Last reviewed · How we verify
NCT06825091: ASPIRE
Is Adaptive SBRT for Prostate vs Image-guided Radiotherapy a True Evolution (ASPIRE)
Phase 3 trial testing SBRT in Localized Prostate Cancer in 320 participants. Currently enrolling.
4 February 2030
Quick facts
| Lead sponsor | University Health Network, Toronto |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 320 |
| Start date | 4 February 2025 |
| Primary completion | 4 February 2030 |
| Estimated completion | 4 February 2030 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- SBRT — full drug profile →
Conditions studied
- Localized Prostate Cancer — all drugs for Localized Prostate Cancer →
- Stereotactic Body Radiotherapy — all drugs for Stereotactic Body Radiotherapy →
Sponsor
University Health Network, Toronto
Who can join
18 and older, male only, with Localized Prostate Cancer or Stereotactic Body Radiotherapy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06825091
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of SBRT
Trials testing the same drug.
- NCT07535632 — SBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal Cance · Phase 2 · not yet recruiting
- NCT07537777 — Benmelstobart Plus Anlotinib Combined With SBRT for Patients With Hepatocellular Carcinoma Failing First-Line Targeted T · Phase 2 · not yet recruiting
- NCT07504939 — Multimodal Kidney-Sparing Strategy for High-Risk Upper Tract Urothelial Carcinoma · not yet recruiting
- NCT07451795 — SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC · Phase 2 · recruiting
- NCT07410234 — Phase II Exploratory Study of Toripalimab Combined With SBRT in HER2-Negative Breast Cancer Patients With Insensitivity · Phase 2 · not yet recruiting
Other recruiting trials for Localized Prostate Cancer
Currently open trials in the same condition.
- NCT06966778 — Oxybutynin ER to Promote Early Continence Recovery After Robotic Prostatectomy: A Randomized Controlled Trial · NA · recruiting
- NCT06117059 — The PRECISION Study: 3 Fractions of Prostate SBRT and RayPilot HypoCath Image Guidance · NA · recruiting
- NCT06325774 — Radical Hypofractionated Radiotherapy for Localized Prostate Cancer · NA · recruiting
- NCT06362577 — Clinical Study of HIFU for Localized Prostate Cancer · recruiting
- NCT06325995 — Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer · NA · recruiting
Other University Health Network, Toronto trials
Trials by the same sponsor.
- NCT06831032 — Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response · NA · recruiting
- NCT06634056 — Pneumonitis Prevention Protocol Using Pentoxifylline and α-tocopherol In Stage III Non-Small Cell Lung Cancer Patients U · Phase 2 · not yet recruiting
- NCT06836726 — Clinical Trial to Test Efficacy of Targeting Hypoxia Combined With ARSI After First-line ARSI Therapy for Castrate Resis · Phase 2 · not yet recruiting
- NCT07515651 — Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas · Phase 2 · not yet recruiting
- NCT07509450 — Fecal Microbiota Transplantation in Patients Undergoing Chimeric Antigen Receptor T-cell Therapy and Allogeneic Stem Cel · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06825091 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Health Network, Toronto
- Last refreshed: 28 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06825091.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing