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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
Trial website
Trial related presentations / publications
Public notes

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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Awasthi S, Grass GD, Torres-Roca J, Johnstone PAS,... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT02723734