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

ConditionsLocalized Prostate Cancer Stereotactic Body Radiotherapy

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexMale

Age18+

SponsorUniversity Health Network, Toronto

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18 years

Histologic diagnosis of prostate adenocarcinoma

Localized prostate cancer

Low risk, intermediate risk, or high risk allowed

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

320 Participants

are divided into 2 treatment groups

Group A: Non-adaptive image-guided SBRTOther 1 intervention

Group B: Adaptive SBRTOther 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

Within 3 months following radiation therapy

Secondary outcomes

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.

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

Time frame

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.

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

Time frame

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.

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

Time frame

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.

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

Time frame

Within 3 months of radiation therapy

Other outcomes

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.

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

Time frame

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.

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

Time frame

within 2 years following radiation

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov

Apply now