In The Fight Against Prostate Cancer, Your DNA May Be The Most Powerful Tool

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. The PROMISE Registry team recommends that you share results with your healthcare provider, no matter what those results may be. For instructions on how to share results with your provider, please visit our How it Works page.

• 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.