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Active, not recruitingNCT02339701Updated Nov 17, 2025

Stereotactic Body Radiotherapy vs Intensity-modulated Radiotherapy in Prostate Cancer

An interventional study of IMRT and SBRT in Prostate Cancer, sponsored by Chinese University of Hong Kong. Active, not recruiting at 1 site in Hong Kong. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-17.

Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years and older
Sex
Male
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Study 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.

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Conditions studied

  • Prostate Cancer

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03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 68 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
68 participants (estimated)

Study arms

  • Other
    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.

    Radiation: IMRT

  • Other
    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.

    Radiation: SBRT

Interventions

  • RadiationIMRT
  • RadiationSBRT
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What researchers measure

Primary outcomes

  1. health-related quality of life (HRQOL)

    Time frame: 1 year

Secondary outcomes

  1. the rate of acute and late GI and GU toxicity

    Time frame: 5 years

  2. biochemical-failure free survival

    Time frame: 5 years

  3. disease-specific survival

    Time frame: 5 years

  4. overall survival

    Time frame: 5 years

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Study locations

1 site
  • Department of Clinical Oncology, Prince of Wales Hospital
    Hong Kong, Hong Kong
08

References and documents

Publications

  • Lam 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. PubMed 42290063 ↗
  • 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. PubMed 35049677 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02339701
Lead sponsor
Chinese University of Hong Kong
Responsible party
CCTU (Comprehensive Clinical Trial Unit, Chinese University of Hong Kong) — Principal investigator
First posted
Jan 15, 2015
Start date
Jan 7, 2015
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Nov 17, 2025

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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