Prostate CancerNCT05106699
Carbon Ion Followed by Proton Radiotherapy for Prostate Cancer With Pelvic Lymph Nodes Metastases
A study testing proton plus carbon ion radiation in people with Prostate Cancer, run by Shanghai Proton and Heavy Ion Center at 1 site in China.
Trial summary
The present of clinically pelvic lymph node positive (cN1) represent one of the most important prognostic factors for recurrence and cancer-specific mortality of prostate cancer patients. Approximately 12% of prostate cancer patients present with cN1 disease at the time of diagnosis. Read more about this study
- Who is it for?
- Ages 45 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- proton plus carbon ion radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2021to 31 May 2026
- 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
- Histologically proven initial diagnosis of adenocarcinoma of the prostate;
- Clinical stage T1-4 N0 M0;
- Prostatic assessment by multiparametric (mp) MRI;
- Pelvic lymph node was assessed by PSMA PET/CT and mpMRI;
- No distant metastasis was proven by PSMA PET/CT;
- Patients may received neoadjuvant hormonal therapy;
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- 45≤ Age ≤85;
- Adequate performance status (ECOG 0-1);
- No previous pelvic radiation therapy (RT);
- 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;
- Written informed consent;
Who cannot join
- No pathologically confirmed adenocarcinoma of the prostate;
- 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, +86-021-38296666, ping.li@sphic.org.cn
Qing Zhang, qing.zhang@sphic.org.cn
About this study
Official title: Carbon Ion Boost Followed by Pelvic Proton Radiotherapy for Prostate Cancer With Pelvic Lymph Nodes Metastases: Prospective Phase II Study
The present of clinically pelvic lymph node positive (cN1) represent one of the most important prognostic factors for recurrence and cancer-specific mortality of prostate cancer patients. Approximately 12% of prostate cancer patients present with cN1 disease at the time of diagnosis. Furthermore, with the advent of more sensitive advance diagnostic imaging techniques, such as PSMA PET/CT, the likelihood that pelvic nodes will be found earlier and more frequently.
Unfortunately, The optimal treatment for patients with cN1 still remains unclear. Androgen deprivation therapy (ADT) is the cornerstone of prostate cancer with pelvic lymph node metastasis. Some retrospective and database studies have shown that addition of local radiotherapy (RT) to ADT improve the treatment outcome. The 2022 NCCN guideline recommend RT combined with 2 to 3 years ADT in patients with initially diagnosed cN1 prostate cancer who have a life expectancy greater than 5 years.
- Conditions
- Prostate Cancer
- Being tested
- proton plus carbon ion radiation
- Keywords
- Carbon ion, Proton, prostate cancer, pelvic lymph nodes metastases
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proton plus carbon ion radiationRadiation
All patients received whole pelvis and prostate region proton irradiation of 46 GyE in 23 fractionsfollowed by localized carbon ion irradiation of 32GyE in 8 fractions to the prostate region. The dose to metastatic LN was escalated using simultaneous integrated boost (SIB) technique. The dose was 60-62.1GyE in 23 fractions as much as dose constraints. All patients will be recommened receive 2-3 years endocrine therapy.
| Study group | Role | What they receive |
|---|---|---|
| Carbon ion followed by Proton radiotherapy | Experimental | All patients received whole pelvis and prostate region radiotherapy. The dose to metastatic LN was escalated using simultaneous integrated boost (SIB) technique. Receives: Radiation: proton plus carbon ion radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical relapse free survival
The prostate specific antigen less than nadir plus 2ng/ml (Phoenix definition)
Measured: From the start of systemic therapy, a median of 3 years
Secondary outcomes (5)
Progression free survival
The time from start of systemic therapy to tumor progression or death
Measured: From the start of systemic therapy, a median of 3 years
Overall survival
The time from diagnosis to death from any cause
Measured: From the start of systemic therapy, a median of 3 years
Metastasis free survival
The time from start of systemic therapy to tumor metastatsis.
