Actively Recruiting

Phase 3
Age: 18Years +
MALE
NCT06825091

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

Led by University Health Network, Toronto · Updated on 2026-01-28

320

Participants Needed

1

Research Sites

260 weeks

Total Duration

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AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years
  • Histologic diagnosis of prostate adenocarcinoma
  • Localized prostate cancer
  • Low risk, intermediate risk, or high risk prostate cancer allowed
  • Planned to receive prostate SBRT
Not Eligible

You will not qualify if you...

  • Planned for elective nodal irradiation
  • Contraindications to radiotherapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
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Trial Site Locations

Total: 1 location

1

Princess Margaret Cancer Center

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

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Research Team

R

Rachel Glicksman, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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