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

Running, not enrolling

Conditions studied: Prostate Cancer

In brief

The primary purpose of this study is to determine whether a tumor test recently developed by GenomeDx Biosciences known as Decipher® can predict aggressive prostate cancer with the same accuracy in African-American men (AAM) as in non-African-American men (NAAM). The Decipher® test was developed from samples derived mainly from men of European origins and little is known about its performance in AAM. It is important to study whether this test can be used in AAM who are known to experience the highest rates of prostate cancer as well as death from prostate cancer. The use of the Decipher® test result to predict how well a patient will do before treatment may make it possible for doctors to distinguish aggressive disease from low risk prostate cancer and modify treatment accordingly. Thus, patients that do not need additional therapies may be spared from unnecessary side effects and those that are at risk may be provided with more aggressive therapy to improve survival. This study is being done to learn whether the Decipher test can really affect these outcomes.

Key facts

Study ID

NCT02723734

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

240

Starts

2016-04-13

Expected to finish

2026-09-22

Last updated by the study team

2026-03-02

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Bay Pines VA Health care System — Bay Pines, Florida, United States
• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• James A. Haley VA Hospital — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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