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)


Condition: Prostate Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT02723734

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Phase:

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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

View trial on ClinicalTrials.gov


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