Actively Recruiting
MR-linac Guided Ultra-hypofractionated RT for Prostate Cancer (SMART-P01 and SMART-P02)
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-12-11
50
Participants Needed
1
Research Sites
360 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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
- Oligometastatic disease with prostate in-situ and all metastatic sites safely treatable by radical SBRT dose
- ECOG performance status 0-2
- Prostate gland volume ≤100 cc
- IPSS score less than 18
- Signed informed consent indicating understanding of investigational nature and risks
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
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
CONTACT
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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