NCT05183074: SMART-P01/02

MR-linac Guided Ultra-hypofractionated RT for Prostate Cancer (SMART-P01 and SMART-P02)

Recruiting now NA Last updated 11 December 2025

What this trial tests

NA trial testing MR-linac in Prostate Cancer in 50 participants. Currently enrolling.

Timeline

1 February 2021

Primary endpoint
31 December 2027

31 December 2027

Quick facts

Lead sponsor	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 February 2021
Primary completion	31 December 2027
Estimated completion	31 December 2027
Sites	1 location across China

Drugs / interventions tested

• MR-linac

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →
• Radiotherapy Side Effect — all drugs for Radiotherapy Side Effect →
• Magnetic Resonance-linac — all drugs for Magnetic Resonance-linac →
• Stereotactic Ablative RT — all drugs for Stereotactic Ablative RT →

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Who can join

18 and older, male only, with Prostate Cancer or Radiotherapy Side Effect. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

1. To investigate the tolerability of MR-linac based stereotactic ablative radiotherapy (MRL-SBRT)for patients with localized prostate cancer
2. To assess the acute and late toxicities, efficacy and quality of life for patients treated by MRL-SBRT
3. To simulate the dose planning and assess the feasibility of simultaneous-boost for MR-prominent foci
4. To investigate the relationship between the changes of blood and tissue biomarkers and manifestations on mp-MRI pre-/post-MRL-SBRT, to further ascertain the predictive factors of local persisting and/or relapse disease

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Stereotactic Magnetic Resonance-Guided Adaptive and Non-Adaptive Radiotherapy on Combination MR-Linear Accelerators: Current Practice and Future Directions.
   Bryant JM, Weygand J, Keit E, Cruz-Chamorro R, et al · · 2023 · cited 24× · PMID 37046741 · DOI 10.3390/cancers15072081
2. MR-LINAC, a New Partner in Radiation Oncology: Current Landscape.
   Ocanto A, Torres L, Montijano M, Rincón D, et al · · 2024 · cited 18× · PMID 38254760 · DOI 10.3390/cancers16020270
3. Assessment of delivered dose in prostate cancer patients treated with ultra-hypofractionated radiotherapy on 1.5-Tesla MR-Linac.
   Gao LR, Tian Y, Wang MS, Xia WL, et al · · 2023 · cited 6× · PMID 36741014 · DOI 10.3389/fonc.2023.1039901
4. Adaptive ultra-hypofractionated whole-pelvic radiotherapy in high-risk and very high-risk prostate cancer on 1.5-Tesla MR-Linac: Estimated delivered dose and early toxicity results.
   Gao L, Wei R, Qin S, Tian Y, et al · · 2024 · cited 2× · PMID 38450305 · DOI 10.1002/cdt3.114
5. A Personalized Approach for Oligometastatic Prostate Cancer: Current Understanding and Future Directions.
   Alerasool P, Zhou S, Miller E, Anker J, et al · · 2025 · cited 1× · PMID 39796774 · DOI 10.3390/cancers17010147
6. Magnetic resonance-guided simultaneous multi-fo​cal adaptive radiotherapy for prostate, pElvis & metastases (MRgSMART-PEM) in prostate cancer: a prospective phase II study.
   Sun M, Qin SR, Wei R, Tian Y, et al · · 2026 · PMID 41689033 · DOI 10.1186/s13014-026-02799-9
7. Safety of online MR-based adaptive ultra-hypofractionated radiotherapy for prostate cancer in China: Preliminary analysis of data from a phase II trial
   Lu N, Han S, Tian Y, Qin S, et al · · 2022 · DOI 10.21203/rs.3.rs-1611219/v2