Trial results for a de-implementation study in Prostate Cancer were posted on ClinicalTrials.gov on 2025-06-26, indicating that a 'Provider Script' intervention led to 28 participants interrupting low-value androgen deprivation therapy (ADT) injections.
Background
Prostate cancer management often includes androgen deprivation therapy (ADT), which can be associated with side effects and may sometimes be used in situations where its value is low. Reducing the use of low-value ADT is an important goal to improve patient quality of life and optimize healthcare resources. This trial aimed to explore different strategies to encourage clinicians to de-implement or reduce such low-value ADT use, ensuring that treatment aligns with the most appropriate clinical guidelines and patient needs.
Trial design
This completed study, identified as Phase NA, enrolled 50 participants with Prostate Cancer. The trial compared two strategies designed to reduce low-value ADT use: a clinical reminder order check intervention and a provider script/patient education approach. The primary aim was to assess the impact of these strategies on interruptions in low-value ADT use after six months. The intervention groups were 'ADT Order Check Attestation (Or)' and 'Provider Script (Sc)', with a 'Control' group for comparison.
Key results
The trial evaluated the effectiveness of the interventions by measuring the number of participants who achieved an interruption in low-value ADT injection (i.e., took a break from ADT):
- In the 'ADT Order Check Attestation (Or) - Patients' group, 12 participants achieved an interruption in low-value ADT injection.
- In the 'Provider Script (Sc) - Patients' group, 28 participants achieved an interruption in low-value ADT injection.
- In the 'Control' group, 24 participants achieved an interruption in low-value ADT injection.
Further measurements included:
- The 'Reach' for both 'ADT Order Check Attestation (Or) - Providers' and 'Provider Script (Sc) - Providers' was 100 percentage of provider participants.
- 'Penetration - ADT Order Check Attestation (OR) Intervention' for 'ADT Order Check Attestation (Or) - Providers' was 0 proportion of OR interventions.
- 'Penetration - Provider Script (SC) Intervention' for 'Provider Script (Sc) - Providers' was 64 notes.
- 'Feasibility - Site Level: Medical Center Director (MCD) Approval' was 2 sites for both 'ADT Order Check Attestation (Or) - Providers' and 'Provider Script (Sc) - Providers'.
- 'Feasibility - Site Level: Fully Operationalized Intervention' was 2 sites for both 'ADT Order Check Attestation (Or) - Providers' and 'Provider Script (Sc) - Providers'.
- 'Feasibility - Clinic Level Activation: Clinics With Intervention Implementation' for 'ADT Order Check Attestation (Or) - Providers' was 0 sites.
What this means
The results suggest that the 'Provider Script/Patient Education' strategy was more effective in encouraging interruptions in low-value ADT use among prostate cancer patients, with 28 participants taking a break from ADT compared to 12 in the 'ADT Order Check' group and 24 in the control group. The 'ADT Order Check' intervention showed a penetration of 0 and no clinic-level activation, indicating significant challenges in its implementation or adoption. In contrast, the 'Provider Script' intervention demonstrated a higher number of patient interruptions and a measurable penetration in terms of notes, suggesting it may be a more feasible and impactful approach for de-implementing low-value ADT in clinical practice.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06199986, titled "DeADT - Living Well With Prostate Cancer", were posted on 2025-06-26 on clinicaltrials.gov.