Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 and up Men only

Comparing adaptive SBRT to standard image-guided SBRT for localized prostate cancer

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

Run by University Health Network, Toronto · NCT06825091 · Data updated 2026-11-12

This study is testing if a new type of targeted radiation therapy for prostate cancer can improve urinary health compared to the standard radiation treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment320 (estimated)
SponsorUniversity Health Network, Toronto
Academic / other
Locations1 site (Toronto, Ontario)
StatusRecruiting
StartedFebruary 4, 2025
Main results expectedFebruary 4, 2030
Study endsFebruary 4, 2030
Registry record updatedJune 2, 2026
Trial IDNCT06825091 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include men over 18 years old diagnosed with localized prostate adenocarcinoma who are eligible for SBRT.

Probably not a fit

Patients who are planned for elective nodal irradiation or have contraindications to radiotherapy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The ASPIRE study is a Phase III randomized trial that investigates the effectiveness of adaptive stereotactic body radiotherapy (SBRT) compared to standard image-guided SBRT in patients with localized prostate cancer. This single-center study will enroll 320 participants and aims to determine if adaptive SBRT can enhance urinary outcomes while ensuring effective cancer control. Patients will be randomized into two groups, receiving either adaptive SBRT or standard SBRT, with stratification based on various clinical factors. The study will adhere to established dosing protocols for both treatment arms.

Why it matters

Potential benefit: If successful, this study could lead to improved urinary outcomes for patients undergoing treatment for localized prostate cancer.

How similar studies have gone: Other studies have shown promising results with adaptive radiotherapy approaches, suggesting potential benefits in similar contexts.

Who can join: the full rules

Show full inclusion / exclusion 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)

Where it's running

  • Princess Margaret Cancer Center
    Toronto, Ontario, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.