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Clinical Trials/NCT05430737
NCT05430737
Recruiting
N/A

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

West China Hospital1 site in 1 country60 target enrollmentJune 30, 2022
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ConditionsProstate CancerStereotactic Body RadiotherapyHigh-riskEfficacySafety

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
West China Hospital
Enrollment
60
Locations
1
Primary Endpoint
biochemical relapse-free survival
Status
Recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 30, 2022
End Date
June 30, 2025
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wang Xin

Professor

West China Hospital

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

Outcomes

Primary Outcomes

biochemical relapse-free survival

Time Frame: three months

2-years biochemical relapse-free survival

Secondary Outcomes

  • 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 Sites (1)

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