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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
The patients after radical prostatectomy with high-risk pathological factors will receive adjuvant hypofractionated radiation therapy in 15 fractions.
The First Affiliated Hospital of Naval Medical University
Shanghai, Shanghai Municipality, China
RECRUITINGIncidence of radiotherapy-related gastrointestinal and genitourinary adverse events
Incidence of radiotherapy-related gastrointestinal and genitourinary adverse events
Time frame: through study completion, an average of 3 years
progression-free survival (PFS)
including biochemical recurrence-free survival (bPFS) and radiological progression-free survival (RPFS)
Time frame: Assessment progression-free survival (PFS) at 3 years
medical expenses
Medical expenses include the cost of examination, hospitalisation, medication, radiation therapy, hospital equipment and any necessary follow-up treatment.
Time frame: through study completion, an average of 3 years
quality of life(QoL)
Expanded Prostate Cancer In-dex Composite Instrument 26 (EPIC-26) assesses 26 items in 5 areas, including urinary incontinence, urethral irritation and urethral obstruction symptoms, bowel function, sexual function, sexuality and sex hormone levels. The total score ranges from 0 to 100, with higher scores indicating better quality of life.
Time frame: through study completion, an average of 3 years
overall survival (OS)
To assess the overall survival (OS)
Time frame: Assessment overall survival (OS) at 3 years
prostate cancer-specific survival (CSS)
To assess the prostate cancer-specific survival
Time frame: Assessment prostate cancer-specific survival (CSS) at 3 years
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