MR-linac Guided Ultra-hypofractionated RT for Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Phase II Prospective Trial of MR-linac Based Stereotactic Ablative Radiotherapy for Patients With Localized and Oligo-metastatic Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05183074
• Other study ID #: NCC2277
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: January 31, 2024

Study information

• Verified date: December 2021
• Source: Chinese Academy of Medical Sciences
• Contact: Ning-Ning Lu
• Phone: +868611804268
• Email: Ning-Ning.Lu[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oligometastatic Disease
• Prostate Cancer
• Prostatic Neoplasms
• Radiotherapy Side Effect

Intervention

Device:
• MR-linac
1.5-Tesla MR-linac based SBRT

Locations

Country	Name	City	State
China	Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Three months post-MRL-SBRT
Secondary	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	6-months, 1-year and 2-year
Secondary	Quality of life evaluation	Evaluate quality of life of patients by QOL questionnaires at different time points	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
Secondary	Biochemical-relapse free survival		2-year