This Contractor will provide limited coverage for the ProMark (Metamark
Genetics) to help determine which patients with early stage, needle biopsy
proven prostate cancer can be conservatively managed rather than treated with
definitive surgery or radiation therapy.

Level of Evidence

Quality - Limited to Moderate  
Strength - Limited to Moderate  
Weight - Limited

**Criteria for Coverage**

The ProMark assay is covered 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 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 prostectomy, radiation therapy or brachytherapy), **and**
  * Patient has not received pelvic radiation or androgen deprivation therapy prior to the biopsy, **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.

**Certification and Training Registry (CTR) Program**

Because of the complicated nature of management decisions utilizing the
ProMark assay and the potential for adverse harm to patients if the test is
not used appropriately, testing must be furnished only by physicians who are
enrolled in a Molecular Diagnostic Services Program (MolDX) approved ProMark
CTR program. This serves to assure the appropriate selection of patients,
compliance with management decisions and stringent follow up to ensure the
benefits of the test outweigh its risks. As part of this requirement Metamark
will provide to the Contractor reports every 6 months in a mutually agreed
upon format.

The goals of the Metamark Genetics ProMark CTR program are as follows:

  * To ensure that physicians understand the limitations of the test based on its validation, **and**
  * To inform prescribers and patients on the safe-use conditions for ProMark assay, **and**
  * To make a good faith effort to identify any safety concerns from the use of the test, **and**
  * To facilitate understanding of the incremental clinical utility of the test versus adherence to current NCCN guidelines

This Contractor expects Metamark Genetics to:

  * Establish and maintain the ProMark Certification and Training Registry (CTR);
  * Ensure that healthcare providers who order the ProMark assay are registered and certified in the ProMark CTR program and that the ProMark assay is available only through these providers;
  * Maintain a secure registry database of Metamark's ProMark CTR providers and obtain from referring physicians;  

    * NCCN risk group and treatment recommendation based on current NCCN guidelines prior to receipt of test result;
    * Test result (i.e., ProMark Risk Score), and  

      * Treatment recommendation based on test results, and
      * Final physician-patient treatment decision, and
      * Report utilization data by clinic-pathologic staging;
      * Any subsequent change in patient treatment decision, even if the patient has not progressed, and
      * Immediately report (for patients not treated definitively who were deemed very low or low risk by the assay)  

        * Progression as defined by current NCCN guidelines for patients on AS, or
        * Development of metastases, or
        * Prostate cancer deaths.
  * Share all required data and reports in a HIPAA complaint fashion.