Stereotactic Body Radiotherapy vs Intensity-modulated Radiotherapy in Prostate Cancer

The Chinese University of Hong Kong

Status: Active, not recruiting

Conditions: Prostate Cancer

Treatments: Radiation: SBRT; Radiation: IMRT

Study type: Interventional

Funder types: Other

Identifiers

NCT02339701

PST005

Details and patient eligibility

About

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.

Enrollment: 68 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

IMRT

Other group

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.

Treatment:

Radiation: IMRT

SBRT

Other group

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.

Treatment:

Radiation: SBRT