Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma

Prostate Adenocarcinoma Clinical Trial

Official title:

Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01709253
• Other study ID #: NCCCTS 07-253
• Status: Completed
• Phase: N/A
• First received: October 15, 2012
• Last updated: March 27, 2017
• Start date: March 2007
• Est. completion date: December 2015

Study information

• Verified date: March 2017
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 2 hypofractionation study usion proton beam therapy for prostate adenocarcinoma

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma
• Prostatic Neoplasms

Intervention

Radiation:
• proton beam therapy
hypofractionation study using proton beam therapy for prostate adenocarcinoma

Locations

Country	Name	City	State
Korea, Republic of	National cancer center, korea	Goyang-si	Gyeonggi-do,

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical outcomes	To evaluate biochemical failure-free survival (BCFFS)	up to 5years from a initial follow-up
Secondary	acute toxicity	to evaluate acute toxicities by CTCAE version 3.0	up to 5years from a initial follow-up
Secondary	late toxicity	to evaluated late toxicities by CTCAE version 3.0	up to 5years from a initial follow-up
Secondary	overall survival	to evaluated overall survival	up to 5years from a initial follow-up