Prostate Cancer - Localized Adenocarcinoma Proton Therapy

Prostate Adenocarcinoma Clinical Trial

Official title:

A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With a Localized Prostate Adenocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03285815
• Other study ID #: NCC 2016-0120
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2017
• Last updated: September 15, 2017
• Start date: May 2016
• Est. completion date: December 2025

Study information

• Verified date: September 2017
• Source: National Cancer Center, Korea
• Contact: Kwanho Cho
• Phone: 82-31-920-1720
• Email: kwancho[@]ncc.re.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With A Localized Prostate Adenocarcinoma

Description:

For Proton therapy with prostate adenocarcinoma patients.

Arm 1: Proton therapy 3CGE x 20days = Total 60 CGE for 4 weeks.

Arm 2: Proton therapy 4.7CGE x 10days = Total 47 CGE for 2 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: December 2025
• Est. primary completion date: May 2024
• 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:0-1

• Signed study specific informed consent prior to study entry.

Exclusion Criteria:

• Postoperative residual or recurrent tumor

• Evidence of distant metastasis 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

Device:
• Proton Therapy

Locations

Country	Name	City	State
Korea, Republic of	Kwanho Cho	Ilsan	Gyenggi-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	BCFFS	To evaluate biochemical failure-free survival (BCFFS)	up to 5 years from a initial follow-up
Secondary	Acute/late toxicity (CTCAE v4.0)	Common Terminology Criteria for Adverse Events (CTCAE) V 4.0	up to 5 years from a initial follow-up
Secondary	Disease specific survival	follow-up	up to 5 years from a initial follow-up
Secondary	EPIC (Extended Prostate Cancer Index Composite)	questionnaire	up to 5 years from a initial follow-up