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

Phase 2RecruitingNCT05010343

Shanghai Proton and Heavy Ion Center140 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Localized Prostate Cancer

Interventions

carbon ion irradationRADIATION

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

Carbon Ion Irradiation With SIBRADIATION

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

Eligibility

Sex: MALEMin age: 45 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Shanghai Proton and Heavy Ion Center

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

Acute toxicities

Treatment related acute toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

Time frame: Within 3 months of the start of CIRT

Secondary Outcomes

Late toxicities

Treatment related late toxicity assessed by Radiation Therapy Oncology Group (RTOG) scale

Time frame: 3 months after the completion of CIRT

Biochemical failure free survival

The prostate specific antigen less than nadir plus 2ng/ml (Phoenix definition)

Time frame: From the complation of CIRT,a median of 5 years

Overall survival

The time from diagnosis to death from any cause

Time frame: From the diagnosis of prostate cancer,a median of 5 years

Progression free survival

The time from complation of CIRT to tumor progression or death

Time frame: From the complation of CIRT,a median of 5 years

Data from ClinicalTrials.gov

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