RadiotherapyNCT04724577
12 Fractions Carbon Ion Radiotherapy for Localized Prostate Cancer
A study testing carbon ion radiotherapy in people with Radiotherapy and Prostate Cancer, run by Shanghai Proton and Heavy Ion Center at 1 site in China.
Trial summary
The arm of this study is to explore the optimal dose of 12 fractions of carbon ion radiotherapy for prostate cancer in our center. Read more about this study
- Who is it for?
- Ages 45 to 85 years, men only
- Conditions the study is for
- Radiotherapy, Prostate Cancer
- What is being tested?
- carbon ion radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 1 Jun 2023
- 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 45 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed adenocarcinoma of prostate
- Stage cT1-3N0M0 localized prostate cancer
- No lymph nodes or distant metastasis
- Age ≥ 45 and < 85 years of age
- Karnofsky Performance Score ≥70
- No previous pelvic radiation therapy (RT)
Show all 10Show fewer
- No previous prostatectomy
- No previous invasive cancer (within 5 years before the prostate cancer diagnosis)
- Ability to understand character and individual consequences of the clinical trial
- Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial
Who cannot join
- No pathologically confirmed adenocarcinoma of the prostate
- Pelvic lymph node metastasis (N1)
- Distant metastasis (M1)
- Previous pelvic radiotherapy
- Previous prostatectomy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Proton and Heavy Ion Center
Shanghai
Ping Li, 38296666, ping.li@sphic.org.cn
Qing Zhang, 38296666, qing.zhang@sphic.org.cn
About this study
Official title: Phase I Study on Carbon Ion Radiotherapy in 12 Fractions for Localized Prostate Cancer
The arm of this study is to explore the optimal dose of 12 fractions of carbon ion radiotherapy for prostate cancer in our center.
Read the detailed description
The radiation dose of 51.6GyE in 12 fractions is currently widely used in Japan, and clinical studies of 51.6GyE/12Fx have also been carried out for SBRT. There are some differences in equipment and carbon ion treatment planning system used between Japan and our center. Therefore, we designed this phase I clinical study to explore the optimal dose of 12 fractions of carbon ion radiotherapy for prostate cancer.
- Conditions
- Radiotherapy, Prostate Cancer
- Being tested
- carbon ion radiotherapy
- Keywords
- localized prostate cancer, carbon ion radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbon ion radiotherapyRadiation
dose escalation radiotherapy with five levels of dose from 54GyE/12Fx to 58.8GyE/12Fx
| Study group | Role | What they receive |
|---|---|---|
| Carbon ion treatment | Experimental | dose escalation study with five dose levels [54GGyE(Gray equivalent)/12Fx,55.2GyE/12Fx,56.4GyE/12Fx,57.6GyE/12Fx and 58.8GyE/12Fx ]. Receives: Radiation: carbon ion radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute toxicity
Treatment related acute toxicity assessed by CTCAE v4.03
Measured: 3 months after the completion of CIRT
Secondary outcomes (3)
Biochemical failure free survival,bFFS
The PSA less than nadir plus 2ng/ml
Measured: From the complation of CIRT,a median of 5 years
Overall survival
The time from diagnosis to death from any cause
Measured: From the diagnosis of prostate cancer,a median of 5 years
Progression free survival
The time from complation of CIRT to tumor progression or death
Measured: From the complation of CIRT,a median of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start1 Dec 2019
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiotherapyStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- dose escalation study for carbon ion radiotherapy in prostate cancer
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Proton and Heavy Ion Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Li, Shanghai Proton and Heavy Ion Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724577
- Sponsor's protocol ID
- SPHIC-TR-PCa2019-01
- Status last verified
- Nov 2021
- First submitted
- 23 Jan 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study on Carbon Ion Radiotherapy in 12 Fractions for Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT04724577
- Acronym / sponsor ID
- SPHIC-TR-PCa2019-01
- Conditions
- Radiotherapy, Prostate Cancer
- Keywords
- localized prostate cancer, carbon ion radiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Proton and Heavy Ion CenterUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 26 Jan 2021 (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.
The arm of this study is to explore the optimal dose of 12 fractions of carbon ion radiotherapy for prostate cancer in our center.
Detailed description
The radiation dose of 51.6GyE in 12 fractions is currently widely used in Japan, and clinical studies of 51.6GyE/12Fx have also been carried out for SBRT. There are some differences in equipment and carbon ion treatment planning system used between Japan and our center. Therefore, we designed this phase I clinical study to explore the optimal dose of 12 fractions of carbon ion radiotherapy for prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- dose escalation study for carbon ion radiotherapy in prostate cancer
| Arm | Type | Receives |
|---|---|---|
| Carbon ion treatment | Experimental | Radiation: carbon ion radiotherapydose escalation study with five dose levels [54GGyE(Gray equivalent)/12Fx,55.2GyE/12Fx,56.4GyE/12Fx,57.6GyE/12Fx and 58.8GyE/12Fx ]. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pathologically confirmed adenocarcinoma of prostate
- Stage cT1-3N0M0 localized prostate cancer
- No lymph nodes or distant metastasis
- Age ≥ 45 and < 85 years of age
- Karnofsky Performance Score ≥70
Key exclusion criteria (5 listed)
- No pathologically confirmed adenocarcinoma of the prostate
- Pelvic lymph node metastasis (N1)
- Distant metastasis (M1)
- Previous pelvic radiotherapy
- Previous prostatectomy
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 |
|---|---|---|
| carbon ion radiotherapydose escalation radiotherapy with five levels of dose from 54GyE/12Fx to 58.8GyE/12Fx | Radiation | Carbon ion treatment |
Primary outcome
Acute toxicity
Time frame: 3 months after the completion of CIRT
Treatment related acute toxicity assessed by CTCAE v4.03
3 secondary outcomes
Biochemical failure free survival,bFFS
Time frame: From the complation of CIRT,a median of 5 years
Overall survival
Time frame: From the diagnosis of prostate cancer,a median of 5 years
Progression free survival
Time frame: From the complation of CIRT,a median of 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carbon ion radiotherapy in people with Radiotherapy and Prostate Cancer, run by Shanghai Proton and Heavy Ion Center at 1 site in China.
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 10 inclusion and 5 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 19 Nov 2021. 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 China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute toxicity (time frame: 3 months after the completion of CIRT). 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 19 Nov 2021.