Indications for Use

The ProMark assay is indicated for use in men diagnosed with NCCN Very-Low, NCCN Low, and NCCN Intermediate-risk prostate cancer who are considered candidates for active surveillance.

The NCCN guidelines describe several primary treatment options for clinically low risk Prostate Cancer patients. The choice of appropriate primary treatment for each patient should be informed by the patient's life expectancy and in assessment of that patient's risk of recurrence. Recurrence risk staging systems are recommended by the NCCN Guidelines. Risk staging evaluation is based on cliniocpathologic patient characteristics, such as tumor size, Gleason score, PSA levels, number of positive biopsy cores, proportion of cancer tissue in biopsy cores, and PSA density. Please see Table 1, below for an overview of the NCCN Risk classification parameters for Very-Low to Intermediate risk categories. The 2016 NCCN Guidelines now recognize tissue-based molecular assays, like ProMark, as an option to improve risk stratification for men with localized Prostate Cancer who have a life expectancy of >5 years.*


Table 1: NCCN™ - based risk categories for Prostate Cancer relevant to ProMark

Very Low Risk

T1c

And

Gleason Score = 6

And

PSA< 10ng /mL

And

Fewer than 3 prostate biopsy cores positive,

with = 50% cancer in each core

And

PSA density < 0.15 ng/mL/g

Low Risk

T1-T2a

And

Gleason Score ≤ 6

And

PSA < 10ng/mL

Intermediate Risk

T2b-T2c

Or

Gleason Score = 7

Or

PSA 10-20 ng/mL


Conditions for Coverage of Medicare Beneficiaries per LCD L36665:

The ProMark assay is covered for Medicare Beneficiaries only when the following clinical conditions are met:
  • Needle biopsy with localized adenocarcinoma of prostate (no clinical evidence of metastasis or lymph node involvement), and
  • Patient Stage as defined by the one of the following:
    • Very Low Risk Disease (T1c AND Gleason Score = 6 AND PSA = 10 ng/mL AND < 3 prostate cores with tumor AND = 50% cancer in any core AND PSA density of < 0.15 ng/mL/g) OR
    • Low Risk Disease (T1-T2a AND Gleason Score = 6 AND PSA = 10 ng/mL), and
  • Patient has an estimated life expectancy of greater than or equal to 10 years, and
  • Patient is a candidate for and is considering conservative therapy and yet and would be eligible for definitive therapy (radical prostatectomy, radiation therapy or brachytherapy), and
  • Patient has not received pelvic radiation or androgen deprivation therapy prior to the biopsy, and
  • Test is ordered by a physician certified in the Metamark Genetics Certification and Training Registry (CTR), and
  • Patient is monitored for disease progression according to active surveillance guidelines as recorded in NCCN guidelines, and
  • Physician must report the development of metastasis or Prostate Cancer deaths in patients not treated definitively who were deemed low risk by the assay.