Validation Study on the Impact of Decipher® Testing - VANDAAM Study

This is a multisite, prospective validation trial. Based on a population consisting of 25%
AAM and 75% NAAM, investigators will actively recruit participants and aim to achieve a 1:1
enrollment ratio of AAM to NAAM. To achieve this, low risk AAM will be accrued first and then
matching NAAM will be enrolled. NAAM men will be matched to AAM on prostate specific antigen
(PSA) at diagnosis.

There will be no treatment intervention beyond standard of care (SOC), and therefore
participants will be allowed to choose their definitive treatment option. The intent is to
enroll low risk and high volume disease (burden) patients to limit the accrual of patients
that would select active surveillance (AS).

Inclusion Criteria:

- Adult patients with Karnofsky Performance Status >70

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

- Pathologically (histologically) proven diagnosis of prostate cancer (PCa) undergoing
their first line of treatment

- Meet National Comprehensive Cancer Network (NCCN) criteria for either: Low risk PCa
(defined as Gleason score 6 in ≥ 3 cores; T-stage T1c- T2a); Intermediate risk PCa
(defined as Gleason score 7, or prostatic specific antigen (PSA) ≥ 10 ng/ml & < 20
ng/ml, or T-stage ≤ T2c)

- Eligible for either radical prostatectomy (RP) or definitive radiation therapy (RT)
(+/- short-term androgen deprivation therapy (ADT))

- Age > 18 years

- Biopsy specimen available

Exclusion Criteria:

- Inability to acquire biopsy or prostatectomy tissue

- History of prior PCa directed chemotherapy or pelvic irradiation (prior to study
enrollment)

- Documented distant metastatic disease or pelvic lymphadenopathy

- Prior radical prostatectomy (RP) or cryosurgery for prostate cancer or bilateral
orchiectomy

- Targeted for active surveillance after diagnostic biopsy

- Selecting ADT alone after diagnostic biopsy

- On active surveillance for > 6 months after diagnosis