LUGPA Endorses AACU Policy Statement on Genomic Testing

Chicago, March 7, 2018—The National Comprehensive Cancer Network (NCCN) guidelines for Prostate Cancer version 1.2018, incorporate a position statement on genomic testing in prostate cancer. The position statement was proposed by the American Association of Clinical Urologists (AACU) and endorsed by LUGPA. The following statement can be attributed to Neal D. Shore, MD, FACS, president of LUGPA:

LUGPA is honored to support and formally endorse the AACU’s position regarding NCCN’s newly updated prostate cancer guidelines on genomic testing. LUGPA and AACU are proud to represent more than 6,000 American urologists who strive to provide patients with quality, personalized care. Together our organizations are sending a message to policy makers, researchers, payers, and most importantly, patients and their families, that we are committed to applying the best and most current science to the detection, risk stratification, and appropriate treatment of prostate cancer.

The role genomic testing plays in the treatment of prostate cancer is invaluable and increasingly yielding excellent patient outcomes. We are proud to support ongoing research to refine the prognostic power of genomic testing for prostate cancer, and strongly encourage patients to take their family histories into account when seeking medical treatment.

The following statement was originally released by the AACU and formally endorsed by LUGPA:

Advances in the laboratory increasingly provide clinicians with patient-specific genomic information that contributes to individualized risk-stratification, treatment planning, and assessment of hereditary cancer risk.

In prostate cancer, three different tissue-based molecular tests are available for use in risk stratification. Each is unique in the panel of genes tested, as well as the clinical endpoints for which they have been validated. There are also tests available to assess for inherited gene mutations (germline mutations) that have been shown to affect both personal and family risk of prostate and other cancers.

 The NCCN Prostate Cancer Guideline version 1.2018 makes recommendations for groups of prostate cancer patients that should consider tissue-based molecular testing and/or germline testing. It states:

• Tissue-based molecular testing should be considered for low and favorable intermediate risk men with life expectancy ≥ 10 years.
• Germline testing should be considered in men with very-low risk, low risk, favorable and unfavorable intermediate risk prostate cancer and strong family history. Germline testing should also be considered, irrespective of family history, in men with high-risk, very-high risk, regional or metastatic disease.
• Strong family history consists of: brother or father or multiple family members diagnosed with prostate cancer at less than 60 years of age; known germline DNA repair gene abnormalities, especially BRCA2 mutation or Lynch syndrome (germline mutations in MLH1, MSH2, MSH6, or PMS2); and/or more than one relative with breast, ovarian, or pancreatic cancer (suggests possibility of BRCA2mutation) or colorectal, endometrial, gastric, ovarian, pancreatic, small bowel, urothelial, kidney, or bile duct cancer (suggests possibility of Lynch syndrome).

There is an urgency to incorporating newly available laboratory tools into the evaluation and management of prostate cancer to promote the accurate selection of men for active surveillance and to identify those who may be better served with multimodal treatment rather than monotherapy. Better patient selection for active surveillance will reduce the burden of over-treatment of indolent disease. Further, it is incumbent on urologists to obtain detailed family cancer histories and to consider hereditary genetic testing when family history patterns suggest risk. It is estimated that we are aware of only 15% of BRCA mutation carriers in the United States. Identifying a man with a BRCA mutation may inform 1) his risk of developing prostate cancer, 2) the clinical course of his diagnosed prostate cancer, 3) his prostate cancer’s response to certain therapies, and 4) his family members’ risk of developing certain cancers.

While the available prostate cancer tissue-based molecular tests have robust retrospective scientific and clinical validity, they should be incorporated with other measures of prostate cancer risk including prostate-specific antigen, Gleason grade and clinical stage.

The AACU supports the use of tissue-based molecular testing as a component of risk stratification in prostate cancer treatment decision making. We also strongly encourage taking family cancer histories and pursuing germline testing where appropriate to provide patients and their families with clarity about their hereditary cancer risk. We also support ongoing research to further refine the prognostic power of these tests.