NCT05010343RecruitingPhase 2
Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer
Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer: a Phase II Randomized Controlled Clinical Trial
Source: ClinicalTrials.gov · Last updated 15 Nov 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a phase II randomized controlled clinical trial to assess the toxicities and clinical efficacy of prostate specific membrane antigen (PSMA) positron emission tomography / computed tomography (PET/CT) and multi- parameter Magnetic Resonance Imaging (MRI) guided simultaneous integrated boost for prostate cancer.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 14 Mar 2021
- Start date
- Oct 2020
- Primary completion date
- Jul 2025
- Lead sponsor
- Shanghai Proton and Heavy Ion Center
- Diseases
- Prostate cancer
- NCT number
- NCT05010343
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 140
- From Oct 2020 to the primary completion date, Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous pelvic radiotherapy
- Previous prostatectomy
Other
- No pathologically confirmed adenocarcinoma of the prostate
- Pelvic lymph node metastasis (N1)
- Distant metastasis (M1)
Who the study is looking for
- Pathologically confirmed adenocarcinoma of prostate
- Stage cT1-3N0M0 localized prostate cancer
- performed PSMA PET/CT and mpMRI before treatment
- No lymph nodes or distant metastasis
- Age ≥ 45 and \< 85 years of age
- Karnofsky Performance Score ≥70
- 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
- Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial
Age in the registry: 45 years to 85 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Proton and Heavy Ion Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.