Prostate CancerVANDAAMNCT02723734
Validation Study on the Impact of Decipher® Testing - VANDAAM Study
An observational study of Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 3 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Decipher® Testing
- How many people
- 240 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Apr 2016to 22 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men diagnosed with localized prostate cancer.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Bay Pines VA Health care System
Bay Pines, Florida, 33744
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
James A. Haley VA Hospital
Tampa, Florida, 33612
About this study
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)
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.
Read the 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).
- Conditions
- Prostate Cancer
- Being tested
- Decipher® Testing
- Keywords
- Decipher®, African-American men, prostate, low risk PCa, intermediate risk PCa, genomic classifier (GC)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decipher® TestingOther
Also called Genomic Classifier (GC) test
Decipher® Prostate Cancer Classifier (Post-Op and Biopsy), a Genomic Classifier (GC) test. Biopsy and prostatectomy specimens will be collected for GC testing.
| Study group | Role | What they receive |
|---|---|---|
| African-American Men (AAM) | AAM with low risk or intermediate risk prostate cancer (PCa). Decipher® testing and standard treatment. Receives: Other: Decipher® Testing | |
| Non-African American Men (NAAM) | NAAM with low risk or intermediate risk prostate cancer (PCa). Decipher® testing and standard treatment. Receives: Other: Decipher® Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two Year Prostatic Specific Antigen (PSA) Failure Rate
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.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study start13 Apr 2016
- Primary completion6 Jul 2023
- Study completion22 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kosj Yamoah, M.D., Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723734
- Sponsor's protocol ID
- MCC-18523
- Acronym
- VANDAAM
- Status last verified
- Feb 2026
- First submitted
- 15 Mar 2016
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Awasthi S, Grass GD, Torres-Roca J, Johnstone PAS, Pow-Sang J, Dhillon J, Park J, Rounbehler RJ, Davicioni E, Hakansson A, Liu Y, Fink AK, DeRenzis A, Creed JH, Poch M, Li R, Manley B, Fernandez D, Naghavi A, Gage K, Lu-Yao G, Katsoulakis E, Burri RJ, Leone A, Ercole CE, Palmer JD, Vapiwala N, Deville C, Rebbeck TR, Dicker AP, Kelly W, Yamoah K. Genomic Testing in Localized Prostate Cancer Can Identify Subsets of African Americans With Aggressive Disease. J Natl Cancer Inst. 2022 Dec 8;114(12):1656-1664. doi: 10.1093/jnci/djac162.
PubMed 36053178Yamoah K, Trivedi P, Awasthi S, Grass GD, Torres-Roca J, Johnstone PA, Dhillon J, Park JY, Davicioni E, Hakansson A, Liu Y, Fink AK, Katende E, Smith R, Putney R, Poch M, Li R, Manley B, Fernandez D, Gage K, Ferguson K, Lu-Yao G, Kim Y, Katsoulakis E, Leone A, Vapiwala N, Deville C, Rebbeck TR, Dicker AP, Kelly W, Yin V, Burri RJ, Ercole CE, Pow-Sang J. A Prospective Validation of the Decipher Genomic Classifier in Men With Early Localized Prostate Cancer: The VANDAAM Study. J Natl Compr Canc Netw. 2025 Dec 17;24(1):e257089. doi: 10.6004/jnccn.2025.7089.
PubMed 41671436
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02723734
- Acronym / sponsor ID
- VANDAAM / MCC-18523
- Conditions
- Prostate Cancer
- Keywords
- Decipher®, African-American men, prostate, low risk PCa, intermediate risk PCa, genomic classifier (GC)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 13 Apr 2016 (actual)
- Primary completion
- 6 Jul 2023 (actual)
- Study completion
- 22 Sep 2026 (estimated)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| African-American Men (AAM) | – | Other: Decipher® TestingAAM with low risk or intermediate risk prostate cancer (PCa). Decipher® testing and standard treatment. |
| Non-African American Men (NAAM) | – | Other: Decipher® TestingNAAM with low risk or intermediate risk prostate cancer (PCa). Decipher® testing and standard treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men diagnosed with localized prostate cancer.
Key inclusion criteria (7 listed)
- 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))
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decipher® TestingAlso: Genomic Classifier (GC) testDecipher® Prostate Cancer Classifier (Post-Op and Biopsy), a Genomic Classifier (GC) test. Biopsy and prostatectomy specimens will be collected for GC testing. | Other | African-American Men (AAM), Non-African American Men (NAAM) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Results publication: PubMed 36053178Awasthi S, Grass GD, Torres-Roca J, Johnstone PAS, Pow-Sang J, Dhillon J, Park J, Rounbehler RJ, Davicioni E, Hakansson A, Liu Y, Fink AK, DeRenzis A, Creed JH, Poch M, Li R, Manley B, Fernandez D, Naghavi A, Gage K, Lu-Yao G, Katsoulakis E, Burri RJ, Leone A, Ercole CE, Palmer JD, Vapiwala N, Deville C, Rebbeck TR, Dicker AP, Kelly W, Yamoah K. Genomic Testing in Localized Prostate Cancer Can Identify Subsets of African Americans With Aggressive Disease. J Natl Cancer Inst. 2022 Dec 8;114(12):1656-1664. doi: 10.1093/jnci/djac162.
- Derived from this study: PubMed 41671436Yamoah K, Trivedi P, Awasthi S, Grass GD, Torres-Roca J, Johnstone PA, Dhillon J, Park JY, Davicioni E, Hakansson A, Liu Y, Fink AK, Katende E, Smith R, Putney R, Poch M, Li R, Manley B, Fernandez D, Gage K, Ferguson K, Lu-Yao G, Kim Y, Katsoulakis E, Leone A, Vapiwala N, Deville C, Rebbeck TR, Dicker AP, Kelly W, Yin V, Burri RJ, Ercole CE, Pow-Sang J. A Prospective Validation of the Decipher Genomic Classifier in Men With Early Localized Prostate Cancer: The VANDAAM Study. J Natl Compr Canc Netw. 2025 Dec 17;24(1):e257089. doi: 10.6004/jnccn.2025.7089.
- Moffitt Cancer Center Clinical Trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kosj Yamoah, M.D., Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two Year Prostatic Specific Antigen (PSA) Failure Rate (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02723734, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.