A Phase II Clinical Study of Stereotactic Radiation Therapy in Patients With High-risk Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Phase II Clinical Study of Stereotactic Radiation Therapy Based on Multiparameter Magnetic Resonance Image in Patients With High-risk Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05430737
• Other study ID #: SBRT-PCa-001
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2022
• Source: West China Hospital
• Contact: xin wang, PhD/MD
• Phone: +86 28 85423609
• Email: wangxin213[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Efficacy
• High-risk
• Prostate Cancer
• Prostatic Neoplasms
• Safety
• Stereotactic Body Radiotherapy

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
China	China, SiChuan	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	biochemical relapse-free survival	2-years biochemical relapse-free survival	three months
Secondary	the incidence rate of acute toxicity	the incidence rate of toxicity in 90 days	every week
Secondary	the incidence rate of late toxicity	the incidence rate of toxicity after 90 days	three months
Secondary	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.	three months
Secondary	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.	three months