Back to resultsA Phase II Clinical Study of Stereotactic Radiation Therapy in Patients With High-risk Prostate Cancer
Primary Purpose
Prostate Cancer, Stereotactic Body Radiotherapy, High-risk
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
stereotactic body radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- 18 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
Exclusion Criteria:
- 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
Sites / Locations
- China, SiChuanRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
stereotactic body radiotherapy
Arm Description
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.
Outcomes
Primary Outcome Measures
biochemical relapse-free survival
2-years biochemical relapse-free survival
Secondary Outcome Measures
the incidence rate of acute toxicity
the incidence rate of toxicity in 90 days
the incidence rate of late toxicity
the incidence rate of toxicity after 90 days
patient-reported quality of life
patient-reported quality of life using European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30(EORTC QLQ C30) .The The minimum and maximum values of EORTC QLQ C30 are 0 and 100,respectively.Higher scores for functional and overall health areas of EORTC QLQ C30 indicate better functional status and quality of life, and higher scores for symptom areas indicate more symptoms or problems.
symptom score
Symptom score using the International Prostatic System Score (IPSS) .The minimum and maximum values of IPSS are 0 and 35,respectively.A higher score of IPSS means a poorer quality of life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05430737
Brief Title
A Phase II Clinical Study of Stereotactic Radiation Therapy in Patients With High-risk Prostate Cancer
Official Title
A Phase II Clinical Study of Stereotactic Radiation Therapy Based on Multiparameter Magnetic Resonance Image in Patients With High-risk Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2022 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Stereotactic Body Radiotherapy, High-risk, Efficacy, Safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
stereotactic body radiotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
stereotactic body radiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
biochemical relapse-free survival
Description
2-years biochemical relapse-free survival
Time Frame
three months
Secondary Outcome Measure Information:
Title
the incidence rate of acute toxicity
Description
the incidence rate of toxicity in 90 days
Time Frame
every week
Title
the incidence rate of late toxicity
Description
the incidence rate of toxicity after 90 days
Time Frame
three months
Title
patient-reported quality of life
Description
patient-reported quality of life using European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30(EORTC QLQ C30) .The The minimum and maximum values of EORTC QLQ C30 are 0 and 100,respectively.Higher scores for functional and overall health areas of EORTC QLQ C30 indicate better functional status and quality of life, and higher scores for symptom areas indicate more symptoms or problems.
Time Frame
three months
Title
symptom score
Description
Symptom score using the International Prostatic System Score (IPSS) .The minimum and maximum values of IPSS are 0 and 35,respectively.A higher score of IPSS means a poorer quality of life.
Time Frame
three months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xin wang, PhD/MD
Phone
+86 28 85423609
Email
wangxin213@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
fang wang
Phone
17342338589
Email
17342338589@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xin wang
Organizational Affiliation
China, SiChuan West China Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China, SiChuan
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xin Wang, PhD/MD
Phone
+86 28 85423609
Email
wangxin213@sina.com
First Name & Middle Initial & Last Name & Degree
fang Wang
Phone
17342338589
Email
17342338589@163.com
12. IPD Sharing Statement
Learn more about this trial
A Phase II Clinical Study of Stereotactic Radiation Therapy in Patients With High-risk Prostate Cancer
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