MR-linac Guided Ultra-hypofractionated RT for Prostate Cancer (SMART-P01 and SMART-P02)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

Contraindications to MRI.

TURP within the past 6 months

Ulcerative colitis, Crohn's Disease, ataxia telangiectasia, or systemic lupus erythematosus

Previous pelvic irradiation

Trial design

Treatments tested in this trial

  • MR-linac

Treatment groups

50 Participants
are divided into 1 treatment group