Prostate Cancer Clinical Trials

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.

Learn more about clinical trials in this webinar with Dr. Isla Garraway of UCLA and the Greater Los Angeles VA, and Dr. Samuel Washington of UCSF.

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
apalutamide	ERLEADA®	view PI
cabazitaxel	JEVTANA®	view PI
darolutamide	Nubeqa®	view PI
denusomab	XGEVA®	view PI
enzalutamide	XTANDI®	view PI
lutetium Lu 177 vipivotide tetraxetan	PLUVICTO®	view PI
olaparib	LYNPARZA®	view PI
pembrolizumab	KEYTRUDA®	view PI
radium-223	XOFIGO®	view PI
relugolix	ORGOVYX®	view PI
rucaparib	RUBRACA®	view PI
sipuleucel-T	PROVENGE®	view PI
talazoparib	TALZENNA®	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)

What are some questions I may want to ask my study doctor?

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?

If you decide that a clinical study may be right for you, make a list of questions and discuss them with the study doctor at your initial visit.

What happens after a study is complete?

After a study is complete, the FDA decides whether to continue or halt the drug’s development. If it remains in development, the sponsor may build in a compassionate use extension for the study. This means that eligible patients may receive the study drug for a predefined amount of time without having to undergo any typical study procedures, such as blood tests or clinical ratings. This usually occurs in later studies, such as Phase III and Phase IV (post-marketing surveillance).

In some cases, a study doctor may dispense approved medication samples and provide additional consultation free of charge. These are just a few of the ways he or she might show appreciation for a patients involvement in a study.

What are the phases of the clinical trial process?

There are three primary phases an investigational drug has to go through before it can be approved by the FDA, and a fourth phase that an approved drug may enter.

Phase I

In this phase of a clinical trial, the sponsor wants to determine the maximum tolerated dose for the medication. Mode of action (how the drug exerts its effects), safety and side effects – these are some of the main issues that are of the utmost concern to drug makers at this stage of the clinical trial process. It is important to note that in Phase I studies, the overall safety of the medication in patients has not been established. Efficacy in Phase I, if observed, must be considered anecdotal until confirmed in more advanced studies.

Phase II

A drug reaches Phase II only when the FDA has reviewed the Phase I data and concludes that the drug is safe for patients, and that its clinical activity may be beneficial against a particular disease or condition. At this point, a larger group of patients are enrolled and condition- or disease-specific rating scales are used to record data. The goals are to continue safety assessment and to determine dosage for pivotal, Phase III efficacy trials.

Phase III

This is an important turning point for drug development. The medication has already passed the rigorous testing and review process required by the FDA, and now it is ready to be studied in an even larger patient population, with even more advanced rating scales and clinical measures. In recent years, there has been a growing industry trend to not only measure clinical effectiveness at this phase, but also measure “real world” results. For example, if patients show clinical improvement after entering the study, how are their activities of daily living improving (e.g., patients can work in the garden more often or attend their child’s games on a regular basis)? Most medications that reach Phase III will at least be considered for approval by an FDA advisory board.

Phase IV

At this phase in development, the drug has already been granted FDA approval. Phase IV studies are often performed to either identify an additional use for an already approved drug, or to gather additional safety information from a larger group of patients. In some cases, Phase IV studies are implemented to establish effectiveness in a subgroup of patients, for example, patients over age 65.

How are a participant’s rights safely protected?

The FDA is the governing agency that develops the policies and guidelines for all clinical research, regardless of manufacturer, study phase or drug type. There are also independent Institutional Review Boards (IRB) at institutions that review and approve all study-related documents, such as protocols, Informed Consent forms, physician credentials and eligibility, and patient recruitment materials, such as print advertisements and public service announcements. (See “Protocol” and “Informed Consent” Form in the “Common Terms Used in Clinical Trials” section.)

Why are clinical trials important?

There are several reasons why clinical trials are important. First, the participant may have a positive response to the study medication, and his disease or condition may improve. In addition, participants receive free laboratory and medical testing. More often than not, the study medication is in development because it works differently than other drugs on the market, and therefore, it may present an alternative course of treatment for the patient.

Second, participation in a clinical trial helps manufacturers make informed decisions about whether to pursue getting a particular drug approved by the Food & Drug Administration (FDA). In the best-case scenarios, these data can help get a new medication approved by the FDA, and ultimately continue the industry’s efforts in developing medications that are safer, more effective, and work faster than any before them.

What are clinical trials?

A clinical trial is the investigation of a new treatment for a disease. The work might be sponsored by a pharmaceutical or biotechnology company, government, university, or a private foundation. The purpose of these studies is to find out whether a new treatment or medical technology (such as imaging or medical devices) is safe to use and effective for various diseases or medical conditions. In order to study the treatment, several questions need to be answered first. For example, what patient population or disease is a drug likely to be effective in? What criteria should be used for accepting participants into the study? What general and disease-specific information are the study doctors going to obtain?

Essentially, once these and other important study questions are answered, the study doctors (investigators) are chosen, the regulatory documents are approved and the study is ready to begin.

