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NCT Number: NCT05010343

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

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.

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Key information

Conditions

Localized Prostate Cancer

Age range

45 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carbon ion irradation

Radiation

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 SIB

Radiation

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

Primary outcomes

  1. Acute toxicities

    Time frame: 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 outcomes

  1. Late toxicities

    Time frame: 3 months after the completion of CIRT

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

  2. Biochemical failure free survival

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

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

  3. Overall survival

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

    The time from diagnosis to death from any cause

  4. Progression free survival

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

    The time from complation of CIRT to tumor progression or death

Other outcomes

  1. The quality of life-International Prostate Symptom Score (IPSS)

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

    IPSS would be used to assess the severity of lower urinary tract symptoms, based on the answers to seven questions regarding urinary symptoms (incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia).

    Total IPSS score: 1-7: Mild; 8-19: Moderate; 20-35: Severe

  2. The quality of life-Expanded Prostate Cancer Index Composite (EPIC)

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

    EPIC would be used to evaluate the urinary, bowel, and sexual symptoms. The EPIC is a patient reported outcomes instrument designed to evaluate bowel, urinary, sexual and hormonal domains both during and after irradiation of the pelvis.For each domain, responses are provided on a 5-point Likert scale, and multi-item scale scores are transformed linearly to a scale of 0 to 100, where higher scores correspond to better quality of life.

Sponsors and collaborators

Lead sponsor

Shanghai Proton and Heavy Ion Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2028
First posted
Aug 18, 2021
Registry last updated
Nov 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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