Validation Study on the Impact of Decipher® Testing - VANDAAM Study (VANDAAM)
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ClinicalTrials.gov Identifier: NCT02723734 |
Recruitment Status :
Recruiting
First Posted : March 30, 2016
Last Update Posted : May 31, 2022
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Condition or disease | Intervention/treatment |
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Prostate Cancer | Other: Decipher® Testing |
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 |
Estimated Enrollment : | 250 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official 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) |
Actual Study Start Date : | April 13, 2016 |
Estimated Primary Completion Date : | April 30, 2023 |
Estimated Study Completion Date : | May 31, 2024 |

Group/Cohort | Intervention/treatment |
---|---|
African-American Men (AAM)
AAM with low risk or intermediate risk prostate cancer (PCa). Decipher® testing and standard treatment.
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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 Name: 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 Name: Genomic Classifier (GC) test |
- 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.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723734
Contact: Angelina Fink | 813-745-2588 | angelina.fink@moffitt.org | |
Contact: Angelina Fink | Fax: 813-449-6672 |
United States, Florida | |
Bay Pines VA Health care System | Recruiting |
Bay Pines, Florida, United States, 33744 | |
Contact: Lea Wescott 727-398-6661 ext 5772 lea.wescott@va.gov | |
Principal Investigator: Ryan Burri, MD | |
H. Lee Moffitt Cancer Center and Research Institute | Recruiting |
Tampa, Florida, United States, 33612 | |
Contact: Angelina Fink, MPH 813-745-2588 angelina.fink@moffitt.org | |
Contact: Kosj Yamoah, M.D., Ph.D. 813-745-4257 kosj.yamoah@moffitt.org | |
Principal Investigator: Kosj Yamoah, M.D., Ph.D. | |
James A. Haley VA Hospital | Active, not recruiting |
Tampa, Florida, United States, 33612 |
Principal Investigator: | Kosj Yamoah, M.D., Ph.D. | H. Lee Moffitt Cancer Center and Research Institute |
Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT02723734 |
Other Study ID Numbers: |
MCC-18523 |
First Posted: | March 30, 2016 Key Record Dates |
Last Update Posted: | May 31, 2022 |
Last Verified: | May 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Decipher® African-American men prostate |
low risk PCa intermediate risk PCa genomic classifier (GC) |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |