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Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer: a Phase II Randomized Controlled Clinical Trial

Who is this study for? Patients with Prostate Cancer
What treatments are being studied? Carbon Ion Irradation
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Male
Minimum Age: 45
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Shanghai Proton and Heavy Ion Center
RECRUITING
Shanghai
Time Frame
Start Date: 2020-10-15
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 140
Treatments
Active_comparator: carbon ion irradation group
All patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle
Active_comparator: Carbon Ion Irradiation With SIB group
All patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle, and with simultaneous integrated boost (SIB) to the gross tumor in the PSMA PET/CT and mpMRI
Related Therapeutic Areas
Sponsors
Leads: Shanghai Proton and Heavy Ion Center

This content was sourced from clinicaltrials.gov