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

June 18, 2022 updated by: Wang Xin, West China Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • China, Sichuan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
biochemical relapse-free survival
Time Frame: three months
2-years biochemical relapse-free survival
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence rate of acute toxicity
Time Frame: every week
the incidence rate of toxicity in 90 days
every week
the incidence rate of late toxicity
Time Frame: three months
the incidence rate of toxicity after 90 days
three months
patient-reported quality of life
Time Frame: 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.
three months
symptom score
Time Frame: 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.
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 30, 2022

Primary Completion (ANTICIPATED)

June 30, 2025

Study Completion (ANTICIPATED)

June 30, 2025

Study Registration Dates

First Submitted

May 26, 2022

First Submitted That Met QC Criteria

June 18, 2022

First Posted (ACTUAL)

June 24, 2022

Study Record Updates

Last Update Posted (ACTUAL)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 18, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBRT-PCa-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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