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To determine if hypofractionated IG-VMAT (70 Gy in 28 fractions over 5.6 weeks) will result in disease-free survival (DFS) that is no worse than DFS following conventionally fractionated IG-VMAT (80Gy in 40 fractions over 8 weeks) in patients treated for localized prostate cancer. Analysis the local progression, disease-specific survival (DFS), freedom from biochemical recurrence (FFBR), and overall survival (OS) of two groups. Observe the incidence of GI and GU toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hypofraction | Experimental | 70 Gy in 28 fractions over 5.6 weeks |
|
| convention | Active Comparator | 80Gy in 40 fractions over 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hypofraction | Radiation | 70 Gy in 28 fractions over 5.6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical progression free survival | Number of participants who are free of biochemical relapse after a specified duration of time.Phoenix definition of biochemical failure. | up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of "acute" adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4.0 | From the start of radiation therapy (RT) to first occurrence of worse severity of adverse event within 30 days after the completion of RT | |
| Time to "late" grade 2+ adverse events as assessed by NCI CTCAE v. 4.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiuzi Zhong | Contact | +86 13810428903 | drzhongqiuzi@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Gaofeng Li, director | Beijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Recruiting | Beijing | China |
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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 |
|---|---|
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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| convention |
| Radiation |
80Gy in 40 fractions over 8 weeks |
|
| From the date of completion of RT to the date of first grade 2 or above adverse event occurring 30 days after the completion of RT |
| Overall Survival | up to 5 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |