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
About This Trial
- This clinical trial is studying a precise form of high-dose radiation therapy that uses real-time MRI scans to clearly see and target tumors while protecting nearby healthy tissue.
- Researchers want to learn how safe and effective this treatment is and how it affects patients' overall quality of life.
- The study is open to adults with prostate cancer that is either confined to the prostate or has only spread to a small number of other areas.
- Before considering this trial, patients should know that they must be able to safely have MRI scans and cannot have had prior pelvic radiation or recent prostate surgery.
More Information
- 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
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This clinical trial is studying a precise form of high-dose radiation therapy that uses real-time MRI scans to clearly see and target tumors while protecting nearby healthy tissue.
Study Details
- Start Date: February 1, 2021
- Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Full 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
Treatments
- Device: MR-linac