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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adjuvant hypofractionated radiotherapy | Experimental | Patients after radical prostatectomy with high-risk pathological factors will receive hypofractionated post-prostatectomy radiotherapy in 15 fractions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Other | The patients after radical prostatectomy with high-risk pathological factors will receive adjuvant hypofractionated radiation therapy in 15 fractions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of radiotherapy-related gastrointestinal and genitourinary adverse events | Incidence of radiotherapy-related gastrointestinal and genitourinary adverse events | through study completion, an average of 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival (PFS) | including biochemical recurrence-free survival (bPFS) and radiological progression-free survival (RPFS) | Assessment progression-free survival (PFS) at 3 years |
| medical expenses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huojun Zhang, PhD | Contact | 021-31162222 | huojunzh@163.com | |
| Xianzhi Zhao, PhD | Contact | 021-31162222 | zhxzh0007@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Huojun Zhang, PhD | Changhai Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Naval Medical University | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
Individual participant data including baseline characteristics,treatment information and follow-up data on toxicity, survival and disease control will be shared.
Within 3 years after the publication of the study.
Data may be shared with radiation oncologists and specialists in surgery who are interested in examining the efficacy and toxicity of hypofractionated radiotherapy following radical prostatectomy. Detailed study protocol should be emailed along with the request of the data. We may carefully review the study protocol, and data will only be shared with well-designed studies.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Medical expenses include the cost of examination, hospitalisation, medication, radiation therapy, hospital equipment and any necessary follow-up treatment.
| 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. | through study completion, an average of 3 years |
| overall survival (OS) | To assess the overall survival (OS) | Assessment overall survival (OS) at 3 years |
| prostate cancer-specific survival (CSS) | To assess the prostate cancer-specific survival | Assessment prostate cancer-specific survival (CSS) at 3 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |