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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • MR-linac

    Device

    1.5-Tesla MR-linac based SBRT

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: MR-linac groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The Incidence of Acute GU and GI toxicities: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Time frame
Three months post-MRL-SBRT

Secondary outcomes

1

The Incidence of Late toxicities: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Time frame
6-months, 1-year and 2-year
2

Quality of life evaluation

Evaluate quality of life of patients by QOL questionnaires at different time points

Time frame
Every 2 weeks during SBRT and till 8 weeks after RT completion, every 3 months to 2 years and every 6 months to 5 years, and yearly thereafter
3

Biochemical-relapse free survival

Time frame
2-year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.