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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, it 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.

To be recruited for a clinical trial or survey, you can register for Research Match, a free program that connects people trying to find research studies with researchers looking for study participants.

Current Trials

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

  • Clinical Trial NCT02985957
    • The purpose of this study is to determine whether Nivolumab plus Ipilimumab has preliminary evidence of safety and effectiveness in the treatment of participants with metastatic castration-resistant prostate cancer who have progressed after prior Docetaxel-containing regimen. Click here for more information on BMS CS 209-650.
  • Clinical Trial NCT04100018
    • The purpose of this study is to test the safety and effectiveness of nivolumab with docetaxel in men with advanced castration resistant prostate cancer who have progressed after second-generation hormonal manipulation. Click here for more information on BMS CS 209-7DX.
  • Clinical Trial of P17-1 (PROVENT)  
    • The purpose of the ProVent trial is to assess the efficacy of immunotherapy (sipuleucel-T) in reducing disease progression of lower risk non-metastatic prostate cancer in men on Active Surveillance (AS). Click here for more information on the trial. 
  • Clinical Trial of MK7339-010 NCT
    • The purpose of this study is to assess the efficacy and safety of the combination of the polyadenosine 5′-diphosphoribose poly(ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone acetate or enzalutamide (but not both) and to chemotherapy. Click here for more information on the trial.
  • Clinical Trial of MK3475-921 NCT
    • The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA). Click here for more information on the trial.
  • Clinical Trial of MK3475-641 NCT
    • The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and enzalutamide in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC, are abiraterone-naïve, or are intolerant to or progressed on abiraterone acetate. Click here for more information on the trial.
  • Study of Phase II Laser Focal Therapy of Prostate Cancer (LITT or FLA)
    • The purpose of this research study is to continue to investigate the safety and effectiveness of using MR (magnetic resonance) guided laser focal therapy for prostate cancer and to evaluate oncologic control over 20 years. Click here for more information on the trial.
  • LUM Imaging Clinical Trial
    • Lumicell, a Boston-based biotechnology company, in collaboration with surgeons at academic medical centers through the United States has been developing a new technique to detect cancer cells during surgery. How it works: A luminescent agent is used in conjunction with a red light camera and decision software to detect residual cancer cells that can be removed in real-time in the operating room. The goal of this technology would be to reduce the need for second surgeries and potentially other therapies. The technology is late stage clinical trials for breast cancer (detecting cancer cells in-vivo in the lumpectomy cavity) and is now studying its use in prostate cancer (ex vivo – examining the margins of the prostate gland post-removal). For men diagnosed with prostate cancer interested in participating in this study, the Icahn School of Medicine at Mount Sinai in New York, NY is testing this technique for patients undergoing a radical prostatectomy. If you are interested in participating in this study click here:   https://clinicaltrials.gov/ct2/show/NCT03441464?term=lumicell&rank=5
  • ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer (PrTK03)
    • Advantagene is currently conducting a phase 3 clinical trial using Gene Mediated Cytotoxic Immunotherapy (GMCI) in intermediate and high-risk localized prostate cancer patients choosing radiation therapy. Prevention of prostate cancer recurrence in intermediate and high risk patients is the goal of Advantagene’s Phase 3 study. Successful development of GMCI for this indication will provide urologists with a new treatment option for their patients. Click here for more information on clinicaltrials.gov.
  • S1216 Trial
  • TALAPRO-1
    • The purpose of this international, phase 2, open-label, response rate study of talazoparib is to assess the efficacy and safety of talazoparib in men with DNA repair defects metastatic castration-resistant prostate cancer (CRPC) who previously received taxane-based chemotherapy and progressed on at least 1 novel hormonal agent (enzalutamide and/or abiraterone acetate/prednisone). Click here for more information about this trial on clinicaltrials.gov.
  • TALAPRO-2
  • ARAMIS Trial
  • ATLAS Study
  • EMBARK Study
  • TRITON3 Trial
    • The purpose of this trial is to determine the effectiveness of rucaparib (Rubraca) versus the physician’s choice of therapy in treating men with metastatic castration-resistant prostate cancer. Candidates for this study have metastatic castration-resistant prostate cancer as well as a BRCA1/2 or ATM gene mutation and have not been treated with chemotherapy at this stage. Click here for more information about this trial on clinicaltrials.gov.
  • TACT Trial
  • 68Ga-PSMA-R2 in Patients With Biochemical Relapse (BR) and Metastatic Prostate Cancer (mPCa) (PROfind)
    • Assessment of the safety and tolerability of a single administration of 3 mega Becquerel (MBq)/kg, but not less than 150 MBq and not more than 250 MBq, of 68Ga-PSMA-R2, to assess the pharmacokinetics (PK), biodistribution, and dosimetry of 68Ga-PSMA-R2, and to establish the optimal imaging method for determining location and burden of positive lesions in adult male patients with biochemical relapse (BR) and metastatic prostate cancer (mPCa). Click here for more information.
  • Study of HPN424 in Patients With Advanced Prostate Cancer
    • The purpose of this Phase 1 study of HPN424 as monotherapy is to assess the safety, tolerability and PK in patients with advanced prostate cancer refractory to androgen therapy. Click here for more information on the trial.
  • Merck trial NCT03834493
    • The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and enzalutamide in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC, are abiraterone-naïve, or are intolerant to or progressed on abiraterone acetate. More details here.
  • Merck trial NCT03834506
    • The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA). More details here.
  • Merck trial NCT04191096
    • This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus ADT versus placebo plus enzalutamide plus ADT in participants with mHSPC. More details here.
  • Merck trial NCT03834519
    • The purpose of this study is to assess the efficacy and safety of the combination of the polyadenosine 5′-diphosphoribose poly(ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone acetate or enzalutamide (but not both) and to chemotherapy. More details here.
  • Merck trial NCT02861573
    • The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in patients with metastatic castrate resistant prostate cancer (mCRPC). More details here.

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.