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. 

There are currently nearly 100 Phase III drug trials and more than 500 Phase I/II trials related to prostate cancer treatment in progress in the United States alone. Those that are approved will join the 12 new drugs that have been approved for men with advanced/metastatic disease since 2010 and further improve outcomes for patients:

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?
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.
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.
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.
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.)
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.
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 11 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:
clinicaltrials.go



Tmunity

CART-PSMA-TGFβRDN-02 Study

Tmunity Therapeutics is now enrolling men in a Phase 1 single-arm study, who have metastatic castration‐resistant prostate cancer (mCRPC) investigating a new Chimeric Antigen Receptor T (CART) cell treatment, which uses the body’s own immune system (a type of white blood cells called “T” cells) to attempt to attack prostate cancer cells.

Eligible participants will undergo leukapheresis, a process that collects the participant’s own white blood cells. These cells are then genetically modified in a lab so the cells will be able to target the participant’s prostate cancer tumor cells once infused back into the participant. These genetically modified cells are called CART-PSMA-TGFβDN cells.

To be eligible for this trial, patients with metastatic castration-resistant prostate cancer must have received at least 2 prior lines of therapy for prostate cancer. Additional eligibility criteria will apply.

To learn more about this study and to find out if you may be eligible, please visit: https://clinicaltrials.gov/ct2/show/NCT04227275


PCF

The MAGNITUDE Study

WHY IS THIS CLINICAL RESEARCH STUDY BEING DONE?
The MAGNITUDE Study is a Phase 3 randomized, placebo­-controlled, double-­blind study comparing a combination of an investigational medicine and standard treatment, to a combination of a placebo and standard treatment for men with metastatic prostate cancer.

AM I ELIGIBLE?
You may be eligible to participate in this study if you:

  • Are a male, age 18 or older
    Have a diagnosis of metastatic prostate cancer (which means that cancer has spread to other parts in your body such as bones, liver or lung)
  • Are willing to provide a blood sample and tumor tissue sample as part of the study

Before you participate in this study, a detailed description of the study, as well as possible risks and benefits, will be provided in writing in an “informed consent document” and discussed with you. You will be asked to review and sign the informed consent document prior to participating. Your medical history will be reviewed, and you will be given a study­required medical exam and have study­-required laboratory tests such as blood draws.

STUDY DESIGN
The purpose of the study is to compare a combination of the investigational medicine to standard treatment versus a combination of placebo and standard treatment for the treatment of patients with metastatic prostate cancer. A placebo is an inactive treatment, sometimes referred to as a “sugar pill,” that will be provided as capsules and will match the investigational medicine in size, weight, color, shape, and taste

Once enrolled in the study, feel free to discuss your investigational medication with the study doctor or research staff at any time during the study. Information collected during a clinical research study may or may not ultimately lead to the investigational medicine(s) being approved by regulatory health authorities.

Your participation in the study is voluntary and you can leave the study at any time. Compensation for time and travel may be available.

To learn more about this study and to find out if you may be eligible and if the study is being conducted at a site near you, please visit:
https://clinicaltrials.gov/ct2/show/NCT03748641?term=NCT03748641&rank=1


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


Merck logo

Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641)

Merck is conducting this clinical trial to find out if the investigational medication pembrolizumab in combination with enzalutamide is safe and works to slow down or stop the growth of metastatic Castrate Resistant Prostate Cancer (mCPRC) compared to enzalutamide alone. Pembrolizumab is a type of immunotherapy, which may help the body’s immune system attack cancer cells. To be eligible for this trial, patients with mCRPC must not have received chemotherapy for mCRPC and have either not received treatment with abiraterone acetate or have received treatment with abiraterone acetate but did not respond or are no longer responding to it. 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/NCT03834493

ClinicalTrials.gov Identifier: NCT03834493


Merck logo

Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)

Merck is conducting this clinical trial to find out if the investigational medication pembrolizumab in combination with docetaxel and prednisone is safe and works to slow down or stop the growth of metastatic Castrate Resistant Prostate Cancer (mCPRC) compared to docetaxel and prednisone alone. Pembrolizumab is a type of immunotherapy, which may help the body’s immune system attack cancer cells. To be eligible for this trial, patients with mCRPC must not have received chemotherapy for mCRPC and have received prior treatment with either abiraterone acetate or enzalutamide (but not both). 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/NCT03834506

ClinicalTrials.gov Identifier: NCT03834506


Merck logo

Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010) (KEYLYNK-010)

Merck is conducting this clinical trial to find out if the combination of two investigational medications, pembrolizumab and olaparib, is safe and works to slow down or stop the growth of metastatic Castrate Resistant Prostate Cancer (mCRPC) compared to the standard of care. Pembrolizumab is a type of immunotherapy, which may help the body’s immune system attack cancer cells. Olaparib is a targeted therapy called a PARP inhibitor that may help limit a cancer cell’s ability to repair itself and leads to the death of cancer cells. To be eligible for this trial, patients with mCRPC must have failed to respond to either abiraterone acetate or enzalutamide (but not both) and to chemotherapy. 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/NCT03834519

ClinicalTrials.gov Identifier: NCT03834519


Additional open trials can be found by going to:

PCF

PCF

PCF


Literature:

PCFCancer 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 »

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