NCT03285815

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 18, 2017

Status Verified

September 1, 2017

Enrollment Period

8 years

First QC Date

September 12, 2017

Last Update Submit

September 15, 2017

Conditions

Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • BCFFS

    To evaluate biochemical failure-free survival (BCFFS)

    up to 5 years from a initial follow-up

Secondary Outcomes (3)

  • Acute/late toxicity (CTCAE v4.0)

    up to 5 years from a initial follow-up

  • Disease specific survival

    up to 5 years from a initial follow-up

  • EPIC (Extended Prostate Cancer Index Composite)

    up to 5 years from a initial follow-up

Study Arms (2)

Proton Therapy 60 CGE

EXPERIMENTAL

60 CGE (3CGE X 20) for 4wks

Device: Proton Therapy

Proton Therapy 47 CGE

EXPERIMENTAL

47 CGE (4.7CGE X 10) for 2wks

Device: Proton Therapy

Interventions

Proton TherapyDEVICE
Proton Therapy 47 CGEProton Therapy 60 CGE

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:0-1
  • Signed study specific informed consent prior to study entry.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kwanho Cho

Ilsan, Gyenggi-do, South Korea

RECRUITING

MeSH Terms

Interventions

Proton Therapy

Intervention Hierarchy (Ancestors)

Heavy Ion RadiotherapyRadiotherapyTherapeutics

Study Officials

  • Kwanho Cho

    National Cancer Center, Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kwanho Cho

CONTACT

82-31-920-1720kwancho@ncc.re.kr

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
Principal Investigator

Study Record Dates

First Submitted

September 12, 2017

First Posted

September 18, 2017

Study Start

May 1, 2016

Primary Completion

May 1, 2024

Study Completion

December 1, 2025

Last Updated

September 18, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)