Clinical trial · Observational
Registry to Measure the Impact of Adding Genomic Testing
An Open Registry to Measure the Impact of Adding Genomic Testing (Prolaris®) on the Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients at Intermountain Hospitals
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of enrollment
Summary
Brief summary (as posted)
This is a prospective open registry 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. Physicians will complete a series of questionnaires. Biopsy tissue will be tested using the Prolaris® genomic test and a relative cancer aggressiveness score will be shared with the physician and the patient.
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 |
|---|---|---|---|
| Registry | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The impact of genomic test results towards selecting a first-line therapy option for newly diagnosed, localized, prostate cancer patients.
- timeFrame
- Three months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed (\< or equal to 12 months), untreated patients with histologically proven adenocarcinoma of the prostate that have the following characteristics: * PSA less than or equal to 10 ng/dl and * Gleason's 7 (4+3 or 3+4) or Gleason's 6 and * Age greater than 55 years old and * Clinical Stage T1 or T2 * Clinically localized (no evidence on clinical or imaging studies of advanced disease). * No hormonal therapy including luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, anti-androgen, estrogens or exogenous androgens, when applicable. Exclusion Criteria: \- Known history of hypogonadism
References
Publications (0)
Data not yet available