Clinical trial · Interventional
Stereotactic MRI-Guided Radiation for Localized Prostate Cancer
Two Stereotactic MRI-Guided Ablative Adaptive Radiotherapy Treatments for Localized Prostate Cancer (2SMART)
NCT03588819CI-TRIAL-000590842SMARTunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This single arm, prospective study will determine the prostate-specific quality of life (QOL) of patients undergoing undergoing a 2 fraction MRI-guided stereotactic ablative body radiation (SABR) protocol. We propose prescribing a prostate dose of 26 Gy in 2 fractions and a dose of up to 32 Gy to the dominant intraprostatic lesion (DIL) in 2 fractions over one week.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SABR | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 2-fraction SABR
- interventionNames
- Radiation: SABR
Primary outcomes (1)
- measure
- QOL
- timeFrame
- 5 years
- description
- To determine the prostate-specific quality of life (QOL) using the Expanded Prostate Cancer Index Composite (EPIC)
Secondary outcomes (7)
- measure
- Acute Toxicity
- timeFrame
- 3months
- description
- Incidence of acute (≤3 months) complications of interest using Common Terminology Criteria for Adverse Events, version 4.0 (CTCAE v4)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Informed consent obtained 2. Men \>18 years 3. Histologically confirmed prostate adenocarcinoma (centrally reviewed) 4. Favorable risk prostate cancer, defined as clinical stage T1-2c, Gleason Sum less than or equal to 7, and PSA less than or equal to 20 ng/mL (patients can have only one of T2c, Gleason Sum 7 and PSA 10-20 ng/ml) Exclusion Criteria: 1. Androgen deprivation therapy (LHRH-agonists or antiandrogens) \> 6 mo 2. Prior pelvic radiotherapy 3. Anticoagulation medication (if unsafe to discontinue for gold seed insertion) 4. Diagnosis of bleeding diathesis 5. Large prostate (\>90cm3) on imaging 6. Immunosuppressive medications 7. Inflammatory bowel disease 8. Presence of a hip prosthesis 9. Contraindications to having MRI
References
Publications (2)
- DERIVEDOng WL, Davidson M, Cheung P, Chung H, Chu W, Detsky J, Liu S, Morton G, Szumacher E, Tseng CL, Vesprini D, Ravi A, McGuffin M, Zhang L, Mamedov A, Deabreu A, Kulasingham-Poon M, Loblaw A. Dosimetric correlates of toxicities and quality of life following two-fraction stereotactic ablative radiotherapy (SABR) for prostate cancer. Radiother Oncol. 2023 Nov;188:109864. doi: 10.1016/j.radonc.2023.109864. Epub 2023 Aug 22. PMID 37619656
- DERIVEDOng WL, Cheung P, Chung H, Chu W, Detsky J, Liu S, Morton G, Szumacher E, Tseng CL, Vesprini D, Davidson M, Ravi A, McGuffin M, Zhang L, Mamedov A, Deabreu A, Kulasingham-Poon M, Loblaw A. To Boost or Not to Boost: Pooled Analyses From 2-Fraction SABR Trials for Localized Prostate Cancer. Int J Radiat Oncol Biol Phys. 2023 Dec 1;117(5):1153-1162. doi: 10.1016/j.ijrobp.2023.06.250. Epub 2023 Jul 5. PMID 37419394