This is a protocol for a Cochrane Review (prognosis). The objectives are as follows:

To determine the prognostic value of the Decipher gene assay in men with biopsy-confirmed clinically localized prostate cancer before and after receiving treatment.

This objective can be framed in two questions following the population, index prognostic factor, comparator prognostic factor(s), outcome, timing, and setting (PICOTS) format as illustrated in Table 1.

Table 1. Review question in PICOTS format

Objective

Before treatment

After treatment

Population

Men with newly diagnosed, biopsy-confirmed clinically localized prostate cancer

Men who have undergone radical prostatectomy for clinically localized prostate cancer

Index prognostic factor

Decipher gene assay

Comparator

Existing clinical prediction models

Outcome

Overall survival and prostate-cancer survival

Timing

The outcome is to be predicted at any point after diagnosis

Setting

Before primary, local treatment with curative intent

Following primary surgical treatment with curative intent