NCT01709253

Brief Summary

Phase 2 hypofractionation study usion proton beam therapy for prostate adenocarcinoma

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

8.8 years

First QC Date

October 15, 2012

Last Update Submit

March 27, 2017

Conditions

Prostate Adenocarcinoma

Keywords

hpofractionation study using proton beam therapy

Outcome Measures

Primary Outcomes (1)

  • clinical outcomes

    To evaluate biochemical failure-free survival (BCFFS)

    up to 5years from a initial follow-up

Secondary Outcomes (3)

  • acute toxicity

    up to 5years from a initial follow-up

  • late toxicity

    up to 5years from a initial follow-up

  • overall survival

    up to 5years from a initial follow-up

Study Arms (4)

Arm 1

EXPERIMENTAL

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

Radiation: proton beam therapy

Arm 2

EXPERIMENTAL

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

Radiation: proton beam therapy

Arm 3

EXPERIMENTAL

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

Radiation: proton beam therapy

Arm 4

EXPERIMENTAL

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

Radiation: proton beam therapy

Interventions

proton beam therapyRADIATION

hypofractionation study using proton beam therapy for prostate adenocarcinoma

Arm 1Arm 2Arm 3Arm 4

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National cancer center, korea

Goyang-si, Gyeonggi-do, 411-769, South Korea

Location

Related Publications (1)

  • Ha B, Cho KH, Lee KH, Joung JY, Kim YJ, Lee SU, Kim H, Suh YG, Moon SH, Lim YK, Jeong JH, Kim H, Park WS, Kim SH. Long-term results of a phase II study of hypofractionated proton therapy for prostate cancer: moderate versus extreme hypofractionation. Radiat Oncol. 2019 Jan 10;14(1):4. doi: 10.1186/s13014-019-1210-7.

    PMID: 30630500DERIVED

MeSH Terms

Interventions

Proton Therapy

Intervention Hierarchy (Ancestors)

Heavy Ion RadiotherapyRadiotherapyTherapeutics

Study Officials

  • kwan ho cho, M.D.

    National Cancer Center, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

October 15, 2012

First Posted

October 18, 2012

Study Start

March 1, 2007

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 29, 2017

Record last verified: 2017-03

Locations

KR(1)