Clinical trial · Observational
Comprehensive Monitoring of Men With Prostate Cancer Cared for by "Active Surveillance
- 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)
Prostate cancer is the most commonly diagnosed cancer in men. However, there is a wide range in prognosis determined by a host of factors. This study will evaluate the feasibility of guiding therapeutic intervention electronically facilitated symptom and disease monitoring in patients being followed on Active Surveillance. Additionally, we will develop a tissue and data resource to support discovery and hypothesis generation to evaluate germline and/or somatic alterations in relation to cancer-specific and overall outcomes..
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 |
|---|---|---|---|
| Active Surveillance | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Cohort-1
- description
- Participants with localized very low- or low-risk prostate cancer meeting consensus criteria for active surveillance
- interventionNames
- Other: Active Surveillance
- label
- Cohort-2
- description
- Participants with NCCN intermediate-risk localized prostate cancer requesting active surveillance (per patient and clinician shared decision making);
- interventionNames
- Other: Active Surveillance
- label
- Cohort-3
- description
- Participants with severe medical comorbidities (defined as CCI estimated 10-year survival \< 50% and agreed by treating clinician) and high- or very high-risk group localized prostate cancer. Clinical trial investigators and staff will make every effort to integrate study visits with the subjects' clinic visits during participation.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: 1. Patients will have histologic diagnosis of adenocarcinoma of the prostate within 24 months of study entry. 2. Patient must meet at least one of the following clinical indications for AS: National Comprehensive Cancer Network (NCCN) very low risk or low risk prostate cancer meeting consensus guidelines for AS; NCCN intermediate-risk prostate cancer requesting AS (per patient and clinician shared decision making); or have severe medical comorbidities (defined as CCI estimated 10-year survival \< 50% and agreed by treating clinician) with high- or very high-risk localized prostate cancer. 3. Patients must agree to comply with the surveillance schedule. 4. Patients must be over 18 years of age 5. Written informed consent 6. Patients must be fluent in the English language to participate in the patient report outcome and symptoms monitoring portion of the trial. Exclusion criteria: 1. Patients are ineligible if they choose not to share their medical data for research purposes. 2. Prior radiation therapy for treatment of the primary tumor. 3. Planned concomitant hormonal therapy, chemotherapy, or radiation therapy while on protocol
References
Publications (0)
Data not yet available