NCT06335693

Adjuvant Hypofractionated Radiotherapy for Prostate Cancer

Safety and Efficacy Study of Adjuvant Hypofractionated Radiotherapy Following Radical Prostatectomy for Prostate Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hypofractionated radiation therapy is a new type of radiotherapy which has been shown to play a larger role in the treatment of prostate cancer. The aims of the trial were to evaluate the safety and feasibility of adjuvant hypofractionated radiotherapy following radical prostatectomy for prostate cancer.

Detailed description

The present study will be conducted as a prospective, prospective, single-centre, single-arm clinical trial. Patients after radical prostatectomy with high-risk pathological factors will receive hypofractionated post-prostatectomy radiotherapy in 15 fractions. The primary endpoint of the study is incidence of radiotherapy-related gastrointestinal and genitourinary adverse events,judging by (CTCAE)5.0. The secondary endpoints are progression-free survival (PFS) including biochemical recurrence-free survival (bPFS) and radiological progression-free survival (RPFS), economic evaluations, self-assessment of quality of life including Abbreviated Version of the Expanded Prostate Cancer In-dex Composite Instrument (EPIC-26) and Physical Activity Rank Scale-3 (ARS-3), overall survival (OS) and prostate cancer-specific survival (CSS).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	Radiotherapy	The patients after radical prostatectomy with high-risk pathological factors will receive adjuvant hypofractionated radiation therapy in 15 fractions.

Timeline

• Start date: 2024-03-28
• Primary completion: 2026-02-28
• Completion: 2027-02-28
• First posted: 2024-03-28
• Last updated: 2024-03-28

Locations

1 site across 1 country: China