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The aim of this trial is to study the safety outcomes of hypofractionated radiotherapy in treating patients with localized prostate cancer.
Hypofractionated radiotherapy delivers higher doses of radiotherapy in a shorter time period, may enabling the killing of more tumor cells with fewer side effects.
Accumulating evidence has proven the safety and feasibility of hypofractionated radiotherapy for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of hypofractionated radiotherapy is still on its way.
The present study will be conducted as a prospective, open-label, single-arm clinical trial.
The patients will receive hypofractionated radiation(54 Gy in 15 daily fractions of 3.6 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 the toxicities about gastrointestinal (GI),genitourinary (GU) symptoms and erectile dysfunction.The secondary endpoints include progression-free survival (bPFS), local progression-free-survival(LPFS) ,distant metastasis free survival(DMFS) ,overall survival (OS)and quality of life (QoL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated Radiotherapy | Experimental | Hypofractionated Radiotherapy over 3 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated radiation therapy | Radiation | 54 Gy in 15 daily fractions of 3.6 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 | RTOG / EORTC scale, Common Terminology Criteria for Adverse Events (CTCAE) 5.0, erectile dysfunction. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| biochemical progression-free survival (bPFS) | The definition of biochemical failure is a PSA measurement ≥ PSA nadir + 2 ng/mL where nadir is the lowest post-RT PSA value.Time to biochemical failure is defined as time from randomization to the date of first biochemical failure, last known follow-up (censored), or death without biochemical failure (competing risk). | 5 years |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40257456 | Derived | Liang Y, Zhang W, Zhao X, Zhang H. Hypofractionated radiotherapy for localized prostate cancer: the protocol for a prospective clinical trial. Future Oncol. 2025 May;21(12):1483-1488. doi: 10.1080/14796694.2025.2489340. Epub 2025 Apr 21. |
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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 surgerywho are interested in examining the efficacy and toxicity of localized prostate cancer treated with radical hypofractionated radiotherapy. 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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| local progression-free-survival(LPFS) | Response evaluation criteria in solid tumor(RECIST)1.1:To determine the outcome of treatment for solid tumors,The efficacy according the diameter of the lesion could be divided into complete response(CR),partial response(PR),stable disease(SD)and progressive disease(PD). | 5 years |
| distant metastasis free survival(DMFS) | Distant metastasis (failure) is defined as radiographic evidence of hematogenous spread evaluated by bone scan, CT, or MRI. Time to distant metastasis is defined as time from randomization to the date of first distant metastasis, last known follow-up (censored), or death without local recurrence (competing risk). | 5 years |
| Overall survival (OS) | Overall survival time is defined as time from registration/randomization to the date of death (failure) from any cause or last known follow-up (censored). | 5 years |
| Quality of life (QoL) | 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. | 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 | 5 years |