Is Adaptive SBRT for Prostate vs Image-guided Radiotherapy a True Evolution (ASPIRE)

Recruiting now · Phase 3

Conditions studied: Localized Prostate Cancer, Stereotactic Body Radiotherapy

In brief

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).

Key facts

Study ID

NCT06825091

Run by

University Health Network, Toronto

People needed

320

Starts

2025-02-04

Expected to finish

2030-02-04

Last updated by the study team

2026-06-02

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Age >18 years
• Histologic diagnosis of prostate adenocarcinoma
• Localized prostate cancer
• Low risk, intermediate risk, or high risk allowed
• Patient planned for prostate SBRT

You may not qualify if…

• Planned for elective nodal irradiation
• Contraindications to radiotherapy
• Patients with bilateral hip replacements, as they are ineligible for adaptive treatments at present time (either MR-guided or CT-guided)

Where it is running

• Princess Margaret Cancer Center — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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