NCT06325995

Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer

Safety and Efficacy Study of Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer: a Randomized Controlled Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 428 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

The aim of this trial is to compare the safety outcomes of Hypofractionated postprostatectomy radiotherapy (HYPORT) and Conventionally fractionated postprostatectomy radiotherapy(COPORT) in treating patients with localized prostate cancer. Accumulating evidence has proven the safety and feasibility of HYPORT for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of HYPORT is still on its way. It is not yet known whether giving HYPORT(57.5-65 Gy in 23-26 daily fractions of 2.5 Gy ) with or COPORT may work better in treating patients with prostate cancer.

Detailed description

The present study will be conducted as a prospective, open-label, two arms clinical trial. Patients with pathologically confirmed prostate cancer and completed radical resection of prostate cancer, will be randomized in a 1:1 ratio between arm A (COPORT) and arm B (HYPORT). The patients in arm A will receive COPORT(66-74 Gy in 33-37 daily fractions of 2 Gy ). The patients in arm B will receive HYPORT(57.5-65 Gy in 23-26 daily fractions of 2.5 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 toxicities parameters.The secondary endpoints include ,progression-free survival (PFS),medical economics,quality of life (QoL), overall survival (OS)and prostate cancer-specific survival period. The progression-free survival (PFS) including biochemical progression-free survival (bPFS), and radiological progression-free survival.

Conditions

• Localized Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Conventional radiation therapy	66-74 Gy in 33-37 daily fractions of 2 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity.
RADIATION	Hypofractionated radiation therapy	57.5-65 Gy in 23-26 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity.

Timeline

• Start date: 2024-02-01
• Primary completion: 2026-02-01
• Completion: 2031-02-01
• First posted: 2024-03-22
• Last updated: 2024-08-26

Locations

1 site across 1 country: China