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

Not Applicable

Recruiting

• Conditions: Prostate Cancer; Stereotactic Body Radiotherapy; Safety; High-risk; Efficacy
• Interventions: Radiation: stereotactic body radiotherapy

• Registration Number: NCT05430737
• Lead Sponsor: West China Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-26
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-18
• Last Update Submitted: 2022-06-18
• Study First Posted: 2022-06-24
• Last Update Posted: 2022-06-24
• Study Start: 2022-06-30
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
stereotactic body radiotherapy	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.

Primary Outcome Measures

Name	Time	Method
biochemical relapse-free survival	three months	2-years biochemical relapse-free survival

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

China, SiChuan; 🇨🇳 Chengdu, Sichuan, China