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

NCT05183074 | Recruiting

• 1 other identifier: NCC2277
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To investigate the tolerability of MR-linac based stereotactic ablative radiotherapy (MRL-SBRT)for patients with localized prostate cancer
2. 2.To assess the acute and late toxicities, efficacy and quality of life for patients treated by MRL-SBRT
3. 3.To simulate the dose planning and assess the feasibility of simultaneous-boost for MR-prominent foci
4. 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

Conditions

Prostate Cancer; Radiotherapy Side Effect; Magnetic Resonance-linac; Stereotactic Ablative RT; Adaptive Radiotherapy; Localised Disease; Oligometastatic Disease

Outcome Measures

Primary Outcomes (1)

• The Incidence of Acute GU and GI toxicities: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  Three months post-MRL-SBRT

Secondary Outcomes (3)

• 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

• 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

• Biochemical-relapse free survival

  2-year

Study Arms (1)

MR-linac group

EXPERIMENTAL

Pts received ultra-hypofractionated RT for primary w/o adjacent oligo-metastatic diseases on 1.5-Tesla MR-Linac

Device: MR-linac

Interventions

MR-linac DEVICE

1.5-Tesla MR-linac based SBRT

MR-linac group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Wounds and Injuries

Central Study Contacts

Ning-Ning Lu

CONTACT

+868611804268; Ning-Ning.Lu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: January 10, 2022
• Study Start: February 1, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

CN (1)