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

NCT02723734 | Active Not Recruiting

• 1 other identifier: MCC-18523
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 3

Brief 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). 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.

Conditions

Prostate Cancer

Keywords

Decipher®; African-American men; prostate; low risk PCa; intermediate risk PCa; genomic classifier (GC)

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 24 months

Study Arms (2)

African-American Men (AAM)

AAM with low risk or intermediate risk prostate cancer (PCa). Decipher® testing and standard treatment.

Other: Decipher® Testing

Non-African American Men (NAAM)

NAAM with low risk or intermediate risk prostate cancer (PCa). Decipher® testing and standard treatment.

Other: Decipher® Testing

Interventions

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.

Also known as: Genomic Classifier (GC) test

African-American Men (AAM); Non-African American Men (NAAM)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men diagnosed with localized prostate cancer.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (3)

Bay Pines VA Health care System

Bay Pines, Florida, 33744, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

James A. Haley VA Hospital

Tampa, Florida, 33612, United States

Location

Related Publications (2)

• 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.

  PMID: 36053178 RESULT

• Yamoah 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.

  PMID: 41671436 DERIVED

Related Links

• Moffitt Cancer Center Clinical Trials website

Biospecimen

Retention: SAMPLES WITH DNA

One PCa biopsy specimen (collected at baseline for all participants). One PCa RP specimen (only for those participants that select surgery). Blood Specimen (collected at baseline for all participants if they agree to participate in blood draw).

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Kosj Yamoah, M.D., Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 30, 2016
• Study Start: April 13, 2016
• Primary Completion: July 6, 2023
• Study Completion (Estimated): September 22, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

US (3)