Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325774
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-16
Brief Title:
Radical Hypofractionated Radiotherapy for Localized Prostate Cancer
Sponsor:
Changhai Hospital
Organization:
Changhai Hospital
Study Overview
Official Title:
Safety and Efficacy Study of Hypofractionated Radiotherapy for Localized Prostate Cancer a Single-arm 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 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 cancerBut for localized prostate cancerthe optimal dose per fraction of hypofractionated radiotherapy is still on its way
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 cancerBut for localized prostate cancerthe 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 radiation54 Gy in 15 daily fractions of 36 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 GIgenitourinary GU symptoms and erectile dysfunctionThe secondary endpoints include progression-free survival bPFS local progression-free-survivalLPFS distant metastasis free survivalDMFS overall survival OSand quality of life QoL
The patients will receive hypofractionated radiation54 Gy in 15 daily fractions of 36 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 GIgenitourinary GU symptoms and erectile dysfunctionThe secondary endpoints include progression-free survival bPFS local progression-free-survivalLPFS distant metastasis free survivalDMFS overall survival OSand quality of life QoL
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