Stereotactic Body Radiotherapy vs Intensity-modulated Radiotherapy in Prostate Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: IMRT
* Radiation: SBRT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: IMRT<br>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. | Radiation: IMRT<br> <br> |
| Other: SBRT<br>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. | Radiation: SBRT<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health-related quality of life (HRQOL) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of acute and late GI and GU toxicity |  | 5 years | 
| biochemical-failure free survival |  | 5 years | 
| disease-specific survival |  | 5 years | 
| overall survival |  | 5 years |