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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02723734




Registration number
NCT02723734
Ethics application status
Date submitted
15/03/2016
Date registered
30/03/2016
Date last updated
1/10/2024

Titles & IDs
Public title
Validation Study on the Impact of Decipher® Testing - VANDAAM Study
Scientific 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)
Secondary ID [1] 0 0
MCC-18523
Universal Trial Number (UTN)
Trial acronym
VANDAAM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Decipher® Testing

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

Non-African American Men (NAAM) - NAAM with low risk or intermediate risk prostate cancer (PCa). Decipher® testing and standard treatment.


Other 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 code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Two Year Prostatic Specific Antigen (PSA) Failure Rate
Timepoint [1] 0 0
Up to 24 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/10/2024
Actual
Sample size
Target
Accrual to date
Final
240
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida

Funding & Sponsors
Primary sponsor type
Other
Name
H. Lee Moffitt Cancer Center and Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02723734
Trial related presentations / 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.
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Kosj Yamoah, M.D., Ph.D.
Address 0 0
H. Lee Moffitt Cancer Center and Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02723734