MR‑guided short-course high-dose radiation for prostate cancer (SMART‑P01 & P02)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants receive MR‑linac guided stereotactic ablative radiotherapy delivered in a small number of high‑dose sessions with adaptive planning on the machine before or during treatment. The protocol may include a simultaneous higher‑dose boost to MRI‑visible tumor foci when feasible. Investigators will record acute and late side effects, cancer control outcomes, and patient quality of life, and will collect blood and tissue samples alongside mp‑MRI before and after treatment. Correlations between imaging changes and biomarker dynamics will be explored to identify predictors of persistent or recurrent disease.

Why it matters

Who can join: the full rules

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

Where it's running

• Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Ning-Ning Lu
• Email: Ning-Ning.Lu@hotmail.com
• Phone: +868611804268

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Single‑fraction versus multiple‑fraction SBRT for treating limited metastases (SPRINT)

  This trial will test whether a single high‑dose SBRT treatment works as safely and effectively as multiple smaller SBRT treatments for people with limited metastases from breast, prostate, lung, or colorectal cancer.

  Recruiting at 2 sites European Organisation for Research and Treatment of Cancer - EORTC · Aalst and 14 other locations · NCT06462963

• Adaptive ultra-short radiation therapy for early prostate cancer

  This study tests how well ultra-hypofractionated adaptive radiation therapy works for men with early prostate cancer and how it affects their quality of life.

  Recruiting Jena University Hospital · Jena · NCT06355050

• Comparing two types of radiation therapy for prostate cancer treatment

  This study is testing whether a new type of radiation therapy for prostate cancer works better and is safer than a different method, while also looking at how well the treatment is tolerated by patients.

  Recruiting CHU de Quebec-Universite Laval · Québec · NCT05786742

• Treatment for recurrent prostate cancer with metastases

  This study is testing whether combining hormone therapy with targeted radiation or surgery can help men with recurrent prostate cancer live longer without their cancer spreading.

  Recruiting Phase 3 Universitaire Ziekenhuizen KU Leuven · Leuven · NCT05352178

• Improving treatment for prostate cancer with metastases at diagnosis

  This study is testing if adding a special type of radiation therapy to standard treatment helps men with newly diagnosed prostate cancer that has spread feel better and live longer.

  Recruiting at 10 sites Phase 2 University of Maryland, Baltimore · La Jolla, California and 9 other locations · NCT05223803

• Testing different radiation schedules for metastatic prostate cancer

  This study is testing whether a more intense radiation schedule works better and causes fewer side effects for people with newly diagnosed metastatic prostate cancer.

  Recruiting Umeå University · Umeå · NCT04612907

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.