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

Sponsor

Shanghai Proton and Heavy Ion Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05010343

Collaborator

(none)

140

Enrollment

Location

Arms

92.5

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Localized Prostate Cancer	Radiation: carbon ion irradation Radiation: Carbon Ion Irradiation With SIB	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 15, 2020

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2028

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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)
Overall survival [From the diagnosis of prostate cancer,a median of 5 years]
The time from diagnosis to death from any cause
Progression free survival [From the complation of CIRT,a median of 5 years]
The time from complation of CIRT to tumor progression or death

Other Outcome Measures

The quality of life-International Prostate Symptom Score (IPSS) [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
The quality of life-Expanded Prostate Cancer Index Composite (EPIC) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 85 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Proton and Heavy Ion Center	Shanghai		China

Sponsors and Collaborators

Shanghai Proton and Heavy Ion Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ping Li, Principal Investigator, Shanghai Proton and Heavy Ion Center

ClinicalTrials.gov Identifier:

NCT05010343

Other Study ID Numbers:

SPHIC-TR-PCa2020-01

First Posted:

Aug 18, 2021

Last Update Posted:

Nov 15, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Ping Li, Principal Investigator, Shanghai Proton and Heavy Ion Center

carbon ion irradiation

Simultaneous Integrated Boost

PSMA PET/CT

mpMRI

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Nov 15, 2021