RecruitingPhase 3NCT06825091

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


Sponsor

University Health Network, Toronto

Enrollment

320 participants

Start Date

Feb 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: MALEMin Age: 18 Years

Inclusion Criteria5

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

Exclusion Criteria2

  • Planned for elective nodal irradiation
  • Contraindications to radiotherapy

Interventions

RADIATIONSBRT

Standard of care SBRT (36.25 Gy in 5 fractions or 42.7 Gy in 7 fractions) for localized prostate cancer, delivered either via an adaptive or a non-adaptive image-guided treatment. Androgen deprivation therapy use and duration is at the discretion of the treating physician and patient, in accordance with standard practice based on patients' prostate cancer risk group.


Locations(1)

Princess Margaret Cancer Center

Toronto, Ontario, Canada

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NCT06825091


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