Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer
Recruiting
Phase 2Interventional Study
Localized Prostate Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
45 – 85
Sex
Male
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
140 (estimated)
Sponsor
Shanghai Proton and Heavy Ion Center · Other
Who this trial is looking for
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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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* 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 ra…
Inclusion Criteria:
* 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
Exclusion Criteria:
* No pathologically confirmed adenocarcinoma of the prostate
* Pelvic lymph node metastasis (N1)
* Distant metastasis (M1)
* Previous pelvic radiotherapy
* Previous prostatectomy
Contacts
No contact information available.
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