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

Sichuan University

Status: Enrolling

Conditions: Efficacy; High-risk; Prostate Cancer; Stereotactic Body Radiotherapy; Safety

Treatments: Radiation: stereotactic body radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05430737

SBRT-PCa-001

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

stereotactic body radiotherapy

Experimental group

Description:

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.

Treatment:

Radiation: stereotactic body radiotherapy