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Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma

Primary Purpose

Prostate Adenocarcinoma

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

proton beam therapy

About this trial

This is an interventional treatment trial for Prostate Adenocarcinoma focused on measuring hpofractionation study using proton beam therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept 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)

Sites / Locations

National cancer center, korea

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

clinical outcomes

To evaluate biochemical failure-free survival (BCFFS)

Secondary Outcome Measures

acute toxicity

to evaluate acute toxicities by CTCAE version 3.0

late toxicity

to evaluated late toxicities by CTCAE version 3.0

overall survival

to evaluated overall survival

Full Information

NCT ID

NCT01709253

First Posted

October 15, 2012

Last Updated

March 27, 2017

Sponsor

National Cancer Center, Korea

1. Study Identification

Unique Protocol Identification Number

NCT01709253

Brief Title

Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma

Official Title

Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Cancer Center, Korea

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Phase 2 hypofractionation study usion proton beam therapy for prostate adenocarcinoma

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Adenocarcinoma

Keywords

hpofractionation study using proton beam therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

117 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

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

Arm Title

Arm 2

Arm Type

Experimental

Arm Description

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

Arm Title

Arm 3

Arm Type

Experimental

Arm Description

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

Arm Title

Arm 4

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

proton beam therapy

Intervention Description

hypofractionation study using proton beam therapy for prostate adenocarcinoma

Primary Outcome Measure Information:

Title

clinical outcomes

Description

To evaluate biochemical failure-free survival (BCFFS)

Time Frame

up to 5years from a initial follow-up

Secondary Outcome Measure Information:

Title

acute toxicity

Description

to evaluate acute toxicities by CTCAE version 3.0

Time Frame

up to 5years from a initial follow-up

Title

late toxicity

Description

to evaluated late toxicities by CTCAE version 3.0

Time Frame

up to 5years from a initial follow-up

Title

overall survival

Description

to evaluated overall survival

Time Frame

up to 5years from a initial follow-up

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

kwan ho cho, M.D.

Organizational Affiliation

National Cancer Center, Korea

Official's Role

Principal Investigator

Facility Information:

Facility Name

National cancer center, korea

City

Goyang-si

State/Province

Gyeonggi-do,

ZIP/Postal Code

411-769

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

30630500

Citation

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.

Results Reference

derived

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Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma

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