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

Primary Purpose

Localized Prostate Cancer

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

carbon ion irradation

Carbon Ion Irradiation With SIB

About this trial

This is an interventional treatment trial for Localized Prostate Cancer focused on measuring carbon ion irradiation, Simultaneous Integrated Boost, PSMA PET/CT, mpMRI

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Shanghai Proton and Heavy Ion CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

carbon ion irradation group

Carbon Ion Irradiation With SIB group

Arm Description

All patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle

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

Outcomes

Primary Outcome Measures

Acute toxicities

Treatment related acute toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

Secondary Outcome Measures

Late toxicities

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

Biochemical failure free survival

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

Overall survival

The time from diagnosis to death from any cause

Progression free survival

The time from complation of CIRT to tumor progression or death

Full Information

NCT ID

NCT05010343

First Posted

March 14, 2021

Last Updated

November 12, 2021

Sponsor

Shanghai Proton and Heavy Ion Center

1. Study Identification

Unique Protocol Identification Number

NCT05010343

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

October 15, 2020 (Actual)

Primary Completion Date

July 1, 2025 (Anticipated)

Study Completion Date

July 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Proton and Heavy Ion Center

4. Oversight

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

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Localized Prostate Cancer

Keywords

carbon ion irradiation, Simultaneous Integrated Boost, PSMA PET/CT, mpMRI

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

carbon ion irradation group

Arm Type

Active Comparator

Arm Description

All patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle

Arm Title

Carbon Ion Irradiation With SIB group

Arm Type

Active Comparator

Arm Description

Intervention Type

Radiation

Intervention Name(s)

carbon ion irradation

Intervention Description

All patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle

Intervention Type

Radiation

Intervention Name(s)

Carbon Ion Irradiation With SIB

Intervention Description

Primary Outcome Measure Information:

Title

Acute toxicities

Description

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 Outcome Measure Information:

Title

Late toxicities

Description

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

Time Frame

3 months after the completion of CIRT

Title

Biochemical failure free survival

Description

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

Time Frame

From the complation of CIRT,a median of 5 years

Title

Overall survival

Description

The time from diagnosis to death from any cause

Time Frame

From the diagnosis of prostate cancer,a median of 5 years

Title

Progression free survival

Description

The time from complation of CIRT to tumor progression or death

Time Frame

From the complation of CIRT,a median of 5 years

Other Pre-specified Outcome Measures:

Title

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

Description

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

Title

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

Description

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Shanghai Proton and Heavy Ion Center

City

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ping Li

Phone

38296666

ping.li@sphic.org.cn

First Name & Middle Initial & Last Name & Degree

Qing Zhang

Phone

38296666

qing.zhang@sphic.org.cn

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36348363

Citation

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.

Results Reference

derived

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

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