Actively Recruiting
Phase II Prospective Trial of MR-linac Based Stereotactic Ablative Radiotherapy for Localized and Oligo-metastatic Prostate Cancer
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-12-11
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the tolerability and effects of MR-linac based stereotactic ablative radiotherapy (MRL-SBRT) in patients with localized prostate cancer, including those with oligo-metastatic disease. The study aims to assess acute and late toxicities, treatment efficacy, quality of life, feasibility of dose planning with simultaneous-boosts for MRI-detected tumor areas, and the relationship between blood and tissue biomarkers with imaging changes before and after treatment. Participants receive ultra-hypofractionated radiotherapy using a 1.5-Tesla MR-linac device targeting the prostate without adjacent oligo-metastatic diseases. The treatment is delivered in a specialized manner guided by magnetic resonance imaging to focus on the tumor area. The study includes different risk groups of prostate cancer and allows treatment of all metastatic foci with radical SBRT dose where applicable. During the study, participants are monitored for treatment-related acute and late toxicities using standard criteria up to five years. Quality of life is evaluated regularly from treatment start through several years post-therapy. Researchers also measure biochemical relapse-free survival at two years. Assessments include imaging, biomarker analysis, and patient-reported outcomes. The total participation time includes frequent follow-ups to carefully observe treatment effects and safety.
CONDITIONS
Brief Title
MR-linac Guided Ultra-hypofractionated RT for Prostate Cancer (SMART-P01 and SMART-P02)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histology confirmed prostate cancer
- Localized disease including low-risk (cT1-T2a, PSA <10 ng/mL, Gleason score ≤6) who refuse active surveillance, favorable or unfavorable intermediate-risk, and selected high-risk (cT2b-T3a or minimally T3b, PSA 10-40 ng/mL, Gleason score 7-8) disease
- Oligo-metastatic disease with prostate in situ and metastatic sites treatable by radical SBRT dose
- ECOG performance status 0-2
- Prostate gland volume 100cc or less
- IPSS score less than 18
- Signed informed consent indicating understanding of study risks and investigational nature
You will not qualify if you...
- Contraindications to MRI
- Transurethral resection of the prostate (TURP) within the past 6 months
- Ulcerative colitis, Crohn's Disease, ataxia telangiectasia, or systemic lupus erythematosus
- Previous pelvic irradiation
- Refusal to use contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration consistent with ultra-hypofractionated radiotherapy schedule
Participants receive ultra-hypofractionated radiotherapy using a 1.5-Tesla MR-linac for localized or oligo-metastatic prostate cancer.
Multiple treatment visits as per radiotherapy schedule
Duration - Up to 5 years
Participants are monitored for treatment-related toxicities and quality of life up to 5 years after radiotherapy completion.
Visits every 2 weeks during radiotherapy and until 8 weeks after, then every 3 months to 2 years, every 6 months to 5 years, and yearly thereafter
Trial Site Locations
Total: 1 location
1
Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
N
Ning-Ning Lu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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