NCT05183074Recruiting
MR-linac Guided Ultra-hypofractionated RT for Prostate Cancer (SMART-P01 and SMART-P02)
Phase II Prospective Trial of MR-linac Based Stereotactic Ablative Radiotherapy for Patients With Localized (SAMRT-P01) and Oligo-metastatic (SMART-P02) Prostate Cancer
Source: ClinicalTrials.gov · Last updated 11 Dec 2025
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 2 Dec 2021
- Start date
- 1 Feb 2021
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Prostate cancer
- NCT number
- NCT05183074
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 1 Feb 2021 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous pelvic irradiation
Other illness
- Ulcerative colitis, Crohn's Disease, ataxia telangiectasia, or systemic lupus erythematosus
Other
- Contraindications to MRI.
- TURP within the past 6 months
- Refuse contraception
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.