Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma

National Cancer Center (NCC)

Status: Completed

Conditions: Prostate Adenocarcinoma

Treatments: Radiation: proton beam therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01709253

NCCCTS 07-253

Details and patient eligibility

About

Phase 2 hypofractionation study usion proton beam therapy for prostate adenocarcinoma

Enrollment: 117 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

Biopsy proven prostate adenocarcinoma Stage: T1-T2cN0M0 ECOG performance status: 0-2 Signed study specific informed consent prior to study entry

Exclusion criteria

Postoperative residual or recurrent tumor Evidence of distant metastases 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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117 participants in 4 patient groups

Arm 1

Experimental group

Description:

27pt/60CGE/20fx/5wks to PGTV(mon, tue, thu, fri; 4/wk)

Treatment:

Radiation: proton beam therapy

Arm 2

Experimental group

Description:

27pt/54CGE/15fx/5wks to PGTV (mon, wed, fri; 3/wk)

Treatment:

Radiation: proton beam therapy

Arm 3

Experimental group

Description:

27pt / 47CGE/10fx/5wk to PGTV(tue, thu;2/wk)

Treatment:

Radiation: proton beam therapy

Arm 4

Experimental group

Description:

27pt/ 35CGE/ 5fx/2.5wk to PGTV(the, thu; 2/wk)

Treatment:

Radiation: proton beam therapy