Trial results for a pilot study evaluating a patient-centered intervention for optimizing active surveillance in low-risk Prostate Cancer were posted on ClinicalTrials.gov on 2026-03-06, reporting 39 participants recruited.
Background
Prostate cancer is a common malignancy among men, with a significant proportion diagnosed as low-risk. For these patients, active surveillance (AS) is a recommended management strategy, involving close monitoring rather than immediate aggressive treatment. The goal of AS is to avoid overtreatment and its associated side effects, while still ensuring timely intervention if the disease progresses. However, adherence to active surveillance protocols, which typically involve regular prostate-specific antigen (PSA) tests, digital rectal exams, and repeat biopsies, can be challenging for patients. Maximizing adherence to AS is crucial for its success in managing low-risk prostate cancer and ensuring patient safety. Interventions that support patients and engage primary care physicians (PCPs) in care delivery are being explored to improve AS outcomes.
Trial design
This pilot study, designated as Phase NA, was completed with an enrollment of 39 participants diagnosed with Prostate Cancer. The study evaluated a patient-centered intervention designed to enable providers to support men on active surveillance, aiming to maximize adherence. The trial's brief summary indicated its focus on measuring key patient-reported, provider-reported, and implementation outcomes. No specific primary outcomes were listed in the trial registration, with the study primarily assessing feasibility and acceptability metrics to inform future larger-scale trials. The study did not specify comparator arms, as it was a pilot evaluation of a single intervention.
Key results
The trial results provided several key measurements related to the feasibility and acceptability of the intervention:
- Feasibility - Recruitment: The total study enrollment was 39 Participants.
- Feasibility - Uptake: The total study enrollment for uptake was 30 Participants.
- Acceptability - Mean Satisfaction Scores (Intervention Website): The mean satisfaction score was 3.53 with a Standard Deviation of 0.83 on a scale.
- Acceptability - Mean Satisfaction Scores (Intervention Website): The mean satisfaction score was 3.70 with a Standard Deviation of 0.95 on a scale.
- Acceptability - Mean Satisfaction Scores (Intervention Website): The mean satisfaction score was 3.30 with a Standard Deviation of 1.34 on a scale.
- Acceptability - Mean Satisfaction Scores (Intervention Website): The mean satisfaction score was 2.80 with a Standard Deviation of 1.32 on a scale.
- Acceptability - Mean Satisfaction Scores (Intervention Website): The mean satisfaction score was 3.40 with a Standard Deviation of 1.35 on a scale.
- Acceptability - Mean Satisfaction Scores (Intervention Website): The mean satisfaction score was 4.40 with a Standard Deviation of 0.70 on a scale.
- Acceptability - Mean Satisfaction Scores (Intervention Website): The mean satisfaction score was 3.60 with a Standard Deviation of 1.17 on a scale.
What this means
The posted results from this pilot study suggest that the patient-centered intervention aimed at optimizing active surveillance in low-risk prostate cancer demonstrated initial feasibility and acceptability. The recruitment of 39 participants and an uptake of 30 participants indicate that the study was able to enroll and engage individuals, which is a positive sign for the feasibility of such an intervention. The reported mean satisfaction scores for the intervention website, ranging from 2.80 to 4.40 on a scale, with varying standard deviations, suggest a generally positive reception among participants. These findings are crucial for informing the design of a subsequent multi-center effectiveness-implementation hybrid design trial, as outlined in the study's brief summary. Successfully engaging patients and potentially primary care physicians in care delivery through such interventions could ultimately improve the management of low-risk prostate cancer by enhancing adherence to active surveillance protocols.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05764005, titled "Optimizing Active Surveillance in Low-Risk Prostate Cancer: a Pilot Study", were posted on 2026-03-06 on clinicaltrials.gov.