NCT06325774

Radical Hypofractionated Radiotherapy for Localized Prostate Cancer

Safety and Efficacy Study of Hypofractionated Radiotherapy for Localized Prostate Cancer: a Single-arm Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this trial is to study the safety outcomes of hypofractionated radiotherapy in treating patients with localized prostate cancer. Hypofractionated radiotherapy delivers higher doses of radiotherapy in a shorter time period, may enabling the killing of more tumor cells with fewer side effects. Accumulating evidence has proven the safety and feasibility of hypofractionated radiotherapy for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of hypofractionated radiotherapy is still on its way.

Detailed description

The present study will be conducted as a prospective, open-label, single-arm clinical trial. The patients will receive hypofractionated radiation(54 Gy in 15 daily fractions of 3.6 Gy ). After completion of study treatment, patients were followed up once a month for the first 3 months and once every 3 months after 3 months for a total of 5 years. The primary endpoints of the study are the toxicities about gastrointestinal (GI),genitourinary (GU) symptoms and erectile dysfunction.The secondary endpoints include progression-free survival (bPFS), local progression-free-survival(LPFS) ,distant metastasis free survival(DMFS) ,overall survival (OS)and quality of life (QoL).

Conditions

• Localized Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Hypofractionated radiation therapy	54 Gy in 15 daily fractions of 3.6 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity.

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-09-01
• Completion: 2031-09-01
• First posted: 2024-03-22
• Last updated: 2024-08-26

Locations

1 site across 1 country: China