A Phase II Clinical Study of Stereotactic Radiation Therapy in Patients With High-risk Prostate Cancer
1 other identifier
interventional
60
1 country
1
Brief Summary
Stereotactic body radiotherapy (SBRT) has emerged as an effective and safe treatment for low and intermediate-risk prostate cancer(PCa). However, there is no study that has investigated the effectiveness and safety of SBRT with pelvic radiation and gross target volume(GTV) boost for high-risk prostate cancer patients yet. The investigators designed a phase II clinical study of SBRT with pelvic radiation and GTV boost based on mpMRI in patients with high-risk prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable prostate-cancer
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2022
CompletedFirst Posted
Study publicly available on registry
June 24, 2022
CompletedStudy Start
First participant enrolled
June 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedJune 24, 2022
June 1, 2022
3 years
May 26, 2022
June 18, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
biochemical relapse-free survival
2-years biochemical relapse-free survival
three months
Secondary Outcomes (4)
the incidence rate of acute toxicity
every week
the incidence rate of late toxicity
three months
patient-reported quality of life
three months
symptom score
three months
Study Arms (1)
stereotactic body radiotherapy
EXPERIMENTALLong-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.
Interventions
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
You may qualify if:
- years or older
- 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
You may not qualify if:
- distant metastasis
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China, SiChuan
Chengdu, Sichuan, 610041, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
xin wang
China, SiChuan West China Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 26, 2022
First Posted
June 24, 2022
Study Start
June 30, 2022
Primary Completion
June 30, 2025
Study Completion
June 30, 2025
Last Updated
June 24, 2022
Record last verified: 2022-06