Back to resultsStereotactic Body Radiotherapy vs Intensity-modulated Radiotherapy in Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Active
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
IMRT
SBRT
Sponsored by
About this trial
This is an interventional health services research trial for Prostate Cancer
Eligibility Criteria
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.
Sites / Locations
- Department of Clinical Oncology, Prince of Wales Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
IMRT
SBRT
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
health-related quality of life (HRQOL)
Secondary Outcome Measures
the rate of acute and late GI and GU toxicity
biochemical-failure free survival
disease-specific survival
overall survival
Full Information
NCT ID
NCT02339701
First Posted
January 13, 2015
Last Updated
April 20, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT02339701
Brief Title
Stereotactic Body Radiotherapy vs Intensity-modulated Radiotherapy in Prostate Cancer
Official Title
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
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 7, 2015 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IMRT
Arm Type
Other
Arm Description
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.
Arm Title
SBRT
Arm Type
Other
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
IMRT
Intervention Type
Radiation
Intervention Name(s)
SBRT
Primary Outcome Measure Information:
Title
health-related quality of life (HRQOL)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
the rate of acute and late GI and GU toxicity
Time Frame
5 years
Title
biochemical-failure free survival
Time Frame
5 years
Title
disease-specific survival
Time Frame
5 years
Title
overall survival
Time Frame
5 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Department of Clinical Oncology, Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Citations:
PubMed Identifier
35049677
Citation
Poon DMC, Lam D, Wong KCW, Chu CM, Cheung M, Mo F, Suen J, Ng CF, Chan ATC. Prospective Randomized Phase II Study of Stereotactic Body Radiotherapy (SBRT) vs. Conventional Fractionated Radiotherapy (CFRT) for Chinese Patients with Early-Stage Localized Prostate Cancer. Curr Oncol. 2021 Dec 22;29(1):27-37. doi: 10.3390/curroncol29010003.
Results Reference
derived
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Stereotactic Body Radiotherapy vs Intensity-modulated Radiotherapy in Prostate Cancer
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