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

Recruiting
18 - 95 years of age
Male
Phase N/A

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Overview

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.

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

Study details

Prostate Cancer, Stereotactic Body Radiotherapy, High-risk, Efficacy, Safety

NCT05430737

West China Hospital

25 January 2024

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