Frequently Asked Questions

PROMISE is an important new research study that brings precision medicine to the fight against prostate cancer. The study is a long-term collaboration between researchers, doctors, and patients to improve knowledge and understanding of the critical role of germline genetic mutations (inherited genes) in men with prostate cancer. (Precision medicine is an approach to tailoring disease prevention and treatment that takes into account differences in people’s genes, environments, and lifestyles, it can be contrasted with a “one size fits all” approach that focuses on an average person without consideration of individual differences)

PROMISE seeks to learn more about the role genes can play in improving outcomes for prostate cancer patients. Specifically, PROMISE research will examine how information about particular genetic profiles can:

• Influence the susceptibility of men to prostate cancer
• Impact the effectiveness of existing treatments
• Improve guidance for different and/or new treatment options
• suggest precise areas to explore for new discoveries.

The specific goal for this PROMISE research study is to show how specific inherited genetic factors or mutations (also called pathogenic variants in genes) of patients with prostate cancer can affect outcomes and/or treatment for those patients. A pathogenic variant is a genetic alteration that increases an individual’s susceptibility or predisposition to a certain disease or disorder such as cancer. When these variants (or mutations) are inherited, development of cancer may be more likely, but not certain.

To accomplish this, PROMISE will identify a group of patients with specific inherited genetic factors (i.e. inherited homologous recombination deficiency pathogenic variants) using a mouth swab DNA test. PROMISE will access each patient’s medical information via their physician every six months. PROMISE will also survey participating patients every six months about their treatment experience. This collective information will provide new insights that will help physicians and patients better understand germline genetic testing results. It will also create a new mechanism to communicate with a key group of prostate cancer patients on an ongoing basis to help connect them with new trials and treatments as germline genetic biomarker driven clinical trials are opened and approved for prostate cancer.

To be included in the PROMISE study, you must:

• Be 18 years of age or older, assigned male at birth
• Live in the US (including Puerto Rico, Guam, American Samoa, US Virgin Islands, Northern Mariana Islands).
• 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
• Clear radiographic evidence of disease
• Have at least one of the cancer risk genes the PROMISE study is researching.
• The DNA saliva test results will identify which patients have one or more of these genes. The test is free and will be sent when patients complete the registration process online.
• Prostate cancer patients who have already had genetic testing and their previous genetic test results show a genetic mutation in one of the genes, and meet all other criteria, are eligible to participate in the PROMISE study.

The patient and his physician are notified and receive a summary of the genetic test results.

A licensed genetic counselor provided by PROMISE will discuss the results and any implications for the patient and his family. The free appointment with the genetic counselor can be made online at the PROMISE registry.

The patient will also be asked to continue to the surveys and medical records follow-up.

• PROMISE is designed to be simple and easy for patients and their physicians. Patients don’t have to leave their home or the care of their physician.
• Patients answer a few questions online to see if they might be eligible for the study. If eligible, patients will fill out a consent form and some information about their demographics, health, and family history.
• We’ll ship a DNA saliva test to the patient’s home with instructions. It will only take about 5 minutes to do the DNA saliva test.
• After sending back the DNA saliva test with our pre-paid label, we will send the patient’s genetic testing results.
• Patients who have a mutation in at least one of the genes tested will be invited to continue participating in PROMISE through online surveys every 6 months. We will also ask patients’ doctors for updated medical records for information on their treatment and care.
• Patients can choose to leave PROMISE at any time. PROMISE is designed to continue for at least 20 years.

Prostate cancer patients who join PROMISE receive benefits in three key areas:

1. Learn important new information about genetic factors in their cancer.
   • In the fight against prostate cancer, information is the most powerful tool.
   • Discover if they have a critical gene mutation that may impact their personalized care plan
   • Receive the most current information about new research, clinical trial opportunities, and treatments approved by the FDA. This information is sent via regular newsletters and updates.

2. Help family members understand their own risk of prostate cancer as well as other types of cancer and disease.
   
   • Provide family members with updated information about susceptibility to cancer for themselves and future generations
   • Understand the effectiveness of different treatment options for their particular genetic profile

3. Join a select group of patients, physicians, and researchers making an essential contribution to advancing research & understanding of prostate cancer
   • Provide essential genetic information and long-term outcomes that are not available anywhere else.
   • Join a community of men and their families with the shared knowledge and experience of fighting prostate cancer

There are 4 million men living with prostate cancer – PROMISE can help save and improve their lives.

Prostate cancer is the second most common cancer in the US (after skin cancer). More than 32,000 men die from it each year. Some populations are at even more risk. As men get older they are exponentially more likely to be diagnosed with the disease. African American men are 76% more likely to develop it and are more than 2x more likely to die from it. The knowledge and insights that researchers will learn from PROMISE – i.e., from studying prostate cancer patients with germline pathogenic variants may help accelerate development of molecularly-targeted treatments and therapeutic strategies that may be used to treat patients prior to developing more advanced disease states. PROMISE can also help clinical trial matching by enabling trials to more rapidly identify eligible men even if those men constitute only 1% or 2% of all prostate cancer patients. Evidence shows that patients who participate in their first clinical trials are very likely to agree to participate in subsequent studies. Because PROMISE is not a therapeutic trial and does not require patients to leave their current treatment team, it can help expand the patient population willing to engage in clinical trials.

As a first step, patients should talk with their physicians about joining PROMISE. Once they’ve decided, patients register online at prostatecancerpromise.org by clicking “Join Us”.

