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

This study is currently recruiting participants.
Verified November 2017 by H. Lee Moffitt Cancer Center and Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02723734
First Posted: March 30, 2016
Last Update Posted: December 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
  Purpose
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.

Condition Intervention
Prostate Cancer Other: Decipher® Testing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • 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.



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).

Estimated Enrollment: 240
Actual Study Start Date: April 13, 2016
Estimated Study Completion Date: May 31, 2021
Estimated Primary Completion Date: April 30, 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
African-American Men (AAM)
AAM with low risk or intermediate risk prostate cancer (PCa). Decipher® testing and standard treatment.
Other: 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.
Other Name: Genomic Classifier (GC) test
Non-African American Men (NAAM)
NAAM with low risk or intermediate risk prostate cancer (PCa). Decipher® testing and standard treatment.
Other: 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.
Other Name: Genomic Classifier (GC) test

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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men diagnosed with localized prostate cancer.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723734


Contacts
Contact: Angelina Fink 813-745-2588 angelina.fink@moffitt.org
Contact: Angelina Fink Fax: 813-449-6672

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Angelina Fink, MPH    813-745-2588    angelina.fink@moffitt.org   
Contact: Kosj Yamoah, M.D., Ph.D.    813-745-4257    kosj.yamoah@moffitt.org   
Principal Investigator: Kosj Yamoah, M.D., Ph.D.         
James A. Haley VA Hospital Not yet recruiting
Tampa, Florida, United States, 33612
Principal Investigator: Raoul Salup, M.D.         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: Kosj Yamoah, M.D., Ph.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT02723734     History of Changes
Other Study ID Numbers: MCC-18523
First Submitted: March 15, 2016
First Posted: March 30, 2016
Last Update Posted: December 4, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Decipher®
African-American men
prostate
low risk PCa
intermediate risk PCa
genomic classifier (GC)

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases