Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01709253

Enrollment

117

Registered

2012-10-18

Start date

2007-03-31

Completion date

2015-12-31

Last updated

2017-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Adenocarcinoma

Keywords

hpofractionation study using proton beam therapy

Brief summary

Phase 2 hypofractionation study usion proton beam therapy for prostate adenocarcinoma

Interventions

RADIATIONproton beam therapy

hypofractionation study using proton beam therapy for prostate adenocarcinoma

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

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)

Design outcomes

Primary

Measure	Time frame	Description
clinical outcomes	up to 5years from a initial follow-up	To evaluate biochemical failure-free survival (BCFFS)

Secondary

Measure	Time frame	Description
acute toxicity	up to 5years from a initial follow-up	to evaluate acute toxicities by CTCAE version 3.0
late toxicity	up to 5years from a initial follow-up	to evaluated late toxicities by CTCAE version 3.0
overall survival	up to 5years from a initial follow-up	to evaluated overall survival

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026