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NCT Number: NCT06825091

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

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).

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Key information

Conditions

Localized Prostate Cancer Stereotactic Body Radiotherapy

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

Location status: Recruiting

Location contact

Rachel Glicksman, MD

CONTACT

[email protected]

416-946-4559 ext. 4961

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • Planned for elective nodal irradiation
  • Contraindications to radiotherapy
  • Patients with bilateral hip replacements, as they are ineligible for adaptive treatments at present time (either MR-guided or CT-guided)

Treatment and study plan

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.

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.

    Time frame: Within 3 months following radiation therapy

    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

Secondary outcomes

  1. 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.

    Time frame: Within 3 months of radiation therapy

    Patient reported bowel via EPIC-26 (The Expanded Prostate Cancer Index Composite) questionnaire.

  2. 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.

    Time frame: Within 3 months of radiation therapy

    Patient reported sexual outcomes via EPIC -26 (The Expanded Prostate Cancer Index Composite) questionnaire.

  3. 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.

    Time frame: Within 3 months of radiation therapy

    Patient reported urinary outcomes via EPIC-26 (The Expanded Prostate Cancer Index Composite) questionnaire.

  4. 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.

    Time frame: Within 3 months of radiation therapy

    Patient reported urinary outcomes via I-PSS (International Prostate Symptom Score).

  5. 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.

    Time frame: 2 years following radiation.

    Patient reported bowel, sexual, and urinary outcomes via EPIC-26 (The Expanded Prostate Cancer Index Composite) at 2 years.

  6. 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.

    Time frame: 2 years following radiation

    Patient reported urinary outcomes via I-PSS (International Prostate Symptom Score) questionnaire at 2 years.

  7. To determine whether adaptive SBRT to prostate compared to non adaptive image guided SBRT to prostate results in different cumulative incidence of biochemical failure and distant metastases.

    Time frame: Within 3 months of radiation therapy

    Determine the acute toxicity at 3 months via CTCAE v5.0 (Common Terminology Criteria for Adverse Events).

  8. To determine whether adaptive SBRT to prostate compared to non adaptive image guided SBRT to prostate results in different cumulative incidence of biochemical failure and distant metastases.

    Time frame: 2 years following radiation

    To determine the late toxicity at 2 years via the CTCAE v5.0 (Common Terminology Criteria for Adverse Events).

  9. To determine the economic impact of adaptive SBRT to prostate compared to non adaptive image guided SBRT to prostate.

    Time frame: 2 years following radiation

    The cumulative incidence of biochemical failure and distant metastases, economic impact.

Other outcomes

  1. 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.

    Time frame: within 2 years following radiation

    MR-based vs CT-based adaptive SBRT across each of the primary and secondary endpoints.

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

    Time frame: within 2 years following radiation

    Adaptive vs non-adaptive target and organ-at-risk dosimetric differences.

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Glicksman, MD

CONTACT

[email protected]

416-946-4559 ext. 4961

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Acronym: ASPIRE

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Feb 13, 2025
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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