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

Localized Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05010343
• Other study ID #: SPHIC-TR-PCa2020-01
• Status: Recruiting
• Phase: Phase 2
• Start date: October 15, 2020
• Est. completion date: July 1, 2028

Study information

• Verified date: November 2021
• Source: Shanghai Proton and Heavy Ion Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: July 1, 2028
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Localized Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• carbon ion irradation
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
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

Locations

Country	Name	City	State
China	Shanghai Proton and Heavy Ion Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Proton and Heavy Ion Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	From the complation of CIRT, a median of 5 years
Other	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.	From the complation of CIRT, a median of 5 years
Primary	Acute toxicities	Treatment related acute toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03	Within 3 months of the start of CIRT
Secondary	Late toxicities	Treatment related late toxicity assessed by Radiation Therapy Oncology Group (RTOG) scale	3 months after the completion of CIRT
Secondary	Biochemical failure free survival	The prostate specific antigen less than nadir plus 2ng/ml (Phoenix definition)	From the complation of CIRT,a median of 5 years
Secondary	Overall survival	The time from diagnosis to death from any cause	From the diagnosis of prostate cancer,a median of 5 years
Secondary	Progression free survival	The time from complation of CIRT to tumor progression or death	From the complation of CIRT,a median of 5 years