Stereotactic Body Radiotherapy vs Intensity-modulated Radiotherapy in Prostate Cancer

NCT ID: NCT02339701

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-07

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

IMRT

Intervention Type RADIATION

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.

Group Type OTHER

SBRT

Intervention Type RADIATION

Interventions

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IMRT

Intervention Type RADIATION

SBRT

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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CCTU

Comprehensive Clinical Trial Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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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.

Reference Type DERIVED
PMID: 35049677 (View on PubMed)

Other Identifiers

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PST005

Identifier Type: -

Identifier Source: org_study_id

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