Prostate AdenocarcinomaNCT03285815
Prostate Cancer - Localized Adenocarcinoma Proton Therapy
A study testing Proton Therapy in people with Prostate Adenocarcinoma, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With A Localized 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 Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2016to Dec 2025
- 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:0-1
- Signed study specific informed consent prior to study entry.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kwanho Cho
Ilsan, Gyenggi-do
Kwanho Cho, 82-31-920-1720, kwancho@ncc.re.kr
Taehyun Kim
About this study
Official title: A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With a Localized Prostate Adenocarcinoma
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.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Proton Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton TherapyDevice
| Study group | Role | What they receive |
|---|---|---|
| Proton Therapy 60 CGE | Experimental | 60 CGE (3CGE X 20) for 4wks Receives: Device: Proton Therapy |
| Proton Therapy 47 CGE | Experimental | 47 CGE (4.7CGE X 10) for 2wks Receives: Device: Proton Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCFFS
To evaluate biochemical failure-free survival (BCFFS)
Measured: up to 5 years from a initial follow-up
Secondary outcomes (3)
Acute/late toxicity (CTCAE v4.0)
Common Terminology Criteria for Adverse Events (CTCAE) V 4.0
Measured: up to 5 years from a initial follow-up
Disease specific survival
follow-up
Measured: up to 5 years from a initial follow-up
EPIC (Extended Prostate Cancer Index Composite)
questionnaire
Measured: up to 5 years 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 Sep 2017
- Study startMay 2016
- Primary completionMay 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 156 participants (estimated)
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
- Kwanho Cho, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285815
- Sponsor's protocol ID
- NCC 2016-0120
- Status last verified
- Sep 2017
- First submitted
- 12 Sep 2017
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With a Localized Prostate Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03285815
- Acronym / sponsor ID
- NCC 2016-0120
- Conditions
- Prostate Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- May 2016
- Primary completion
- May 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Sep 2017 (actual)
- 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.
A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With A Localized Prostate Adenocarcinoma
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proton Therapy 60 CGE | Experimental | Device: Proton Therapy60 CGE (3CGE X 20) for 4wks |
| Proton Therapy 47 CGE | Experimental | Device: Proton Therapy47 CGE (4.7CGE X 10) for 2wks |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Biopsy proven prostate adenocarcinoma Stage: T1-T2cN0M0
- ECOG performance status:0-1
- Signed study specific informed consent prior to study entry.
Key exclusion criteria (3 listed)
- 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)
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 Therapy | Device | Proton Therapy 47 CGE, Proton Therapy 60 CGE |
Primary outcome
BCFFS
Time frame: up to 5 years from a initial follow-up
To evaluate biochemical failure-free survival (BCFFS)
3 secondary outcomes
Acute/late toxicity (CTCAE v4.0)
Time frame: up to 5 years from a initial follow-up
Disease specific survival
Time frame: up to 5 years from a initial follow-up
EPIC (Extended Prostate Cancer Index Composite)
Time frame: up to 5 years from a initial follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- Individual participant dataSharing planned: No
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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.
Kwanho Cho 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 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kwanho Cho (82-31-920-1720, kwancho@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCFFS (time frame: up to 5 years 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?
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 18 Sep 2017.