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

NCT ID: NCT02723734

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-13
• Study Completion Date: 2026-09-30

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

African-American Men (AAM)

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

Decipher® Testing

Intervention Type: OTHER

Decipher® Prostate Cancer Classifier (Post-Op and Biopsy), a Genomic Classifier (GC) test. Biopsy and prostatectomy specimens will be collected for GC testing.

Non-African American Men (NAAM)

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

Decipher® Testing

Intervention Type: OTHER

Decipher® Prostate Cancer Classifier (Post-Op and Biopsy), a Genomic Classifier (GC) test. Biopsy and prostatectomy specimens will be collected for GC testing.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Genomic Classifier (GC) test

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kosj Yamoah, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

Bay Pines VA Health care System

Bay Pines, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

James A. Haley VA Hospital

Tampa, Florida, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 36053178 (View on PubMed)

Related Links

https://moffitt.org/clinical-trials-research/

Moffitt Cancer Center Clinical Trials website

Other Identifiers

MCC-18523

Identifier Type: -

Identifier Source: org_study_id