Clinical trial · Interventional
Stereotactic Body Radiotherapy vs Intensity-modulated Radiotherapy in Prostate Cancer
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
NCT02339701CI-TRIAL-00097268active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMRT | Radiation | — | UNRESOLVED |
| SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- IMRT
- 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.
- interventionNames
- Radiation: IMRT
- type
- OTHER
- label
- SBRT
- 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.
- interventionNames
- Radiation: SBRT
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDLam BHW, Chan EKH, Wong OL, Chan CF, Chen ACC, Chan LL, Johnson DR, Lam DCM, Wong KCW, Suen JJS, Poon DMC. Comparative real-world analysis of stereotactic body radiotherapy versus conventional radiotherapy for Chinese patients with low- to intermediate-risk localised prostate cancer. Hong Kong Med J. 2026 Jun;32(3):234-242. doi: 10.12809/hkmj2514055. Epub 2026 Jun 15. PMID 42290063
- DERIVEDPoon 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. PMID 35049677