Stereotactic Body Radiotherapy vs Intensity-modulated Radiotherapy in Prostate Cancer

Overview

The primary goal of this phase II study is to compare the change of EPIC HRQOL scores (1-year minus baseline) between SBRT and IMRT.

Full Title of Study: “A Randomized, Open Label, Phase II Study: Stereotactic Body Radiotherapy (SBRT) vs Conventional Intensity-modulated Radiotherapy (IMRT) for Low or Intermediate Risk Prostate Cancer in Asia Population”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2023

Interventions

  • Radiation: IMRT
  • Radiation: SBRT

Arms, Groups and Cohorts

  • Other: IMRT
    • Patients will receive 38 fractions of radiation, each fraction size will be 2Gy. The total dose will be 78Gy to PTV 1. Whereas the total dose will be 70Gy over 38 fractions to PTV 2. The treatment will be delivered 5 fractions per week consecutively except public holiday, and the total duration of treatment will be 7.5 to 8 weeks.
  • Other: SBRT
    • Patients will receive 5 fractions of radiation; each fraction size will be 7.25Gy. The total dose will be 36.25 Gy to PTV1. Whereas the total dose will be 32.5Gy over 5 fractions to PTV2. The 5 treatments will be scheduled to be delivered twice aweek over approximately 15-17 days. A minimum of 72 hours and a maximum of 96 hoursshould separate each treatment. No more than 2 fractions will be delivered per week. The total duration of treatment will be no shorter than 15 days and no longer than 17 days.

Clinical Trial Outcome Measures

Primary Measures

  • health-related quality of life (HRQOL)
    • Time Frame: 1 year

Secondary Measures

  • the rate of acute and late GI and GU toxicity
    • Time Frame: 5 years
  • biochemical-failure free survival
    • Time Frame: 5 years
  • disease-specific survival
    • Time Frame: 5 years
  • overall survival
    • Time Frame: 5 years

Participating in This Clinical Trial

Inclusion Criteria

  • Histological confirmation of prostate adenocarcinoma – Low or intermediate risk prostate cancer patients (i.e. T1-T2c and PSA 20 and Gleason score < 8) with the risk of pelvic node metastasis 15% as calculated by Roach's formula – ECOG performance score 0-1 – Age ≥ 18 – History/physical examination within 2 weeks prior to registration – Able to sign informed-consent Exclusion Criteria:

  • Patients with previous diagnosis of cancer other than prostate cancer and non-melanoma skin cancer. – Evidence of distant metastases – Regional lymph node involvement – Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer – Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy – Previous hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide) or LHRHantagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g.DES), or surgical castration (orchiectomy) – Unstable angina and/or congestive heart failure requiring hospitalization, transmural myocardial infarction within the last 6 months, acute bacterial or fungal infection requiring intravenous antibiotics, chronic obstructive pulmonary disease exacerbation or other respiratory illness requiringhospitalization or precluding study therapy at the time of registration – Patients who have received prior chemotherapy.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chinese University of Hong Kong
  • Provider of Information About this Clinical Study
    • Principal Investigator: CCTU, Comprehensive Clinical Trial Unit – Chinese University of Hong Kong

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