Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335693
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-17
Brief Title:
Adjuvant Hypofractionated Radiotherapy for Prostate Cancer
Sponsor:
Changhai Hospital
Organization:
Changhai Hospital
Study Overview
Official Title:
Safety and Efficacy Study of Adjuvant Hypofractionated Radiotherapy Following Radical Prostatectomy for Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-03
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:
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 eventsjudging by CTCAE50 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
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