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

Shanghai Proton and Heavy Ion Center

Status and phase: Enrolling; Phase 2

Conditions: Localized Prostate Cancer

Treatments: Radiation: carbon ion irradation; Radiation: Carbon Ion Irradiation With SIB

Study type: Interventional

Funder types: Other

Identifiers

NCT05010343

SPHIC-TR-PCa2020-01

Details and patient eligibility

About

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.

Full description

Local recurrences of prostate cancer following radiotherapy often originate from the primary tumor site. Therefore,focal boost to the primary gross tumor has been proposed to increase biochemical disease-free survival (bDFS) without increasing toxicity.

The higher relative biological effectiveness (RBE) and greater cytocidal effect on the intrinsic radiation resistant cancer cells offer carbon ion radiotherapy (CIRT) advantages over conventional radiotherapy. In this study, carbon ion were used to treat localized prostate cancer and simultaneous integrated boost to the gross tumor in the prostate specific membrane antigen (PSMA) PET/CT and multi- parameter MRI.

Enrollment: 140 estimated patients

Sex: Male

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

carbon ion irradation group

Active Comparator group

Description:

All patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle

Treatment:

Radiation: carbon ion irradation

Carbon Ion Irradiation With SIB group

Active Comparator group

Description:

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

Treatment:

Radiation: Carbon Ion Irradiation With SIB