Prostate Cancer - Localized Adenocarcinoma Proton Therapy

National Cancer Center (NCC)

Status: Enrolling

Conditions: Prostate Adenocarcinoma

Treatments: Device: Proton Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03285815

NCC 2016-0120

Details and patient eligibility

About

A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With A Localized Prostate Adenocarcinoma

Full description

For Proton therapy with prostate adenocarcinoma patients.

Arm 1: Proton therapy 3CGE x 20days = Total 60 CGE for 4 weeks.

Arm 2: Proton therapy 4.7CGE x 10days = Total 47 CGE for 2 weeks.

Enrollment: 156 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Biopsy proven prostate adenocarcinoma Stage: T1-T2cN0M0
• ECOG performance status:0-1
• Signed study specific informed consent prior to study entry.

Exclusion criteria

• Postoperative residual or recurrent tumor
• Evidence of distant metastasis previous irradiation for the tumor in the same location
• Adjuvant anti-androgenic hormonal therapy High risk group (NCCN guide line)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 2 patient groups

Proton Therapy 60 CGE

Experimental group

Description:

60 CGE (3CGE X 20) for 4wks

Treatment:

Device: Proton Therapy

Proton Therapy 47 CGE

Experimental group

Description:

47 CGE (4.7CGE X 10) for 2wks

Treatment:

Device: Proton Therapy