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

Phase 2

Recruiting

• Conditions: Localized Prostate Cancer

• Registration Number: NCT05010343
• Lead Sponsor: Shanghai Proton and Heavy Ion Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-10-15
• Study First Submitted: 2021-03-14
• Study First Submitted QC: 2021-08-14
• Study First Posted: 2021-08-18
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-12
• Last Update Posted: 2021-11-15
• Primary Completion: 2025-07-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Acute toxicities	Within 3 months of the start of CIRT	Treatment related acute toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

Secondary Outcome Measures

Name	Time	Method
Late toxicities	3 months after the completion of CIRT	Treatment related late toxicity assessed by Radiation Therapy Oncology Group (RTOG) scale
Biochemical failure free survival	From the complation of CIRT,a median of 5 years	The prostate specific antigen less than nadir plus 2ng/ml (Phoenix definition)
Progression free survival	From the complation of CIRT,a median of 5 years	The time from complation of CIRT to tumor progression or death
Overall survival	From the diagnosis of prostate cancer,a median of 5 years	The time from diagnosis to death from any cause

Trial Locations

Locations (1)

Shanghai Proton and Heavy Ion Center; 🇨🇳 Shanghai, China