Efficacy, High-risk, Prostate Cancer, Safety, Stereotactic Body Radiotherapy
Conditions
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.
Interventions
RADIATIONstereotactic 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.
Sponsors
West China Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| biochemical relapse-free survival | three months | 2-years biochemical relapse-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the incidence rate of acute toxicity | every week | the incidence rate of toxicity in 90 days |
| the incidence rate of late toxicity | three months | the incidence rate of toxicity after 90 days |
| patient-reported quality of life | three months | 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 | three months | 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. |
Countries
China
Contacts
Primary Contactxin wang, PhD/MD
Backup Contactfang wang
Outcome results
None listed