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

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

Study Overview

• Status: Recruiting
• Conditions: Localized Prostate Cancer
• Intervention / Treatment: Radiation: carbon ion irradation; Radiation: Carbon Ion Irradiation With SIB

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 Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Proton and Heavy Ion Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: carbon ion irradation group; All patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle	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
ACTIVE_COMPARATOR: Carbon Ion Irradiation With SIB group; 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	Radiation: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	The time from diagnosis to death from any cause	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	From the complation of CIRT,a median of 5 years
Late toxicities	Treatment related late toxicity assessed by Radiation Therapy Oncology Group (RTOG) scale	3 months after the completion of CIRT
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Shanghai Proton and Heavy Ion Center

Publications and helpful links

General Publications

• Hu W, Li P, Hong Z, Guo X, Pei Y, Zhang Z, Zhang Q. Functional imaging-guided carbon ion irradiation with simultaneous integrated boost for localized prostate cancer: study protocol for a phase II randomized controlled clinical trial. Trials. 2022 Nov 8;23(1):934. doi: 10.1186/s13063-022-06798-5.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2020
• Primary Completion (ANTICIPATED): July 1, 2025
• Study Completion (ANTICIPATED): July 1, 2028

Study Registration Dates

• First Submitted: March 14, 2021
• First Submitted That Met QC Criteria: August 14, 2021
• First Posted (ACTUAL): August 18, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 12, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: mpMRI; PSMA PET/CT; Simultaneous Integrated Boost; carbon ion irradiation
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: SPHIC-TR-PCa2020-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes