Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT03203460
Brief Summary:
The broad goal of the Exercise During Active Surveillance for Prostate Cancer (ERASE) trial is to examine the effects of exercise in prostate cancer patients undergoing active surveillance.
Detailed Description:
The ERASE Trial will be a phase II randomized controlled trial. A total of 66 men with low- or intermediate-grade clinically localized prostate cancer undergoing active surveillance will be randomized to either a 12-week of supervised high-intensity aerobic interval training or usual care. The primary outcome will be peak oxygen consumption (VO2peak) as a measure of physical fitness. The secondary outcomes include tumour-related biomarkers, fear of cancer progression, quality of life, and psychological distress. Exploratory outcomes will include indicators of cancer progression including prostate-specific antigen. Based on this sample size, our study has 80% power with a two-tailed alpha \<0.05 to detect a clinically meaningful effect of 3.5 ml/kg/min on our primary outcome of VO2max. This power will also be sufficient for detecting differences in our secondary biomarkers and patient-reported outcomes if the effects are at least moderate (i.e., a standardized effect size of d=0.60).
Study:
NCT03203460
Study Brief:
Protocol Section:
NCT03203460