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This study is the first prospective, randomized phase III clinical trial designed to evaluate whether ultrahypofractionated radiotherapy is non-inferior to conventionally moderately hypofractionated radiotherapy in terms of efficacy, with acceptable toxicity, in patients who develop biochemical recurrence following radical prostatectomy.
Considering the potential clinical benefits of shorter treatment duration, cost reduction, and improved patient convenience, this study is expected to provide important evidence to optimize salvage radiotherapy strategies in routine clinical practice.
Moderate hypofractionated radiotherapy (Moderate-hypoRT): 60 Gy in 24 fractions, delivered once daily, 5 days per week (on weekdays), over a total of 5-6 weeks.
Ultra-hypofractionated radiotherapy (Ultra-hypoRT): 31 Gy in 5 fractions, delivered every other day (2-3 fractions per week), over a total of 2 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate hypofractionated radiotherapy (Moderate-hypoRT) | Active Comparator |
| |
| Ultra-hypofractionated radiotherapy (Ultra-hypoRT) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate hypofractionated radiotherapy (Moderate-hypoRT) | Radiation | Moderate hypofractionated radiotherapy (Moderate-hypoRT): 60 Gy in 24 fractions (administered once daily on weekdays, five times per week, over a total of 5-6 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year biochemical progression-free survival (bPFS) | 5 years after treatment completion |
| Measure | Description | Time Frame |
|---|---|---|
| Analyze Distant Metastasis-Free Survival (DMFS) | 5 years after treatment completion | |
| Cancer-Specific Survival (CSS) | 5 years after treatment completion | |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Won Park | Contact | +82-10-9933-2616 | wonro.park@samsung.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | Gangnam-gu | 06351 | South Korea |
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| Ultra-hypofractionated radiotherapy (Ultra-hypoRT) | Radiation | Ultra-hypofractionated radiotherapy (Ultra-hypoRT): 31 Gy in 5 fractions (administered every other day, 2-3 times per week, over a total of 2 weeks). |
|
| 5 years after treatment completion |
| Compare acute and late Genitourinary (GU) and Gastrointestinal (GI) toxicities. | 5 years after treatment completion |
| Compare patient-reported Quality of Life (QoL) outcomes | During treatment and follow-up |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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