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

Open Trials

For a complete list of open trials in the United States, please visit:

ECOG-ACRIN Cancer Research Group

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://www.clinicaltrials.gov/study/NCT04423211

ClinicalTrials.gov identifier: NCT04423211

Merck logo

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

Title: A Phase II Trial of Focal Ultrahypofractionated Stereotactic Radiation Therapy for the Treatment of Unifocal Prostate Cancer (FOCUS-RT)

NCT: NCT05616650

Informational Video: https://youtu.be/HQj6gWhV5fc?si=ou1GfodMlEL4B9fW

Background:

The current standard treatment of prostate cancer is either surgery or radiation. Typically, this includes either the removal or radiation of the whole prostate gland. Many people now seek out focal therapy options to decrease the side effects of treatment. Until now, several forms of physical destruction with heat (thermal ablation), cold (cryotherapy), sound waves (HIFU), laser (FLA), and electrical energy (IRE). A new type of radiation (SBRT) may be an effective way to cure men of early-stage prostate cancer with fewer side effects than standard treatments.

What the Study Entails

Participants will undergo screening including blood tests, an MRI, a PSMA PET/CT (18F-DCFPyL), and a biopsy.
Small, non-radioactive, gold seeds about the size of a grain of rice will be placed in and/or around the tumor to help target the radiation treatment.
Radiation (SBRT) will occur in 2 separate sessions about 1 week apart. No sedation is used, these sessions are painless. Each session will take about 1-2 hours. Participants can go home afterwards.
Follow-up will continue for 2 years with repeat scans (MRI and PSMA PET/CT) and blood (PSA) tests.
After two years, a biopsy will be done to understand the impact of this new treatment on prostate cancer.

Study Lead Investigator

Krishnan R Patel, MD, MHS, National Cancer Institute (NCI)

Study Site

The National Institutes of Health (NIH), Clinical Center
Bethesda, MD in the Washington, DC metro area

Referral Contact:

Debbie Nathan, R.N.
National Cancer Institute (NCI)
National Institutes of Health
(301) 451-8968
[email protected]

Title: ¹⁸F-DCFPyL Imaging as a Method to Assess Treatment Response to Stereotactic Body Radiation Therapy

NCT: NCT05155046

Background: Radiotherapy is a highly effective treatment for localized prostate cancer; however, recurrence is more common in patients with unfavorable intermediate and high-risk prostate cancer and is usually diagnosed by rising prostate specific antigen (PSA – biochemical failure).

Early identification of disease persistence or recurrence before meeting criteria of biochemical failure may allow effective potentially curative salvage treatment, but identification of local recurrence or persistence at early stages is challenging. CT imaging is relatively insensitive at localizing recurrence, while MRI is more sensitive for local recurrence but is non-specific.

Prostate specific membrane antigen (PSMA) targeted PET imaging was recently FDA approved for imaging men with suspected prostate cancer metastases who are potentially curable by radiation or surgery. PSMA based imaging has been used in prospective trials to define extent of disease and to alter radiation treatment volumes.

¹⁸F-DCFPyL, a second generation PSMA PET agent that binds with high affinity to PSMA yet clears rapidly from the blood pool, has recently been approved by the FDA as a method to stage high risk cancer and detect recurrent disease.

Primary Objective: To define ¹⁸F-DCFPyL PET/CT imaging response in participants with localized prostate cancer after treatment with stereotactic body radiation therapy (SBRT) with or without androgen deprivation therapy (ADT).

What the Study Entails:

All participants will undergo ¹⁸F-DCFPyL PET/CT and mpMRI 6 months following completion of SBRT and at recurrence, if applicable.
Participants receiving neoadjuvant androgen deprivation therapy will undergo a second ¹⁸F-DCFPyL PET/CT and multiparametric MRI (mpMRI) at 8 weeks after initiation of ADT but before SBRT.
Participants will be followed for up to 2 years after completion of SBRT to evaluate longitudinal quality of life and biochemical control.

Study Lead Investigator
Deborah Citrin, MD, National Cancer Institute (NCI)

Study Site
The National Institutes of Health (NIH), Clinical Center
Bethesda, MD in the Washington, DC metro area

Referral Contact:
Debbie Nathan, R.N.
National Cancer Institute (NCI)
National Institutes of Health
(301) 451-8968
[email protected]

Title: Screening Study for Men at High Genetic Risk for Prostate Cancer

NCT: NCT03805919

About the Study

The National Cancer Institute opened a clinical trial for prostate cancer screening in men who are at high risk for prostate cancer due to an inherited mutation.

What the Study Entails

Screening MRI of the prostate every 2 years
Annual PSA blood test
Biopsy of the prostate if any MRIs are abnormal
No cost for study-related tests or procedures
No cost for travel
Clinical information will be shared with you and your doctor, if you choose
Genetic testing is not offered as part of the study

Study Lead Investigator
Fatima Karzai, MD, National Cancer Institute (NCI)

Study Site
The National Institutes of Health (NIH), Clinical Center
Bethesda, MD in the Washington, DC metro area

Study Contact:
Anna Couvillon, N.P.
National Cancer Institute (NCI)
National Institutes of Health
(240) 858-3148
[email protected]

Additional open trials can be found by going to:

Literature:

Cancer Clinical Trials: A Commonsense Guide to Experimental Cancer Therapies and Clinical Trials

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 »

https://www.pcf.org/patient-resources/patient-navigation/prostate-cancer-clinical-trials/