NCT02723734Active, not recruiting
Validation Study on the Impact of Decipher® Testing - VANDAAM Study
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)
Source: ClinicalTrials.gov · Last updated 2 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 240 (actual)
- First submitted
- 15 Mar 2016
- Start date
- 13 Apr 2016
- Primary completion date
- 6 Jul 2023
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Diseases
- Prostate cancer
- NCT number
- NCT02723734
What you commit to
- Study type: Observational
- Participants enrolled: 240
- From 13 Apr 2016 to the primary completion date, 6 Jul 2023
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior PCa directed chemotherapy or pelvic irradiation (prior to study enrollment)
- Prior radical prostatectomy (RP) or cryosurgery for prostate cancer or bilateral orchiectomy
Other illness
- Documented distant metastatic disease or pelvic lymphadenopathy
Other
- Inability to acquire biopsy or prostatectomy tissue
- Targeted for active surveillance after diagnostic biopsy
- Selecting ADT alone after diagnostic biopsy
- On active surveillance for \> 6 months after diagnosis
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bay Pines VA Health care System Coordinator of this site? Confirm its status | Bay Pines | United States | Unknown status |
| James A. Haley VA Hospital Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| H Lee Moffitt Cancer Center and Research Institute Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.