Clinical trial · Observational
Prospective Prolaris Value and Efficacy
Two-Part Prospective Study to Measure Impact of Prolaris® Testing Added to Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients to Measure Prediction of Progression/Recurrence in Men Treated at VAMC
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Myriad has sufficient data to do an analysis on the primary objective, durability, and has made the decision not to continue collecting data for the other study objectives.
Summary
Brief summary (as posted)
This is a prospective study to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prolaris | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Early Stage Prostate Cancer
- description
- Recently diagnosed treatment-naïve patients with early stage localized prostate cancer
- interventionNames
- Behavioral: Prolaris
Primary outcomes (2)
- measure
- Impact of Prolaris on the magnitude of change between Pre-Prolaris treatment selection and the actual implemented treatment
- timeFrame
- 6 months
- description
- Comparison of percentage change from the Pre-Prolaris test treatment option (based on standard clinical pathological parameters) versus the actual treatment option implemented following results of Prolaris
- measure
- Prolaris prediction of biochemical or objective recurrence
- timeFrame
- 5 years
- description
- Biochemical recurrence (defined as PSA \>0.2 ng/ml or by Phoenix definition) or objective recurrences of disease by 5 years following definitive therapy with curative intent in men treatment with radical prostatectomy or radiation therapy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed (\<= 6 months), untreated patients with histologically proven adenocarcinoma of the prostate * Final treatment decision has not been made (that is all treatment options are feasible and none have been ruled out due to comorbidities at study entry) * Clinically localized (no evidence on clinical or imaging studies of advanced disease) * No hormonal therapy for treatment of prostate cancer including LHRH agonist or antagonist, anti-androgen, estrogens or exogenous androgens when applicable (use of 5-alpha reductase inhibitors is acceptable) * Sufficient amount of tissue remains from biopsy to perform genomic testing * Life expectance of a minimum of 10 years * Men who completed PART 1 and were treated with radical prostatectomy (including robotic, laparoscopic, open retropubic or perineal) or receive radiation therapy or were placed on AS or WW. Exclusion Criteria: * Men with clinical node positive or metastatic disease * Men with a known baseline total serum testosterone level of \<100 ng/dL prior to radiation or hormone therapy (men with unknown baseline testosterone levels will not be excluded) * Men who previously received pelvic radiotherapy for another malignancy * Non adenocarcinoma prostate cancer histologies
References
Publications (0)
Data not yet available