Stereotactic Body Radiotherapy vs Intensity-modulated Radiotherapy in Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02339701
• Other study ID #: PST005
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 7, 2015
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 68
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• IMRT

• SBRT

Locations

Country	Name	City	State
Hong Kong	Department of Clinical Oncology, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	health-related quality of life (HRQOL)		1 year
Secondary	the rate of acute and late GI and GU toxicity		5 years
Secondary	biochemical-failure free survival		5 years
Secondary	disease-specific survival		5 years
Secondary	overall survival		5 years