-funded researcher, this book is an insightful resource for anyone considering clinical trials in addition to standard cancer therapy. Order Here »