Prostate CancerPhase 1/2NCT02816840
PET-CT/MRI in the Radiotherapy for Prostate Cancer
A Phase 1/2 study testing PET-CT and PET-MRI in people with Prostate Cancer, run by Xuzhou Medical University.
Trial summary
The trial is to explore new and effective techniques in the treatment of prostate cancer and evaluate the role of PET-CT / MRI played in radiotherapy. Intensity modulated radiation therapy(IMRT) is adopted with all patients and the efficacy assessment for the prostate cancer will be examined with PET / CT or CT in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PET-CT and PET-MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Aug 2019
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pathologically confirmed prostate cancer
- Staged with Ⅲ-Ⅳ prostate cancer
- Aged from 18 to 65 years old
- Quality of life score (Karnofsky performance score) > 70
- No distant metastasis
- No serious internal diseases may affect the treatment plan
- No previous history of prostate radiation therapy
- Patients must be able to understand and be willing to sign a written informed consent document.
Who cannot join
- Distant metastasis
- Accompanied by other malignancies
- Previous history of prostate radiation therapy
- Pregnant or lactating women
- History of allergic reaction to iodinated, non-iodinated, and/or gadolinium contrast agents
- Liver and kidney dysfunction
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- Pacemaker or other metallic devices that would prevent MRI imaging from being performed
- Patients quit during the treatment or violate of the study protocol caused by other factors
- Any reason that, in the option of the investigator, contraindicates that the patient participates in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pilot Study of the Incorporation of PET-CT/MRI in the Radiotherapy for Prostate Cancer
The trial is to explore new and effective techniques in the treatment of prostate cancer and evaluate the role of PET-CT / MRI played in radiotherapy. Intensity modulated radiation therapy(IMRT) is adopted with all patients and the efficacy assessment for the prostate cancer will be examined with PET / CT or CT in three months after radiotherapy.
Read the detailed description
All participants judged to have prostate cancer with stage Ⅲ-Ⅳand considered able to conduct radiotherapy. 180 patients will be enrolled in the trial and randomly divided into three groups. Three arms are respectively treated with CT、18F-FDG PET/CT、18F-FDG PET/MRI. The images were passed in three-dimensional treatment planning system, using software manually fusion and reconstruction of PET and CT. All patients adopt IMRT for the radiotherapy with 70Gy-80Gy. Three months after radiotherapy, solid tumer size for the prostate cancer will be assesed with PET / CT or CT. Early radiation reactions are evaluated by the United States RTOG (RTOG) acute response evaluation criteria, and late radiation reaction are evaluated with RTOG and the European Radiation Therapy Oncology Organization (EORTC). Before and after radiotherapy treatment,the tumor-associated marker of PSA will be monitored and the patients are regularly followed-up in the next three years.
- Conditions
- Prostate Cancer
- Being tested
- PET-CT, PET-MRI
- Keywords
- prostate cancer, radiotherapy, PET-CT/MRI
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-CTRadiation
Patients in this arm take radiotherapy positioning with PET-CT.
PET-MRIRadiation
Patients in this arm take radiotherapy positioning with PET-MRI.
| Study group | Role | What they receive |
|---|---|---|
| PET-CT | Experimental | Patients in this arm take radiotherapy positioning with PET-CT. Receives: Radiation: PET-CT |
| PET-MRI | Experimental | Patients in this arm take radiotherapy positioning with PET-MRI. Receives: Radiation: PET-MRI |
| Computed Tomography | No intervention | Patients in this arm take radiotherapy positioning with CT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solid tumor size
Three months after radiotherapy, the efficacy assessment for the prostate cancer will be examined with PET/CT or CT.
Measured: Three months
Secondary outcomes (1)
Relapse-free survival
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Longzhen Zhang, Xuzhou Medical University
- Investigators
- Longzhen Zhang, MD, Principal investigator, Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816840
- Sponsor's protocol ID
- XYFY2016-KL015-01
- Status last verified
- Jun 2016
- First submitted
- 23 Jun 2016
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Incorporation of PET-CT/MRI in the Radiotherapy for Prostate Cancer
- ClinicalTrials.gov ID
- NCT02816840
- Acronym / sponsor ID
- XYFY2016-KL015-01
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, radiotherapy, PET-CT/MRI
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 29 Jun 2016 (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.
The trial is to explore new and effective techniques in the treatment of prostate cancer and evaluate the role of PET-CT / MRI played in radiotherapy. Intensity modulated radiation therapy(IMRT) is adopted with all patients and the efficacy assessment for the prostate cancer will be examined with PET / CT or CT in three months after radiotherapy.
Detailed description
All participants judged to have prostate cancer with stage Ⅲ-Ⅳand considered able to conduct radiotherapy. 180 patients will be enrolled in the trial and randomly divided into three groups. Three arms are respectively treated with CT、18F-FDG PET/CT、18F-FDG PET/MRI. The images were passed in three-dimensional treatment planning system, using software manually fusion and reconstruction of PET and CT. All patients adopt IMRT for the radiotherapy with 70Gy-80Gy. Three months after radiotherapy, solid tumer size for the prostate cancer will be assesed with PET / CT or CT. Early radiation reactions are evaluated by the United States RTOG (RTOG) acute response evaluation criteria, and late radiation reaction are evaluated with RTOG and the European Radiation Therapy Oncology Organization (EORTC). Before and after radiotherapy treatment,the tumor-associated marker of PSA will be monitored and the patients are regularly followed-up in the next three years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PET-CT | Experimental | Radiation: PET-CTPatients in this arm take radiotherapy positioning with PET-CT. |
| PET-MRI | Experimental | Radiation: PET-MRIPatients in this arm take radiotherapy positioning with PET-MRI. |
| Computed Tomography | No intervention | –Patients in this arm take radiotherapy positioning with CT. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with pathologically confirmed prostate cancer
- Staged with Ⅲ-Ⅳ prostate cancer
- Aged from 18 to 65 years old
- Quality of life score (Karnofsky performance score) > 70
- No distant metastasis
Key exclusion criteria (9 listed)
- Distant metastasis
- Accompanied by other malignancies
- Previous history of prostate radiation therapy
- Pregnant or lactating women
- History of allergic reaction to iodinated, non-iodinated, and/or gadolinium contrast agents
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 |
|---|---|---|
| PET-CTPatients in this arm take radiotherapy positioning with PET-CT. | Radiation | PET-CT |
| PET-MRIPatients in this arm take radiotherapy positioning with PET-MRI. | Radiation | PET-MRI |
Primary outcome
Solid tumor size
Time frame: Three months
Three months after radiotherapy, the efficacy assessment for the prostate cancer will be examined with PET/CT or CT.
1 secondary outcome
Relapse-free survival
Time frame: Three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
- 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.
Longzhen Zhang, MD principal investigator
Xuzhou Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PET-CT and PET-MRI in people with Prostate Cancer, run by Xuzhou Medical University.
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 8 inclusion and 9 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 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Longzhen Zhang, MD (15895236960, jsxzzlz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Solid tumor size (time frame: Three months). 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 29 Jun 2016.