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

ConditionLocalized Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age45-85
SponsorShanghai Proton and Heavy Ion Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

No pathologically confirmed adenocarcinoma of the prostate

Pelvic lymph node metastasis (N1)

Distant metastasis (M1)

Previous pelvic radiotherapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: carbon ion irradation groupActive comparator 1 intervention
Group B: Carbon Ion Irradiation With SIB groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

Late toxicities

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

Time frame
3 months after the completion of CIRT
2

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
3

Overall survival

The time from diagnosis to death from any cause

Time frame
From the diagnosis of prostate cancer,a median of 5 years
4

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

Other outcomes

1

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

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

Time frame
From the complation of CIRT, a median of 5 years
2

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

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.

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Proton and Heavy Ion Center

Lead sponsor

Source ClinicalTrials.gov
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