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Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer

RECRUITINGPhase 2Sponsored by Shanghai Proton and Heavy Ion Center
Actively Recruiting
PhasePhase 2
SponsorShanghai Proton and Heavy Ion Center
Started2020-10-15
Est. completion2025-07-01
Eligibility
Age45 Years – 85 Years
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05010343

Summary

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.

Eligibility

Age: 45 Years – 85 YearsSex: MALEHealthy volunteers accepted
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

Conditions2

CancerLocalized Prostate Cancer

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