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

This trial tests MR‑guided, very short-course high‑dose radiation for men with localized or limited metastatic prostate cancer to see if it is tolerable and effective.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05183074 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Men aged 18 or older with histologically confirmed localized prostate cancer (including selected low-, intermediate-, and some high‑risk cases) or prostate in‑situ with limited oligometastatic disease, who have ECOG 0–2, prostate volume ≤100 cc, IPSS <18, and can undergo MRI and provide informed consent.

Not a fit: Patients with contraindications to MRI, recent TURP within 6 months, active ulcerative colitis or Crohn's disease, ataxia telangiectasia, systemic lupus erythematosus, very poor performance status, or otherwise ineligible per protocol are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could shorten treatment to a few high‑dose visits while maintaining cancer control and potentially reducing some side effects compared with longer courses of radiation.

How similar studies have performed: Other centers have reported promising early tolerance and disease control with MR‑guided SBRT for prostate cancer, but the combination of MR‑guided simultaneous boosts and integrated biomarker–mpMRI correlation is relatively novel.

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

Where this trial is running

Beijing, Beijing Municipality

• Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Ning-Ning Lu

Conditions: Prostate Cancer, Radiotherapy Side Effect, Magnetic Resonance-linac, Stereotactic Ablative RT, Adaptive Radiotherapy, Localised Disease, Oligometastatic Disease