Clinical trial · Observational
Long-term Study to Evaluate and Clinical Outcomes in Patients With Favorable Intermediate Risk Localized Prostate Cancer
Long-Term Prospective Registry to Evaluate Treatment Decisions and Clinical Outcomes in Patients With Favorable Intermediate-Risk Localized Prostate Cancer Following Cell Cycle Progression (CCP) Testing (Prolaris® Test)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): There is sufficient follow-up data to meet the endpoints of the study.
Summary
Brief summary (as posted)
This is a long-term prospective registry study to determine whether Prolaris testing in patients with favorable intermediate risk prostate cancer influences physician management decisions toward conservative treatment in patients with Prolaris low-risk scores without negatively impacting patient oncologic outcomes, thereby sparing low-risk patients from unnecessary treatments and associated side-effects.
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 Testing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Prolaris Testing
- description
- Recently diagnosed treatment-naïve patients with early stage localized prostate cancer who undergo Prolaris testing
- interventionNames
- Diagnostic Test: Prolaris Testing
- label
- No Prolaris Testing
- description
- Patients with newly diagnosed favorable intermediate-risk localized prostate cancer who DO NOT undergo Prolaris testing
Primary outcomes (3)
- measure
- Low Prolaris Score, on Active Surveillance
- timeFrame
- 3 years
- description
- Proportion of patients with low Prolaris scores who are initially treated with active surveillance
- measure
- Low Prolaris Score, Definitive Treatment Following Active Surveillance
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria:
* Patients who have undergone CCP testing and patients who have not undergone CCP testing will be considered for enrollment in the study.
1. Willing to provide written informed consent.
2. Males ≥65 years old.
3. Newly diagnosed (≤6 months), treatment-naïve patient with histologically proven localized adenocarcinoma of prostate whose initial treatment has not been decided.
4. Candidate for and considering AS and yet would be eligible for definitive therapy.
5. Favorable intermediate-risk disease, defined by the NCCN as follows:
* predominant Gleason grade 3; AND
* percentage of positive cores \<50%; AND
* no more than 1 of the following NCCN intermediate-risk factors:
* Gleason grade 7
* T2b-T2c
* PSA 10-20 ng/mL
6. Estimated life expectancy ≥10 years.
7. Can be monitored for disease progression according to standard of care (e.g., current NCCN guidelines).
Exclusion Criteria:
* 1\. Clinical evidence of metastasis or lymph node involvement.
* 2\. Received pelvic radiation prior to biopsy.
* 3\. Received androgen deprivation therapy (ADT) prior to biopsy; however, 5 alpha-reductase inhibitors (5-ARIs) are permitted.
* 4\. Participation in interventional clinical trials.
* 5\. Patient is considering watchful waiting.
* 6\. Has a known history of hypogonadism.References
Publications (0)
Data not yet available