Patients will fill out a few questions online to see if they are eligible for the study. If eligible, they will complete the informed consent process. PROMISE will then mail a simple home-based DNA saliva test. Patients return the saliva sample via US mail.

We anticipate that about 10% of those who submit their DNA test will have the specific genetic mutations that will be studied – and will therefore be asked to continue to the surveys and medical records follow-up.

PROMISE is completely free for patients. There is no cost for the at-home DNA test, genetic counselor appointment, and the newsletter updates.

All participants must complete an informed consent process before joining PROMISE. Disclosure, voluntariness, and decisional capacity make up the core of valid informed consent processes. Patients can choose to leave PROMISE at any time.

The PROMISE research study does not include clinical trials. PROMISE participants may receive information about available treatments and clinical trials through education resources and newsletters.

PROMISE research study does not provide new treatments to patients who join. PROMISE participants will receive information about available treatments and clinical trials through education resources and newsletters. For patients who are found to have actionable results for which there is an FDA approved drug, PROMISE will work with their treatment provider to recommend that medication at the appropriate time.

500 qualified participants are required for the research – 400 of those with germline pathogenic and likely pathogenic variants and 100 with germline variants of uncertain significance. We estimate that 5,000 men with prostate cancer will need to be screened to reach that goal.

PROMISE is designed to continue for at least 20 years (five years of accrual and 15+ years of follow-up), a period long enough to anticipate the emergence of trials that test pathogenic variants targeted treatments in biochemically recurrent prostate cancer patients and even earlier in the natural history of the disease.

Promise is led by Dr. Heather Cheng, M.D., Ph.D. at the University of Washington and Dr. Channing Paller, M.D. at Johns Hopkins University. Their work seeks to better understand and elucidate the role of germline mutations in modulating the effectiveness of prostate cancer treatments and sequences of treatments over time.

PROMISE also includes essential input and contributions from the Prostate Cancer Clinical Trials Consortium, genetic counselors and other health care providers working to improve the lives of prostate cancer patients.

Color is providing the DNA testing and genetic counseling services for PROMISE.

 Funding and support is provided by Advancing Cancer Treatment (ACT) a philanthropic organization whose mission is to work with physicians, patients, researchers and community organizations to help advance precision medicine and expand access to clinical trials that best meet each patient’s unique, individual treatment needs.

Popular DNA tests that are offered direct to consumers (DTC) such as 23andMe and ancestry.com, are not true medical tests. Results from these tests can be easily misconstrued and create false reassurances in patients who may have legitimate health risks. DTC tests can bypass the essential relationship between a doctor and patient. According to the FDA, these tests “should not be used as a substitute for seeing your doctor for cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease cancer risk.” DTC tests can produce false positives or false negatives. The FDA states,“Results obtained from the tests should not be used for diagnosis or to inform treatment decisions. Users should consult a healthcare professional with questions or concerns about results.” DTC tests can not be a replacement for licensed medical advice or screening which can only be obtained with certified genetic health risk (GHR) tests. PROMISE DNA testing is a certified genetic health risk test, is directed by physicians, and includes licensed genetic counseling.

Yes, Prostate cancer patients who have already had genetic testing and their previous genetic test results show a genetic mutation in one of the genes, and meet all other criteria, are eligible to participate in the PROMISE study.

Yes, anyone who meets the eligibility requirements, including family members, can join PROMISE.

Yes, while their information will not be included in the research process, patients who don’t have one of the 30 genes being studied, will still receive information via newsletters that will include updates on clinical trials, new treatment options, and updates on the PROMISE research.

Patients who join PROMISE will not be paid for their participation.

PROMISE provides germline testing. Germline testing, also called DNA testing or genetic testing, identifies gene mutations that are inherited. This testing provides information about inherited cancer risk and potential cancer treatments. Germline testing can also help family members understand their cancer risk and take proactive steps for their health.

PROMISE does not provide somatic testing. Somatic testing identifies gene mutations that are not inherited. Somatic testing is done to help find the best medication or treatment for an individual tumor or cancer. Somatic testing does not provide information about inherited risk for family members.

If the patient’s DNA testing reveals any genetic mutations, the PROMISE study team will reach out to their doctor every 6 months for medical records to follow up on any updates to the patient’s treatment and care.

PROMISE is collecting this information to learn about outcomes for prostate cancer patients with certain mutations. What we learn will help develop recommendations for prostate cancer patients in the future.

We will be using Color’s Hereditary Cancer test for PROMISE. This will test for genes linked to the most common hereditary cancers.

The genes that will be tested for are: APC, ATM, BAP1, BARD1, BMPR1A, BRCA1, BRCA2, BRIP1, CDH1, CDK4, CDKN2A, CHEK2, EPCAM, GREM1, MITF, MLH1, MSH2, MSH6, MUTYH, PALB2, PMS2, POLD1, POLE, PTEN, RAD51C, RAD51D, SMAD4, STK11, TP53

Results are typically available on the Color portal in 6-7 weeks, once patients mail back their DNA test kit using our pre-paid label.

The Genetic Information Nondiscrimination Act of 2008 (GINA) is a federal law that protects individuals from genetic discrimination in health insurance and employment.

Your health insurance and your employer cannot discriminate based on genetic information.

For some people, there may be other insurance considerations, beyond health and employment – so it’s best to discuss it with your physician and the social services resources at your healthcare provider.

Patient data will only be used for research by the PROMISE study team.

Patient data used in the PROMISE research is anonymized for analysis. Data cannot be traced back to any individual patient. All of our secure databases are password-protected and follow federal regulations on data security.