MR-linac Guided Ultra-hypofractionated RT for Prostate Cancer (SMART-P01 and SMART-P02)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MR-linac.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Radiotherapy Side Effect, Magnetic Resonance-linac, Stereotactic Ablative RT. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
Interventions
- Device MR-linac
1.5-Tesla MR-linac based SBRT
Primary outcome measures
- 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]
Secondary outcome measures (3)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences — Beijing
Identifiers
NCT: NCT05183074 · NCC2277