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

NCT05183074 — Not applicable, Recruiting, 50 participants, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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Phase II Prospective Trial of MR-linac Based Stereotactic Ablative Radiotherapy for Patients With Localized (SAMRT-P01) and Oligo-metastatic (SMART-P02) Prostate Cancer

Registry	NCT05183074, acronym SMART-P01/02
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	50 (Estimated)
Sponsor	Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Other)
Conditions	Prostate Cancer, Radiotherapy Side Effect, Magnetic Resonance-linac, Stereotactic Ablative RT, Adaptive Radiotherapy, Localised Disease, Oligometastatic Disease
Interventions	MR-linac (Device)
Dates	start 2021-02-01, primary completion 2027-12-31 (estimated), completion 2027-12-31 (estimated), first posted 2022-01-10, last updated 2025-12-11
Locations	1 site in China

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
MR-linac group	Experimental	Device: MR-linac	Pts received ultra-hypofractionated RT for primary w/o adjacent oligo-metastatic diseases on 1.5-Tesla MR-Linac

MR-linac (Device): 1.5-Tesla MR-linac based SBRT

+Outcome measures

Primary outcomes

The Incidence of Acute GU and GI toxicities: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Three months post-MRL-SBRT]: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Secondary outcomes

The Incidence of Late toxicities: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [6-months, 1-year and 2-year]: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Quality of life evaluation [Every 2 weeks during SBRT and till 8 weeks after RT completion, every 3 months to 2 years and every 6 months to 5 years, and yearly thereafter]: Evaluate quality of life of patients by QOL questionnaires at different time points
Biochemical-relapse free survival [2-year]

+Eligibility

Sex: Male, ages: 18 Years to any

Inclusion Criteria:

* Age≥18 years。
* Histology confirmed prostate cancer.
* Risk stratification, localised disease including patients with low-risk(cT1-T2a，PSA <10ng/mL，Gleason score≤6) who refuse active surveillance, favorable or unfavorable intermediate-risk and selected high-risk(cT2b-T3a or minimally T3b，PSA 10-40ng/mL，Gleason score 7-8) disease.
* Oligo-metastatic disease including patients with prostate in-situ and oligometastatic disease (no limit to mets number and organs, with all metastatic foci can be safely treated by radical SBRT dose)
* ECOG 0-2
* Postate gland volume ≤100cc
* IPSS score of <18
* Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed

Exclusion Criteria:

* Contraindications to MRI.
* TURP within the past 6 months
* Ulcerative colitis, Crohn's Disease, ataxia telangiectasia, or systemic lupus erythematosus
* Previous pelvic irradiation
* Refuse contraception

+Locations (1)

Facility	City	Country	Status
Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences	Beijing, Beijing Municipality	China	Recruiting