NCT02339701

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
20mo left

Started Jan 2015

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Jan 2015Dec 2027

Study Start

First participant enrolled

January 7, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2015

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

12 years

First QC Date

January 13, 2015

Last Update Submit

November 13, 2025

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • health-related quality of life (HRQOL)

    1 year

Secondary Outcomes (4)

  • 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

Study Arms (2)

IMRT

OTHER

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

SBRT

OTHER

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

IMRTRADIATION
IMRT
SBRTRADIATION
SBRT

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

  • 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.

    PMID: 35049677DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Comprehensive Clinical Trial Unit

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 15, 2015

Study Start

January 7, 2015

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

November 17, 2025

Record last verified: 2025-11

Locations

HK(1)