NCT05430737

A Phase II Clinical Study of Stereotactic Radiation Therapy in Patients With High-risk Prostate Cancer

A Phase II Clinical Study of Stereotactic Radiation Therapy Based on Multiparameter Magnetic Resonance Image in Patients With High-risk Prostate Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

Stereotactic body radiotherapy (SBRT) has emerged as an effective and safe treatment for low and intermediate-risk prostate cancer(PCa). However, there is no study that has investigated the effectiveness and safety of SBRT with pelvic radiation and gross target volume(GTV) boost for high-risk prostate cancer patients yet. The investigators designed a phase II clinical study of SBRT with pelvic radiation and GTV boost based on mpMRI in patients with high-risk prostate cancer.

Conditions

• Prostate Cancer
• Stereotactic Body Radiotherapy
• High-risk
• Efficacy
• Safety

Interventions

Type	Name	Description
RADIATION	stereotactic body radiotherapy	The radiation dose to the primary tumor was 40 or 45 Gy in five fractions according to the clinical determination of the radiologist. The dose to the positive lymph nodes and the prostate and seminal vesicles was 37.5Gy in five fraction. And internal iliac, external iliac, obturator, and presacral pelvic drainage regions received 25 Gy/5f, simultaneously. The treatment was delivered every other day. The volumetric modulated arc radiotherapy (VMAT) or intensity-modulated radiotherapy (IMRT) was used to complete treatment. Image-guided radiotherapy(IGRT) was performed for every treatment.

Timeline

• Start date: 2022-06-30
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2022-06-24
• Last updated: 2022-06-24

Locations

1 site across 1 country: China