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Clinical Trials

clinical trial brochureA clinical trial is a research study that involves people. The studies are an investigation of an experimental treatment to see if it is safe to use and effective in fighting the disease. Patients may consider enrolling in a clinical trial to gain access to experimental new therapies or techniques that are still in the investigational stage. Most treatments we use today for prostate cancer are the results of past clinical trials. Download ZERO’s free brochure providing an in-depth look at all aspects of clinical trials.

Many times people do not participate in a clinical trial because they did not know they were eligible or that one is available. It is important to ask and learn about clinical trials when you are making a treatment decision, as one may be an option for you.

Participating in a clinical trial is a way to gain access to promising and perhaps effective drugs yet to be approved by the FDA. Hundreds of research projects are currently investigating the potential of new drugs and new combinations of drugs. Clinical trials also test whether a new treatment is better at treating the cancer than the best treatment available today. The best treatment available today is known as the ‘standard of care’.

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Information about clinical trials was the most needed education topic by patients, survivors, and caregivers who participated in the ZERO education survey and had been living with the disease for some time.

Clinical trials follow strict guidelines and are highly controlled and regulated to provide the best protection to participants. A clinical trial consists of at least two groups depending upon the study protocol. A study protocol is a plan that describes the schedule of tests, procedures, medications and dosages, and the length of the study. One group of patients will receive the experimental drug or treatment and the other group of patients will receive either the standard of care or a placebo which has no therapeutic value. However placebos are almost never used in cancer treatment trials.

Click the links below to learn more about other aspects of clinical trials.

Regardless of which group they are in, all patients receive the same level of medical attention and care. In most clinical trials, the health of the participants is monitored both during and after the study period. The government, study sponsors and outside groups monitor results throughout the trial. They are typically sponsored by the federal government, pharmaceutical or biotech companies, medical institutions, or private foundations. Many clinical trials are successful in finding promising new treatments for prostate cancer, such as the ALSYMPCA trial described by Dr. Alicia Morgans in the video below.

Clinical trials have helped hundreds of thousands of people – who are alive today – because new, more effective treatments became available. It’s important to take charge of your health and educate yourself about clinical trials. A survey of 2,000 cancer survivors conducted by the Coalition of Cancer Cooperative Groups and Northwestern University in 2006 found only 12 percent of men were aware of prostate cancer clinical trials while being treated for the disease.

Finding a Clinical Trial

Talking to your health care team about available clinical trails is a good first step. In addition, there are trusted resources available to help you find a clinical trial.

You can call the National Cancer Institute’s (NCI) help line at 800-4-CANCER to help search the national databases for trial information. The NCI also maintains an online listing of cancer clinical trials at www.cancer.gov/clinicaltrials/search.

The National Institutes of Health maintains ClinicalTrials.gov which is a database of publicly and privately supported clinical studies.

These and other available databases allow you to conduct a very detailed search of all cancer clinical trials. The NCI’s and ClinicalTrials.gov listings are the most complete lists of cancer clinical trials available.

There are many clinical studies offered for patients with metastatic prostate cancer. These studies try to find out if study medications (alone or with other treatments) are safe and if they can help prevent, find, or treat prostate cancer. See if any of these studies conducted by Merck may be right for you.

Current Trials

While there are hundreds of clinical trials available for prostate cancer, below are some trials that are currently recruiting participants.

Early Stage Prostate Cancer

Locally Advanced Prostate Cancer

  • ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer (PrTK03) (NCT01436968)
    • The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in combination with radiation therapy for patients with intermediate-high risk localized prostate cancer. ProstAtak kills tumor cells and stimulates a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body’s immune system to detect and destroy cancer cells. Click here for more information about this trial sponsored by Advantagene, Inc.

Advanced Prostate Cancer

  • A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer (NCT04100018) 
    • The CA209-7DX study is testing the drug nivolumab in combination with docetaxel (the current standard of care drug) compared to placebo in combination with docetaxel in participants with metastatic castration-resistant prostate cancer (mCRPC). “Metastatic” means the cancer has spread beyond the prostate to other parts of the body. “Castration-resistant” means that the cancer no longer responds to treatments that lower testosterone. In this study, researchers will compare efficacy (as measured by radiographic progression-free survival and overall survival) and safety of nivolumab plus docetaxel versus placebo plus standard of care docetaxel. Click here for more information about this trial sponsored by Bristol Myers Squibb.
  • A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (AMPLITUDE) (NCT04497844)
    • The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS). Click here for more information about this trial sponsored by Janssen.
  • A Study of Rucaparib Versus Physician’s Choice of Therapy in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency (TRITON3) (NCT02975934)
  • Efficacy and Safety of Pembrolizumab Plus Enzalutamide Plus Androgen Deprivation Therapy Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (NCT04191096)
  • P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (NCT04249947)
  •  Study of Nivolumab Plus Ipilimumab, Ipilimumab or Cabazitaxel in Men With Metastatic  Prostate Cancer (NCT02985957)
    • The CA209-650 study is the continuation of a Phase 2, open-label clinical study for men diagnosed with metastatic castration-resistant prostate cancer (mCRPC). “Metastatic” means the cancer has spread beyond the prostate to other parts of the body. “Castration-resistant” means that the cancer no longer responds to treatments that lower testosterone. “Open label” means you will know which study drug or drugs you are taking. The purpose of this study is to test different doses of nivolumab and ipilimumab, ipilimumab alone, and cabazitaxel. The study team wants to learn more about which therapy is most effective in treating metastatic prostate cancer.  Click here for more information about this trial sponsored by Bristol Myers Squibb.
  • Study of Pembrolizumab Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (NCT03834506)
  • Study of Pembrolizumab Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (NCT03834493)
  • Study of Pembrolizumab Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (NCT03834519)

Side Effect Management

For Veterans

  • 18F-DCFPyL PET/CT Impact on Treatment Strategies for Patients With Prostate Cancer (PROSPYL) (NCT04390880)
    • The main purpose of this phase II trial study is to determine whether a positron emission tomography (PET)/computed tomography (CT) scan using 18F-DCFPyL affects the clinical management plan in Veterans. In this study, the management plan prior to and after 18F-DCFPyL PET/CT will be recorded by specific questionnaires and corresponding changes in management will be analyzed. The scan will be used to see how the disease has spread. Both the treatment strategies and probable disease outcomes as relevant to clinical endpoints will be assessed. This study is open to Veterans only. Click here to learn more about this study sponsored by the VA Greater Los Angeles Healthcare System.

Clinical Trials Webinar

2015-EDU-WEB-WebinarsAre you considering a clinical trial? How safe are clinical trials? How do you know if your clinical trial is working? The webinar, hosted by ZERO in partnership with Us TOO and OncoGenex features Dr. Tomasz Beer, Deputy Director at the Oregon Health & Science University. Dr. Beer covers everything you need to know about clinical trials.