Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05183074

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Prostate Cancer Adaptive Radiotherapy Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Localised Disease Magnetic Resonance-linac Male Urogenital Diseases Neoplasms Neoplasms by Site Oligometastatic Disease Prostatic Diseases Prostatic Neoplasms Radiation Injuries Radiotherapy Side Effect Stereotactic Ablative RT Urogenital Diseases Urogenital Neoplasms Wounds and Injuries

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location status: Recruiting

Location contact

Nian-Zeng Xing, M.D

PRINCIPAL_INVESTIGATOR

Nian-Zeng Xing, M.D.

CONTACT

[email protected]

Ning-Ning Lu, M.D.

PRINCIPAL_INVESTIGATOR

Ningning Lu, Doctor

CONTACT

[email protected]

+86 01087787630

Ye-Xiong Li, M.D

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MR-Linac

Device

1.5-Tesla MR-linac based SBRT

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

    Time frame: Three months post-MRL-SBRT

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

Secondary outcomes

  1. The Incidence of Late toxicities: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Time frame: 6-months, 1-year and 2-year

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

  2. Quality of life evaluation

    Time frame: 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

  3. Biochemical-relapse free survival

    Time frame: 2-year

Study contacts

Contact information is provided by the study sponsor or research team.

Ning-Ning Lu

CONTACT

[email protected]

+868611804268

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

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

Acronym: SMART-P01/02

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jan 10, 2022
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.