Measured: From the start of systemic therapy, a median of 3 years
Acute toxicities
Treatment related acute toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Measured: Within 3 months of the start of particle therapy
Late toxicities
Treatment related late toxicity assessed by Radiation Therapy Oncology Group (RTOG) scale
Measured: 3 months after the completion of particle therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start8 Jun 2021
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Masking
- None (open label)
- Enrolment
- 54 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
- Investigators
- Qing Zhang, M.D., Study director, Shanghai Proton and Heavy Ion Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106699
- Sponsor's protocol ID
- SPHIC-TR-PCa2021-01
- Status last verified
- Jun 2021
- First submitted
- 24 Oct 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbon Ion Boost Followed by Pelvic Proton Radiotherapy for Prostate Cancer With Pelvic Lymph Nodes Metastases: Prospective Phase II Study
- ClinicalTrials.gov ID
- NCT05106699
- Acronym / sponsor ID
- SPHIC-TR-PCa2021-01
- Conditions
- Prostate Cancer
- Keywords
- Carbon ion, Proton, prostate cancer, pelvic lymph nodes metastases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Shanghai Proton and Heavy Ion CenterUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 4 Nov 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 present of clinically pelvic lymph node positive (cN1) represent one of the most important prognostic factors for recurrence and cancer-specific mortality of prostate cancer patients. Approximately 12% of prostate cancer patients present with cN1 disease at the time of diagnosis. Furthermore, with the advent of more sensitive advance diagnostic imaging techniques, such as PSMA PET/CT, the likelihood that pelvic nodes will be found earlier and more frequently.
Unfortunately, The optimal treatment for patients with cN1 still remains unclear. Androgen deprivation therapy (ADT) is the cornerstone of prostate cancer with pelvic lymph node metastasis. Some retrospective and database studies have shown that addition of local radiotherapy (RT) to ADT improve the treatment outcome. The 2022 NCCN guideline recommend RT combined with 2 to 3 years ADT in patients with initially diagnosed cN1 prostate cancer who have a life expectancy greater than 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carbon ion followed by Proton radiotherapy | Experimental | Radiation: proton plus carbon ion radiationAll patients received whole pelvis and prostate region radiotherapy. The dose to metastatic LN was escalated using simultaneous integrated boost (SIB) technique. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically proven initial diagnosis of adenocarcinoma of the prostate;
- Clinical stage T1-4 N0 M0;
- Prostatic assessment by multiparametric (mp) MRI;
- Pelvic lymph node was assessed by PSMA PET/CT and mpMRI;
- No distant metastasis was proven by PSMA PET/CT;
Key exclusion criteria (4 listed)
- No pathologically confirmed adenocarcinoma of the prostate;
- 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 |
|---|---|---|
| proton plus carbon ion radiationAll patients received whole pelvis and prostate region proton irradiation of 46 GyE in 23 fractionsfollowed by localized carbon ion irradiation of 32GyE in 8 fractions to the prostate region. The dose to metastatic LN was escalated using simultaneous integrated boost (SIB) technique. The dose was 60-62.1GyE in 23 fractions as much as dose constraints. All patients will be recommened receive 2-3 years endocrine therapy. | Radiation | Carbon ion followed by Proton radiotherapy |
Primary outcome
Biochemical relapse free survival
Time frame: From the start of systemic therapy, a median of 3 years
The prostate specific antigen less than nadir plus 2ng/ml (Phoenix definition)
5 secondary outcomes
Progression free survival
Time frame: From the start of systemic therapy, a median of 3 years
Overall survival
Time frame: From the start of systemic therapy, a median of 3 years
Metastasis free survival
Time frame: From the start of systemic therapy, a median of 3 years
Acute toxicities
Time frame: Within 3 months of the start of particle therapy
Late toxicities
Time frame: 3 months after the completion of particle therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
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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.
Qing Zhang, M.D. study director
Shanghai Proton and Heavy Ion Center
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 plus carbon ion radiation in people with 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 13 inclusion and 4 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 4 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?
Contact Ping Li, M.D. (+86-021-38296666, ping.li@sphic.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical relapse free survival (time frame: From the start of systemic therapy, a median of 3 years). 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 4 Nov 2021.