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

February 26, 2026 updated by: H. Lee Moffitt Cancer Center and Research Institute

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Observational

Enrollment (Actual)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Bay Pines, Florida, United States, 33744
        • Bay Pines VA Health care System
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute
      • Tampa, Florida, United States, 33612
        • James A. Haley VA Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Men diagnosed with localized prostate cancer.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
African-American Men (AAM)
AAM with low risk or intermediate risk prostate cancer (PCa). Decipher® testing and standard treatment.
Other: Decipher® Testing
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
Non-African American Men (NAAM)
NAAM with low risk or intermediate risk prostate cancer (PCa). Decipher® testing and standard treatment.
Other: Decipher® Testing
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Investigators

  • Principal Investigator: Kosj Yamoah, M.D., Ph.D., H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2016

Primary Completion (Actual)

July 6, 2023

Study Completion (Estimated)

September 22, 2026

Study Registration Dates

First Submitted

March 15, 2016

First Submitted That Met QC Criteria

March 24, 2016

First Posted (Estimated)

March 30, 2016

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-18523

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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