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The aim of this trial is to compare the safety outcomes of Hypofractionated postprostatectomy radiotherapy (HYPORT) and Conventionally fractionated postprostatectomy radiotherapy(COPORT) in treating patients with localized prostate cancer.
Accumulating evidence has proven the safety and feasibility of HYPORT for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of HYPORT is still on its way.
It is not yet known whether giving HYPORT(57.5-65 Gy in 23-26 daily fractions of 2.5 Gy ) with or COPORT may work better in treating patients with prostate cancer.
The present study will be conducted as a prospective, open-label, two arms clinical trial.
Patients with pathologically confirmed prostate cancer and completed radical resection of prostate cancer, will be randomized in a 1:1 ratio between arm A (COPORT) and arm B (HYPORT).
The patients in arm A will receive COPORT(66-74 Gy in 33-37 daily fractions of 2 Gy ). The patients in arm B will receive HYPORT(57.5-65 Gy in 23-26 daily fractions of 2.5 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 toxicities parameters.The secondary endpoints include ,progression-free survival (PFS),medical economics,quality of life (QoL), overall survival (OS)and prostate cancer-specific survival period. The progression-free survival (PFS) including biochemical progression-free survival (bPFS), and radiological progression-free survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (COPORT) | Active Comparator | COPORT over 7 weeks. |
|
| B(HYPORT) | Experimental | HYPORT over 5 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional radiation therapy | Radiation | 66-74 Gy in 33-37 daily fractions of 2 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events | Common Terminology Criteria for Adverse Events (CTCAE) 5.0 | Assessment toxicities parameters at 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year progression-free survival (PFS) | To assess progression-free survival (PFS) including biochemical progression-free survival (bPFS), and radiological progression-free survival. | Assessment progression-free survival (PFS) at 5 years |
| quality of life (QoL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huojun Zhang | Contact | 021-31162222 | huojunzh@163.com | |
| Xianzhi Zhao | Contact | 021-31162222 | zhxzh0007@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai hospital | 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 5 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 localized prostate cancer treated with HYPORT or COPORT. 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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| Hypofractionated radiation therapy | Radiation | 57.5-65 Gy in 23-26 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. |
|
Expanded Prostate Cancer Index (EPIC-26):The EPIC is a prostate cancer health-related quality of life (HRQOL) self-administered instrument measuring patient-reported urinary, bowel, sexual, and hormonal symptoms related to prostate cancer treatments. Response options for each item form a Likert scale with scores transformed linearly to a 0-100 scale. Domain scores are also on a 0-100 scale with higher scores representing better HRQOL. |
| through study completion, an average of 5 years |
| medical expenses | The medical expenses during the time of interventions.The medical expenses include the payments of doctor and hospital visits, co-pays, radiotherapy and so on. | Assessment the medical economics during the treatment,up to 7 weeks |
| Overall survival (OS) | To assess the overall survival (OS) | Assessment overall survival (OS) at 5 years |
| Prostate cancer-specific survival | To assess the prostate cancer-specific survival | Assessment prostate cancer-specific survival at 5 years |
| Physical Activity Rank Scale-3 (ARS-3) | To assess the physical activity rank.The scale was compiled by Japanese psychologist KIMIO HASHIMOTO and introduced and revised by Liang Deqing from Wuhan Physical Education University. There are only 3 items in this scale, which adopts 5 grades from 1 to 5, and examines the level of physical activity from 3 aspects: intensity, time and frequency of participating in physical activity. | through study completion, an average of 5 years |