RecruitingNot ApplicableNCT05183074

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


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

50 participants

Start Date

Feb 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a precise radiation technique called ultra-hypofractionated stereotactic body radiation therapy (SBRT), guided by an MRI-equipped radiation machine (MR-Linac), to treat localized or oligometastatic prostate cancer in fewer, higher-dose sessions than conventional radiation. **You may be eligible if:** - You are 18 years or older - You have been diagnosed with prostate cancer confirmed by biopsy - Your cancer is low, intermediate, or selected high-risk localized prostate cancer, or has spread to a limited number of sites that can all be safely treated with radiation - Your prostate gland is not too large (under 100cc) and your urinary symptoms are mild (IPSS score below 18) - You are in reasonably good health (ECOG 0–2) **You may NOT be eligible if:** - You have a contraindication to MRI - You had a TURP (prostate scraping procedure) within the past 6 months - You have inflammatory bowel disease (ulcerative colitis or Crohn's disease) - You have had prior pelvic radiation - You have certain rare connective tissue disorders (like ataxia telangiectasia or lupus) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMR-linac

1.5-Tesla MR-linac based SBRT


Locations(1)

Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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NCT05183074


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