Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325995
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-02
Brief Title:
Hypofractionated Post-prostatectomy Radiotherapy HYPORTfor Localized Prostate Cancer
Sponsor:
Changhai Hospital
Organization:
Changhai Hospital
Study Overview
Official Title:
Safety and Efficacy Study of Hypofractionated Post-prostatectomy Radiotherapy HYPORTfor Localized Prostate Cancer a Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this trial is to compare the safety outcomes of Hypofractionated postprostatectomy radiotherapy HYPORT and Conventionally fractionated postprostatectomy radiotherapyCOPORT in treating patients with localized prostate cancer
Accumulating evidence has proven the safety and feasibility of HYPORT for localized prostate cancerBut for localized prostate cancerthe optimal dose per fraction of HYPORT is still on its way
It is not yet known whether giving HYPORT575-65 Gy in 23-26 daily fractions of 25 Gy with or COPORT may work better in treating patients with prostate cancer
Accumulating evidence has proven the safety and feasibility of HYPORT for localized prostate cancerBut for localized prostate cancerthe optimal dose per fraction of HYPORT is still on its way
It is not yet known whether giving HYPORT575-65 Gy in 23-26 daily fractions of 25 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 11 ratio between arm A COPORT and arm B HYPORT
The patients in arm A will receive COPORT66-74 Gy in 33-37 daily fractions of 2 Gy The patients in arm B will receive HYPORT575-65 Gy in 23-26 daily fractions of 25 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 parametersThe secondary endpoints include progression-free survival PFSmedical economicsquality of life QoL overall survival OSand prostate cancer-specific survival period The progression-free survival PFS including biochemical progression-free survival bPFS and radiological progression-free survival
Patients with pathologically confirmed prostate cancer and completed radical resection of prostate cancer will be randomized in a 11 ratio between arm A COPORT and arm B HYPORT
The patients in arm A will receive COPORT66-74 Gy in 33-37 daily fractions of 2 Gy The patients in arm B will receive HYPORT575-65 Gy in 23-26 daily fractions of 25 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 parametersThe secondary endpoints include progression-free survival PFSmedical economicsquality of life QoL overall survival OSand prostate cancer-specific survival period The progression-free survival PFS including biochemical progression-free survival bPFS and radiological progression-free survival
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None