Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT06335693
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adjuvant Hypofractionated Radiotherapy for Prostate Cancer
Sponsor:
Changhai Hospital
Organization:
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 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).
Study Oversight
Has Oversight DMC:
True
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?: