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CompletedNCT01709253Updated Mar 29, 2017

Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma

An interventional study of proton beam therapy in Prostate Adenocarcinoma, sponsored by National Cancer Center, Korea. Completed at 1 site in South Korea. Open to male participants. Per ClinicalTrials.gov, last updated 2017-03-29.

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

Phase
Not applicable
Study type
Interventional
Enrollment
117
Allocation
Randomized
Sex
Male
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Study summary

Phase 2 hypofractionation study usion proton beam therapy for prostate adenocarcinoma

02

Conditions studied

  • Prostate Adenocarcinoma

Keywords

  • hpofractionation study using proton beam therapy
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In context

Lead sponsor

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

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

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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: 0-2 Signed study specific informed consent prior to study entry

Exclusion criteria

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)

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Study design

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

Study arms

  • Experimental
    Arm 1

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

    Radiation: proton beam therapy

  • Experimental
    Arm 2

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

    Radiation: proton beam therapy

  • Experimental
    Arm 3

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

    Radiation: proton beam therapy

  • Experimental
    Arm 4

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

    Radiation: proton beam therapy

Interventions

  • Radiationproton beam therapy

    hypofractionation study using proton beam therapy for prostate adenocarcinoma

06

What researchers measure

Primary outcomes

  1. clinical outcomes

    To evaluate biochemical failure-free survival (BCFFS)

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

Secondary outcomes

  1. acute toxicity

    to evaluate acute toxicities by CTCAE version 3.0

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

  2. late toxicity

    to evaluated late toxicities by CTCAE version 3.0

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

  3. overall survival

    to evaluated overall survival

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

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Study locations

1 site
  • National cancer center, korea
    Goyang-si, Gyeonggi-do 411-769, South Korea
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References and documents

Publications

  • 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. PubMed 30630500 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01709253
Responsible party
Kwan Ho Cho (M.D., National Cancer Center, Korea) — Principal investigator
First posted
Oct 18, 2012
Start date
Mar 2007
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Mar 29, 2017

Study contacts

kwan ho cho, M.D.
principal investigator · National Cancer Center, Korea

Oversight

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

Not currently enrolling

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

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