Prostate AdenocarcinomaNCT01709253
Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma
A study testing proton beam therapy in people with Prostate Adenocarcinoma, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
Phase 2 hypofractionation study usion proton beam therapy for prostate adenocarcinoma Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- proton beam therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2007to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Biopsy proven prostate adenocarcinoma Stage: T1-T2cN0M0 ECOG performance status: 0-2 Signed study specific informed consent prior to study entry
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
National cancer center, korea
Goyang-si, Gyeonggi-do, 411-769
About this study
Phase 2 hypofractionation study usion proton beam therapy for prostate adenocarcinoma
- Conditions
- Prostate Adenocarcinoma
- Being tested
- proton beam therapy
- Keywords
- hpofractionation study using proton beam therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proton beam therapyRadiation
hypofractionation study using proton beam therapy for prostate adenocarcinoma
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 27pt/60CGE/20fx/5wks to PGTV(mon, tue, thu, fri; 4/wk) Receives: Radiation: proton beam therapy |
| Arm 2 | Experimental | 27pt/54CGE/15fx/5wks to PGTV (mon, wed, fri; 3/wk) Receives: Radiation: proton beam therapy |
| Arm 3 | Experimental | 27pt / 47CGE/10fx/5wk to PGTV(tue, thu;2/wk) Receives: Radiation: proton beam therapy |
| Arm 4 | Experimental | 27pt/ 35CGE/ 5fx/2.5wk to PGTV(the, thu; 2/wk) Receives: Radiation: proton beam therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical outcomes
To evaluate biochemical failure-free survival (BCFFS)
Measured: up to 5years from a initial follow-up
Secondary outcomes (3)
acute toxicity
to evaluate acute toxicities by CTCAE version 3.0
Measured: up to 5years from a initial follow-up
late toxicity
to evaluated late toxicities by CTCAE version 3.0
Measured: up to 5years from a initial follow-up
overall survival
to evaluated overall survival
Measured: up to 5years from a initial follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startMar 2007
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kwan Ho Cho, National Cancer Center, Korea
- Investigators
- kwan ho cho, M.D., Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709253
- Sponsor's protocol ID
- NCCCTS 07-253
- Status last verified
- Mar 2017
- First submitted
- 15 Oct 2012
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma
- ClinicalTrials.gov ID
- NCT01709253
- Acronym / sponsor ID
- NCCCTS 07-253
- Conditions
- Prostate Adenocarcinoma
- Keywords
- hpofractionation study using proton beam therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Mar 2007
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2 hypofractionation study usion proton beam therapy for prostate adenocarcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Radiation: proton beam therapy27pt/60CGE/20fx/5wks to PGTV(mon, tue, thu, fri; 4/wk) |
| Arm 2 | Experimental | Radiation: proton beam therapy27pt/54CGE/15fx/5wks to PGTV (mon, wed, fri; 3/wk) |
| Arm 3 | Experimental | Radiation: proton beam therapy27pt / 47CGE/10fx/5wk to PGTV(tue, thu;2/wk) |
| Arm 4 | Experimental | Radiation: proton beam therapy27pt/ 35CGE/ 5fx/2.5wk to PGTV(the, thu; 2/wk) |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Biopsy proven prostate adenocarcinoma Stage: T1-T2cN0M0 ECOG performance status: 0-2 Signed study specific informed consent prior to study entry
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| proton beam therapyhypofractionation study using proton beam therapy for prostate adenocarcinoma | Radiation | Arm 1, Arm 2, Arm 3, Arm 4 |
Primary outcome
clinical outcomes
Time frame: up to 5years from a initial follow-up
To evaluate biochemical failure-free survival (BCFFS)
3 secondary outcomes
acute toxicity
Time frame: up to 5years from a initial follow-up
late toxicity
Time frame: up to 5years from a initial follow-up
overall survival
Time frame: up to 5years from a initial follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Derived from this study: PubMed 30630500Ha 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
kwan ho cho, M.D. principal investigator
National Cancer Center, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing proton beam therapy in people with Prostate Adenocarcinoma, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical outcomes (time frame: up to 5years from a initial follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01709253, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.