Stereotactic Body Radiotherapy vs Intensity-modulated Radiotherapy in Prostate Cancer

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: SBRT; Radiation: IMRT

• Registration Number: NCT02339701
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-07
• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-01-13
• Study First Posted: 2015-01-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-24
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 68

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SBRT	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.
IMRT	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.

Primary Outcome Measures

Name	Time	Method
health-related quality of life (HRQOL)	1 year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Clinical Oncology, Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong