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Status unknownNCT03285815Updated Sep 18, 2017

Prostate Cancer - Localized Adenocarcinoma Proton Therapy

An interventional study of Proton Therapy in Prostate Adenocarcinoma, sponsored by National Cancer Center, Korea. Status unknown at 1 site in South Korea. Open to male participants. Per ClinicalTrials.gov, last updated 2017-09-18.

Sponsored by National Cancer Center, Korea · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
156
Allocation
Randomized
Sex
Male
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Prostate Adenocarcinoma
03

In context

Lead sponsor

National Cancer Center, Korea is the lead sponsor of 203 studies on the registry; 36 are open to participants now.

Browse National Cancer Center, Korea studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
156 participants (estimated)

Study arms

  • Experimental
    Proton Therapy 60 CGE

    60 CGE (3CGE X 20) for 4wks

    Device: Proton Therapy

  • Experimental
    Proton Therapy 47 CGE

    47 CGE (4.7CGE X 10) for 2wks

    Device: Proton Therapy

Interventions

  • DeviceProton Therapy
06

What researchers measure

Primary outcomes

  1. BCFFS

    To evaluate biochemical failure-free survival (BCFFS)

    Time frame: up to 5 years from a initial follow-up

Secondary outcomes

  1. Acute/late toxicity (CTCAE v4.0)

    Common Terminology Criteria for Adverse Events (CTCAE) V 4.0

    Time frame: up to 5 years from a initial follow-up

  2. Disease specific survival

    follow-up

    Time frame: up to 5 years from a initial follow-up

  3. EPIC (Extended Prostate Cancer Index Composite)

    questionnaire

    Time frame: up to 5 years from a initial follow-up

07

Study locations

1 of 1 sites recruiting
  • Kwanho Cho
    Ilsan, Gyenggi-do, South Korea
    • Kwanho Cho · Contact · kwancho@ncc.re.kr · 82-31-920-1720
    • Taehyun Kim · Sub investigator
    • Yeonjoo Kim · Sub investigator
    • Kanghyun Lee · Sub investigator
    • Youngkyung Lim · Sub investigator
    • Jaeyoung Jung · Sub investigator
    • Byungho Nam · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2016, a primary completion of May 2024 and a completion of Dec 2025. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2017
First posted
Sep 18, 2017
Start
May 2016
Primary completionEst.
May 2024
CompletionEst.
Dec 2025
Last update
Sep 18, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03285815
Lead sponsor
National Cancer Center, Korea
Responsible party
Kwan Ho Cho (Principal Investigator, National Cancer Center, Korea) — Principal investigator
First posted
Sep 18, 2017
Start date
May 2016
Primary completion
May 2024 (estimated)
Completion
Dec 2025 (estimated)
Last update
Sep 18, 2017

Study contacts

Kwanho Cho
Contact
kwancho@ncc.re.kr
82-31-920-1720
Kwanho Cho
principal investigator · National Cancer Center, Korea

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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