Prostate CancerSMART-P01/02NCT05183074
MR-linac Guided Ultra-hypofractionated RT for Prostate Cancer (SMART-P01 and SMART-P02)
A study testing MR-linac in people with Prostate Cancer and Radiotherapy Side Effect, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Radiotherapy Side Effect, Magnetic Resonance-linac
- What is being tested?
- MR-linac
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Ningning Lu, Doctor, +86 01087787630, Ning-Ning.Lu@hotmail.com
Nian-Zeng Xing, M.D., xingnianzeng@126.com
About this study
Official 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
- To investigate the tolerability of MR-linac based stereotactic ablative radiotherapy (MRL-SBRT)for patients with localized prostate cancer
- To assess the acute and late toxicities, efficacy and quality of life for patients treated by MRL-SBRT
- To simulate the dose planning and assess the feasibility of simultaneous-boost for MR-prominent foci
- 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
- Being tested
- MR-linac
- Medical subject headings
- Prostatic Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-linacDevice
1.5-Tesla MR-linac based SBRT
| Study group | Role | What they receive |
|---|---|---|
| MR-linac group | Experimental | Pts received ultra-hypofractionated RT for primary w/o adjacent oligo-metastatic diseases on 1.5-Tesla MR-Linac Receives: Device: MR-linac |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: 6-months, 1-year and 2-year
Quality of life evaluation
Evaluate quality of life of patients by QOL questionnaires at different time points
Measured: 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
Measured: 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start1 Feb 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NINGNING LU, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183074
- Sponsor's protocol ID
- NCC2277
- Acronym
- SMART-P01/02
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2021
- Last updated
- 11 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05183074
- Acronym / sponsor ID
- SMART-P01/02 / NCC2277
- Conditions
- Prostate Cancer, Radiotherapy Side Effect, Magnetic Resonance-linac, Stereotactic Ablative RT, Adaptive Radiotherapy, Localised Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To investigate the tolerability of MR-linac based stereotactic ablative radiotherapy (MRL-SBRT)for patients with localized prostate cancer
- To assess the acute and late toxicities, efficacy and quality of life for patients treated by MRL-SBRT
- To simulate the dose planning and assess the feasibility of simultaneous-boost for MR-prominent foci
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR-linac group | Experimental | Device: MR-linacPts received ultra-hypofractionated RT for primary w/o adjacent oligo-metastatic diseases on 1.5-Tesla MR-Linac |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR-linac1.5-Tesla MR-linac based SBRT | Device | MR-linac group |
Primary outcome
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
3 secondary outcomes
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
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
Biochemical-relapse free survival
Time frame: 2-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR-linac in people with Prostate Cancer and Radiotherapy Side Effect, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ning-Ning Lu (+868611804268, Ning-Ning.Lu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.