The Phase 3 'Prostate Advances in Comparative Evidence' (PACE) trial, investigating various treatment strategies for Prostate Cancer, reached its primary completion date on 2025-12-31. This international multicenter study enrolled 2205 participants.
Background
Prostate cancer is a common malignancy affecting men, with treatment decisions often guided by disease risk stratification (low, intermediate, high). Current management options include active surveillance, surgery (prostatectomy), and various forms of radiation therapy, including conventionally fractionated radiotherapy and stereotactic body radiation therapy (SBRT). The choice of treatment can depend on factors such as disease stage, patient age, comorbidities, and personal preferences. Comparative studies like PACE are crucial for evaluating the efficacy and safety of these different approaches to optimize patient outcomes.
Trial design
This Phase 3 international multicenter randomized study, titled 'Prostate Advances in Comparative Evidence' (PACE), enrolled 2205 participants with Prostate Cancer across low, intermediate, and high-risk groups. The trial design incorporates three parallel randomization schemes:
- Low and intermediate-risk patients for whom surgery is a consideration were randomized to either prostatectomy or prostate SBRT.
- Low and intermediate-risk patients for whom surgery is not a consideration were randomized to either conventionally fractionated radiotherapy or prostate SBRT.
- Intermediate and high-risk patients for whom ADT treatment was considered...
The study aims to compare these different treatment modalities.
Source
The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The details for study NCT01584258 were updated on 2025-12-31 on clinicaltrials.gov.