Guideline Page and Request PROS-1 Submission from Myriad Genetic Laboratories, Inc. Request addition of recommendation for genetic risk assessment/testing to the Initial Clinical Assessment algorithm for newly diagnosed patients, with a footnote describing the existing NCCN Guidelines for assessment/testing (Genetic/Familial High- Risk Assessment: Breast and Ovarian.) PROS-1 Submission from Dean Troyer, MD of Eastern Virginia Medical School Recommend tumor PTEN status as a routine component of the diagnostic evaluation of prostate cancer. PROS-2, -3, -4, -5, and -7 Submission from Genome DX Biosciences Inc. PROS-2, -3, -4, -5: recommend adding the sentence The 22-marker genomic classifier assay can be considered in men with one or more adverse laboratory/pathologic features or biochemical recurrence to guide the use of treatment such as adjuvant or salvage radiotherapy after radical prostatectomy. as an additional footnote to term Adverse features next to footnote j. Panel Discussion/References Guideline at this time. Panel would like to see more data. PTEN is included in the table on MS-40 of the guidelines. Guideline at this time but will update the references. Lotan T, Wei W, Ludkovski O, et al. Analytic validation of a clinical-grade PTEN immunohistochemistry assay in prostate cancer by comparison to PTEN FISH. Mod Pathol. 2016 May 13. Doi: 10.1038/modpathol.2016.88. [Epub ahead of print] Tryoer DA, Jamaspishvili T, Wei W, et al. A multicenter study shows PTEN deletion is stronly associated with seminal vesicle involvement and extracapsular extension in localized prostate cancer. The Prostate 2015, 75(11):1206-15. Guideline at this time. Institution Vote YES NO ABSTAIN ABSENT
PROS-7 of NCCN V2.2016: recommend adding the sentence The 22-marker genomic classifier assay can be considered in men with one or more adverse laboratory/pathologic features or biochemical recurrence to guide the use of treatment such as adjuvant or salvage radiotherapy after radical prostatectomy. as a footnote to term Studies negative for distant metastases. PROS-8 PROS-B Submission from Medical Imaging & Technology Alliance (MITA) Request review of the use of PET/CT imaging with 11C-choline, FDG, 18FNaF, and fluciclovine F 18 in men with suspected prostate cancer biochemical recurrence and request update of recommended list of imaging techniques accordingly. PROS-B Submission from Blue Earth Diagnostics, Inc. Request the addition of fluciclovine F 18 to the list of imaging techniques recommended for detection of prostate cancer recurrence in men with biochemical recurrence (BCR). Guideline at this time. The Panel plans a thorough review of the relevant data in the near future with possible updated recommendations at that time. Guideline at this time. The Panel plans a thorough review of the relevant data in the near future with possible updated recommendations at that time. Submission from Astellas Pharma, Medical Affairs. Request review of data from the TERRAIN and STRIVE trials, which evaluated the use of enzalutamide compared to bicalutamide Based on Panel discussion and references noted below the Panel consensus is in favor of updating the guidelines with a bullet on PROS-F 3 of 4. Shore N, Chowdhury S, Villers A, et al. Efficacy and safety of enzalutamide versus bicalutamide for patients with metastatic prostate cancer (TERRAIN): a 19 0 0 7
in men with CRPC as described above; data from these trials have been published in Lancet Oncology (TERRAIN) and in the Journal of Clinical Oncology (STRIVE). PROS-F (1 of 4) Internal request: Include list of ADT agents to clarify/specify the indication. randomized, double-blind, phase 2 study. Lancet Oncol (Epub) 01-13-2016. Accessible online at: http://www.thelancet.com/pdfs/journals/lanonc/p)1s1470-2045(15)00518-5.pdf. Penson D, Armstrong A, Concepcion R, et al. Enzalutamide Versus Bicalutamide in Castration- Resistant Prostate Cancer: The STRIVE Trial. J Clin Oncol (Epub) 01-25-2016. Accessible online at: http://jco.ascopubs.org/content/early/2016/01/21/jco.2015.64.9 285.full.pdf+html. The following list was added to the Principles of Androgen Deprivation Therapy section: Androgen Deprivation Therapy (ADT) for clinically localized disease (PROS-2 through PROS-6), biochemical failure without metastases OR for metastatic castration-naïve disease (PROS- 8 through PROS-10): LHRH agonist alone o Goserelin o Histrelin o Leuprolide o Triptorelin LHRH agonist (as above) plus first-generation antiandrogen o LHRH agonist plus nilutamide o LHRH agonist plus flutamide o LHRH agonist plus bicalutamide LHRH agonist (as above) plus second-generation antiandrogen o LHRH agonist plus enzalutamide LHRH antagonist o Degarelix Secondary Hormone Therapy for M0 or M1 Castration- Recurrent Disease (PROS-11 through PROS-14): First-generation antiandrogen o Nilutamide o Flutamide o Bicalutamide Second-generation antiandrogen o Enzalutamide Ketoconazole 26 0 0 0
Ketoconazole plus hydrocortisone Corticosteroids (hydrocortisone, prednisone, dexamethasone) DES or other estrogen PROS-G Internal request: Include a list of systemic therapy for M1 castration-recurrent disease. NCCN Guidelines for Prostate Cancer with Evidence Blocks Submission from Astellas Pharma. Request the review and revision of ratings and category classifications for enzalutamide in the setting of systemic therapy for M1 castration-recurrent prostate cancer for patients with and without visceral metastases. Specifically request that the Systemic therapy for M1 castration-recurrent disease (PROS-12 through PROS-14): Second generation antiandrogen o Enzalutamide (category 1; category 2A if prior therapy with abiraterone) Androgen biosynthesis inhibitor o Abiraterone + prednisone (category 1; category 2A for initial treatment of disease with visceral metastases or if prior therapy with enzalutamide) Page 3 of 4 added Ketoconazole ± hydrocortisone should not be used if disease progressed on abiraterone. The following list was added to the Principles of Immunotherapy and Chemotherapy section: Systemic Therapy for M1 Castration-Recurrent Disease Chemotherapy o Docetaxel + prednisone (category 1; category 2A for rechallenge) o Cabazitaxel + prednisone (category 1 postdocetaxel) Immunotherapy o Sipuleucel-T (category 1) Only for asymptomatic or minimally symptomatic, no liver metastases, life expectancy >6 mo, ECOG performance status 0-1 Guideline at this time. 26 0 0 0
efficacy of the agent rating be reconsidered based on available data.