Clinical trial · Observational
Early Prostate Cancer: Predicting Treatment Response
Precision Medicine for Early Prostate Cancer: Integrating Biological and Patient Complexity Variables to Predict Treatment Response
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will replicate/validate the risk prediction model developed for the Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study in a more diverse patient population to assess generalizability of the model as well as evaluate the relative contribution of the Decipher Prostate Cancer Test and ProstateNext Test from Ambry Genetics, to the risk prediction model for estimating treatment outcomes, and thereby improve personalization of treatment options.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Prostate-Cancer-specific change in quality of life
- timeFrame
- Day of enrollment, 6-months, and 12-months after enrollment
- description
- Quality of life is measured by the Expanded Prostate Cancer Index Composite (EPIC). The Expanded Prostate Cancer Index Composite \[EPIC\] is a validated instrument for measuring disease-specific function/ The domain scores range from 0 to 100, with higher scores representing better function. Patients will be asked to complete the questionnaires during a consultation visit or remotely. EPIC scores will be collected at baseline, 6 month follow up, and at 12 month follow up via the questionnaire. EPIC scores from each time point will then be compared to look at the change in quality of life over the duration of the study.
Secondary outcomes (2)
- measure
- Recurrence of cancer
- timeFrame
- EMR data abstraction around the 6-month time point after enrollment
- description
- Recurrence will be recorded from data abstraction from the electronic medical records (EMR).
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * 18 - 90 years of age * Prostate-Specific Antigen (PSA) values \<50ng/ml * Clinical stage of T1 or T2 * No evidence of metastasis or nodal involvement Exclusion Criteria: * Age 91 or greater * Clinically locally advanced or metastatic disease * PSA equal to or greater than 50ng/ml * Diagnosis of malignancy (excluding squamous or basal cell carcinoma of the skin) within 3 years of diagnosis of prostate cancer
References
Publications (0)
Data not yet available