A Phase II Clinical Study of Stereotactic Radiation Therapy in Patients With High-risk Prostate Cancer
NCT ID: NCT05430737
Last Updated: 2022-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2022-06-30
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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stereotactic body radiotherapy
Long-term ADT of 2-3years were administered. Neoadjuvant ADT within 6 months was allowed.Then patients with high-risk prostate cancer recieve stereotactic body radiotherapy with pelvic radiation and GTV boost based on multiparameter magnetic resonance image.
stereotactic body radiotherapy
The radiation dose to the primary tumor was 40 or 45 Gy in five fractions according to the clinical determination of the radiologist. The dose to the positive lymph nodes and the prostate and seminal vesicles was 37.5Gy in five fraction. And internal iliac, external iliac, obturator, and presacral pelvic drainage regions received 25 Gy/5f, simultaneously. The treatment was delivered every other day. The volumetric modulated arc radiotherapy (VMAT) or intensity-modulated radiotherapy (IMRT) was used to complete treatment. Image-guided radiotherapy(IGRT) was performed for every treatment.
Interventions
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stereotactic body radiotherapy
The radiation dose to the primary tumor was 40 or 45 Gy in five fractions according to the clinical determination of the radiologist. The dose to the positive lymph nodes and the prostate and seminal vesicles was 37.5Gy in five fraction. And internal iliac, external iliac, obturator, and presacral pelvic drainage regions received 25 Gy/5f, simultaneously. The treatment was delivered every other day. The volumetric modulated arc radiotherapy (VMAT) or intensity-modulated radiotherapy (IMRT) was used to complete treatment. Image-guided radiotherapy(IGRT) was performed for every treatment.
Eligibility Criteria
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Inclusion Criteria
* pathologically confirmed high-risk (T3a or Gleason score ≥ 8 or a PSA \> 20 ng/ml) prostate cancer
* a WHO performance status 0-1
* history of neoadjuvant androgen deprivation therapy(ADT) within 6 months before enrollment
* Patients with pelvic positive lymph node were also included in our study
Exclusion Criteria
* history of neoadjuvant ADT over 6 months before enrollment
* history of definitive treatment for prostate cancer such as radical prostatectomy
* history of pelvic irradiation; prostate volume≥100 cm3
18 Years
95 Years
MALE
No
Sponsors
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West China Hospital
OTHER
Responsible Party
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Wang Xin
Professor
Principal Investigators
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xin wang
Role: PRINCIPAL_INVESTIGATOR
China, SiChuan West China Hospital
Locations
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China, SiChuan
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SBRT-PCa-001
Identifier Type: -
Identifier Source: org_study_id
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