Prostate Cancer
Conditions
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.
Interventions
RADIATIONIMRT
RADIATIONSBRT
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| health-related quality of life (HRQOL) | 1 year |
Secondary
| Measure | 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 |
Countries
Hong Kong
Outcome results
None listed