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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Bay Pines VA Health care System, Bay Pines, Florida, United States

About this 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Decipher® Testing

Other

Decipher® Prostate Cancer Classifier (Post-Op and Biopsy), a Genomic Classifier (GC) test. Biopsy and prostatectomy specimens will be collected for GC testing.

Other names: Genomic Classifier (GC) test

Primary outcomes

Two Year Prostatic Specific Antigen (PSA) Failure Rate

Time frame: Up to 24 months

PSA failure defined for first line treatment options of Radical Prostatectomy (RP) and Radiotherapy (RT) in accordance with National Comprehensive Cancer Network (NCCN) guidelines: PSA failure for RP is defined by an undetectable PSA after surgery with a subsequent detectable PSA that increases on 2 or more determinations (PSA recurrence); or failure of PSA to fall to undetectable levels (PSA persistence). PSA failure for treatment with RT is defined as PSA increase by 2 ng/mL or more above the nadir PSA.

To estimate the performance of genomic classifier (GC) in predicting 2-yr PSA failure rate, the area under curve (AUC) of a standard Receiver Operating Characteristic (ROC) curve will be calculated with corresponding 95% confidence intervals using resampling methods. In addition, positive and negative predictive probabilities, sensitivity, specificity and accuracy and associated 95% confidence intervals will also be calculated using predefined cut-points of 0.45 and 0.60.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Official study title

A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men With Prostate Cancer (VANDAAM Study)

Acronym: VANDAAM

Important dates

Study start: 2016
Primary completion: 2023
Study completion: 2026
First posted: Mar 30, 2016
Registry last updated: Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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