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

Study acronym: ASPIRE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 19 wordsv4 See this version in full on ClinicalTrials.gov ↗
  2. Primary and study completion dates: Apr 1, 2030 to Feb 4, 2030 Start date changed from estimate of Apr 1, 2025 to Feb 4, 2025v3 Show 1 more changeShow less
    • Start date changed from estimate of Apr 1, 2025 to Feb 4, 2025
  3. Trial status: Not Yet Recruiting to Recruiting Eligibility criteria shortened, about 33 words · Site details revisedv2 Show 2 more changesShow less
    • Eligibility criteria shortened, about 33 words
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06825091
Lead Sponsor University Health Network, Toronto
Conditions Localized Prostate Cancer, Stereotactic Body Radiotherapy
Enrollment 320 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov