PROMISE Registry: A Prostate Cancer Registry of Outcomes and Germline Mutations for Improved Survival and Treatment Effectiveness
Inherited genes may help you better understand your prostate cancer, discover new treatments, and determine whether your family is at increased risk. It is essential to learn more about how inherited genes relate to prostate cancer.
PROMISE is a nationwide registry study of prostate cancer patients with inherited gene mutations. The purpose of the PROMISE registry is to learn more about the role genes play in improving outcomes for prostate cancer patients. This clinical trial plans to screen approximately 5,000 men with a prostate cancer diagnosis. This registry study will help researchers better understand how genes:
- Increases a man's chances of getting prostate cancer
- Determine how well treatment will work
- Improve the management of prostate cancer treatment options.
- Help in the discovery of new treatment
WHAT IS A REGISTRY STUDY?
A registry study is an observational study used to collect uniform data to evaluate outcomes for a population defined by a disease or condition. PROMISE is a registry of prostate cancer patients with specific gene mutations.
- Taking a brief survey online, which contains questions about you and your family to determine eligibility
- Collecting a sample of your saliva, which should take only 5 minutes
- Returning your saliva sample to the laboratory using an enclosed pre-paid label.
- PROMISE is completely free for patients. There is no cost for the at-home DNA test, and genetic counselor appointment.
- Patients do not need to leave home and they remain under the care of their physician.
Those who participate should receive genetic test results in 6-8 weeks; once their genetic information is obtained, patients can make an appointment to review their results with a genetic counselor.
Those men with a genetic change in one of the 30 genes tested will be invited to continue participating in PROMISE through online surveys every six months. With the participant's approval, their doctor will be asked to provide information on the participant's treatment and care.
PROMISE will send patients newsletters that include updates on clinical trials, new treatment options, and updates on the PROMISE research.
WHO CAN PARTICIPATE?
- You may be able to participate in this study if you:
- Are 18 years of age or older.
- Have prostate cancer (any stage of the disease or survivorship) diagnosed or documented through one of the following:
- Tissue biopsy
- PSA greater than 100 ng/dl (1ng/ml)
- Clear radiographic evidence of disease
- Live in the United States (including Puerto Rico, Guam, American Samoa, US Virgin Islands)
- Patients are eligible whether they have had genetic testing or not.
POSSIBLE PATIENT BENEFITS:
- Gain valuable information about genetic factors in cancer and whether gene mutations may impact your care plan.
- May assist in better management of your type of prostate cancer.
- Help family members understand their own risk of cancer and risk for future generations.
POSSIBLE PATIENT RISKS:
- No risks associated with this diagnostic clinical trial.
TRIAL CONTACTS AND LOCATIONS:
- prostatecancerpromise.org; call 646-449-3363 (staffed M-F 9 AM-5 PM ET); or email email@example.com
- Trial sites can be found here. Note: patients do not need to leave home to participate.
ORGANIZATION: Prostate Cancer Clinical Trials Consortium (PCCTC)
CLINICALTRIALS.GOV IDENTIFIER: NCT04995198
Use the “clinical trials glossary” and “dictionary” for words, phrases, and treatments that you may not understand.
To Register and Learn More:
Text PHEN to #22828
PHEN Contact: 617-481-4020
Please Note: This information is provided for education and awareness purposes. A decision on clinical trials participation is to be made between the patient and his doctor.