MR-linac Guided Ultra-hypofractionated RT for Prostate Cancer (SMART-P01 and SMART-P02) (SMART-P01/02)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

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

Treatments: Device: MR-linac

Study type: Interventional

Funder types: Other

Identifiers

NCT05183074

NCC2277

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

MR-linac group

Experimental group

Description:

Pts received ultra-hypofractionated RT for primary w/o adjacent oligo-metastatic diseases on 1.5-Tesla MR-Linac

Treatment:

Device: MR-linac