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

NCT06825091 | Recruiting Phase 3

• 1 other identifier: 24-5757
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Localized Prostate Cancer; Stereotactic Body Radiotherapy

Outcome Measures

Primary Outcomes (1)

• To determine whether adaptive SBRT can significantly reduce the proportion of patients experiencing a minimal clinically important difference in patient reported urinary domain changes when compared to the non adaptive image guided SBRT group.

  To determine whether adaptive SBRT can significantly reduce the proportion of patients experiencing a minimal clinically important difference (MCID; defined as \>10-point change) in patient reported urinary domain changes by EPIC-26 (The Expanded Prostate Cancer Index Composite) questionnaire. within 3-months following radiation when compared to the non-adaptive image guided SBRT group

  Within 3 months following radiation therapy

Secondary Outcomes (9)

• To determine whether adaptive SBRT to prostate compared to non adaptive image guided SBRT to prostate results in different rates of patient reported outcomes, acute toxicity.

  Within 3 months of radiation therapy

• To determine whether adaptive SBRT to prostate compared to non adaptive image guided SBRT to prostate results in different rates of patient reported outcomes, acute toxicity.

  Within 3 months of radiation therapy

• To determine whether adaptive SBRT to prostate compared to non adaptive image guided SBRT to prostate results in different rates of patient reported outcomes, acute toxicity.

  Within 3 months of radiation therapy

• To determine whether adaptive SBRT to prostate compared to non adaptive image guided SBRT to prostate results in different rates of patient- reported outcomes, acute toxicity.

  Within 3 months of radiation therapy

• To determine whether adaptive SBRT to prostate compared to non adaptive image guided SBRT to prostate results in different rates of patient- reported outcomes at 2 years, late toxicity.

  2 years following radiation.

Other Outcomes (2)

• To determine the impact of magnetic resonance-based adaptive SBRT (e.g., MR-Linac) versus CT-based adapted SBRT (e.g., Ethos) across each of the primary and secondary objectives.

  within 2 years following radiation

• Tertiary endpoints: To determine whether cumulative dosimetric differences between adaptive and non adaptive prostate SBRT correlate with each of the primary and secondary objectives.

  within 2 years following radiation

Study Arms (2)

Non-adaptive image-guided SBRT

OTHER

Patients will receive prostate SBRT. A dose of either 36.25 Gy in 5 fractions (per PACE-B trial) or 42.7 Gy in 7 fractions (per HYPO-RT-PC trial) will be prescribed as per standard practice at PMH. Patients will receive SBRT every other day, excluding weekends and holidays, as per standard practice. Patients will undergo radiotherapy simulation as per standard practice with CT and MR simulation (or without MR if contraindication).

Radiation: SBRT

Adaptive SBRT

OTHER

Patients will receive prostate SBRT. A dose of either 36.25 Gy in 5 fractions (per PACE-B trial) or 42.7 Gy in 7 fractions (per HYPO-RT-PC trial) will be prescribed as per standard practice. Patients will receive SBRT every other day, excluding weekends and holidays, as per standard practice. Patients will undergo radiotherapy simulation as per standard practice with CT and MR simulation (or without MR if contraindication).

Radiation: SBRT

Interventions

SBRT RADIATION

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.

Adaptive SBRT; Non-adaptive image-guided SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Central Study Contacts

Rachel Glicksman, MD

CONTACT

416-946-4559; rachel.glicksman@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2025
• First Posted: February 13, 2025
• Study Start: February 4, 2025
• Primary Completion (Estimated): February 4, 2030
• Study Completion (Estimated): February 4, 2030
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

CA (1)