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