A 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’.
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.
- Types of Trials
- Clinical Trial Phases
- Informed Consent and Patient Protection
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.
While there are hundreds of clinical trials available for prostate cancer, below are some trials that are currently recruiting participants.
- 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.
- 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
- TRITON2 Rucaparib Trial
- Clovis Oncology is conducting a phase 2 clinical trial exploring rucaparib, a new potential treatment. Rucaparib is an oral tablet that has been shown to kill cancer cells with certain genetic mutations or alterations, and the purpose of this study is to determine the impact of rucaparib on metastatic prostate cancer that has worsened despite having received treatment with chemotherapy and hormonal therapy. Download a brochure with details about the study. Or visit the study’s website to find out more about the TRITON2 study.
- The purpose of this study is to assess the safety and efficacy of nivolumab in combination with rucaparib, docetaxel, or enzalutamide in participants with castration-resistant prostate cancer that has spread. Click here to visit the sponsor website.
- 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
- This trial is for men who are newly diagnosed with hormone sensitive metastatic prostate cancer and have a PSA level of at least 2ng/mL. All men in the study will receive standard androgen deprivation therapy (ADT), and one group will receive the experimental drug TAK-700 (orteronel) while the others will receive bicalutamide (Casodex). Click here for more information about this trial on clinicaltrials.gov. To visit the trial’s sponsor website, click here.
- 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.
- This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide. Click here for more information about this trial on clinicaltrials.gov.
- ARAMIS Trial
- The purpose of this study is to determine the safety and effectiveness of a new drug in delaying prostate cancer spreading from the prostate. This study is enrolling prostate cancer patients with rising PSA levels whose prostate cancer is at risk of progressing but has not already spread to other areas of the body. Click here for more information about this trial on clinicaltrials.gov. To visit the sponsor website, click here.
- VIABLE Study
- The purpose of this study is to determine whether DCVAC added onto Standard of Care Chemotherapy can improve survival times in patients with metastatic castration-resistant prostate cancer. Click here for more information about this trial on clinicaltrials.gov. To visit the sponsor website, click here.
- ATLAS Study
- The purpose of this study is to determine if a JNJ-56021927 plus GnRH agonist results in an improvement of metastasis-free survival in participants receiving primary radiation therapy. This trial is for patients with high-risk, localized or locally-advanced prostate cancer. Click here for more information about this trial on clinicaltrials.gov.
- EMBARK Study
- The purpose of this study is to assess the safety and efficacy of enzalutamide (Xtandi) plus leuprolide (Lupron) in patients with nonmetastatic prostate cancer. Candidates for this study have nonmetastatic cancer that is progressing after a radical prostatectomy, radiotherapy, or both. Click here for more information about this trial on clinicaltrials.gov. Click here to visit the sponsor website.
- 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
- The purpose of this study is to obtain information on the safety and effectiveness of the TULSA-PRO system, which is designed to destroy prostate tissue under MRI guidance using ultrasound energy. Candidates for this study are men ages 45 to 80 who have been diagnosed with early-stage, low- or intermediate-risk prostate cancer. Click here for more information about this trial on clinicaltrials.gov. Click here to visit the sponsor website.
- ENACT Trial
- The primary purpose of this study is to compare the time to prostate cancer progression (pathological or therapeutic progression) between patients treated with enzalutamide versus patients undergoing active surveillance. Click here for more information about this trial on clinicaltrials.gov.
- 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.
Clinical Trials Webinar
Are 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.