RecruitingRecruiting
Is Adaptive SBRT for Prostate vs Image-guided Radiotherapy a True Evolution (ASPIRE)
NCT06825091 · University Health Network, Toronto
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
The ASPIRE study is a Phase III randomized, single-center study designed to evaluate whether adaptive stereotactic body radiotherapy (SBRT) offers superior clinical benefits compared to standard image-guided SBRT for patients with localized prostate cancer. It aims to explore whether adaptive SBRT can improve urinary outcomes while maintaining effective cancer control.
This interventional study is randomized, single-institution, and includes 320 participants with localized prostate cancer. Patients will be stratified based on fractionation schedules (5 vs. 7 fractions), use of rectal spacers, androgen deprivation therapy (ADT), and baseline alpha receptor antagonist use. Participants will be randomized to receive either adaptive SBRT or standard image-guided SBRT, with both arms adhering to established dosing protocols.
Inclusion criteria includes an age greater than 18 years, diagnosed with localized prostate adenocarcinoma, and an ECOG performance status of 0-1, Eligible for prostate SBRT. The exclusion criteria includes patients who plan for elective nodal irradiation and contraindications to radiotherapy or MRI (for MR-Linac patients).
Eligibility criteria
Inclusion Criteria:
1. Age \>18 years
2. Histologic diagnosis of prostate adenocarcinoma
3. Localized prostate cancer
4. Low risk, intermediate risk, or high risk allowed
5. Patient planned for prostate SBRT
Exclusion Criteria:
1. Planned for elective nodal irradiation
2. Contraindications to radiotherapy
3. Patients with bilateral hip replacements, as they are ineligible for adaptive treatments at present time (either MR-guided or CT-guided)
Study design
Enrollment target: 320 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-02-04
Estimated completion: 2030-02-04
Last updated: 2026-06-02
Interventions
Radiation: SBRT
Primary outcomes
- • To determine whether adaptive SBRT can significantly reduce the proportion of patients experiencing a minimal clinically important difference in patient reported urinary domain changes when compared to the non adaptive image guided SBRT group. (Within 3 months following radiation therapy)
Sponsor
University Health Network, Toronto · other
Contacts & investigators
ContactRachel Glicksman, MD · contact · rachel.glicksman@uhn.ca · 416-946-4559
All locations (1)
Princess Margaret Cancer CenterRecruiting
Toronto, Ontario, Canada