Clinical Trial 18523

Cancer Type: Genitourinary
Interventions:Not Applicable

Study Type: Other
Phase of Study: NA
Investigators:

  • Kosj Yamoah

Overview

Study 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)

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.

Objective

Primary Objective: To estimate the performance of the GC in physician treatment decision-making in AAM and NAAM with low-intermediate risk PCa. Secondary Objective: 1. To compare the AUC for GC for predicting adverse pT3 disease AAM vs. NAAM with PCa. 2. To measure the agreement between biopsy-based GC vs. prostatectomy-based GC.

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 and less than 20 ng/ml, or T-stage less than or equal to 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 androgen deprivation therapy (ADT) alone after diagnostic biopsy
  • On active surveillance for > 6 months after diagnosis