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Carbon Ion Radiotherapy for the Treatment of Localized Prostate Cancer

Primary Purpose

Prostate Carcinoma

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

carbon-ion radiotherapy

About this trial

This is an interventional treatment trial for Prostate Carcinoma focused on measuring prostate carcinoma, carbon-ion radiotherapy, efficacy, toxicity

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Pathologically confirmed adenocarcinoma of the prostate
No lymph node and distant metastasis
Age ≥ 20 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)except for skin non-melanoma cancer
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)
Urinary obstructive symptoms (IPSS > 20)
Previous pelvic radiotherapy
Previous prostatectomy
Severe systemic disorders
Concomitant disorders including: chronic urinary or intestinal inflammatory conditions (for example, ulcerous recto-colitis, Crohn disease), anti-coagulant treatment (warfarin, heparin)
Previous malignancy except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like non muscle invasive bladder cancer
Non conformity of the radiotherapy dose distribution when compared to the dose constraints
Psychiatric disorders or any other condition that can make unreliable the informed consent

Sites / Locations

Shanghai Proton and Heavy Ion CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

carbon-ion radiotherapy

Arm Description

Five dose levels [59.2 GyE(Gray equivalent)/16Fx, 60.8 GyE/16Fx, 62.4 GyE/16Fx, 64.0 GyE/16Fx and 65.6 GyE/16Fx] are planned within the Phase I part. After the recommended dose (RD), i.e., MTD, is determined or if the treatments to 65.6 GyE/16Fx are safely delivered, the recommended dose (or 65.6 GyE/16Fx) will be the prescribed dose in the Phase II part of the study.

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures

Overall survival of all patients

biochemical failure-free survival，bFFS

Progression-free survival of all patients

Full Information

NCT ID

NCT02739659

First Posted

April 7, 2016

Last Updated

November 12, 2021

Sponsor

Shanghai Proton and Heavy Ion Center

1. Study Identification

Unique Protocol Identification Number

NCT02739659

Brief Title

Carbon Ion Radiotherapy for the Treatment of Localized Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

January 2016 (Actual)

Primary Completion Date

December 1, 2022 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Proton and Heavy Ion Center

4. Oversight

5. Study Description

Brief Summary

The aim of this research project is to assess the feasibility and safety of carbon-ion radiotherapy (CIRT) for the treatment of in Chinese localized prostate cancer

Detailed Description

The purpose of this study is to determine the maximal tolerated dose (MTD) of CIRT in the treatment of localized prostate cancer and to evaluate the efficacy of such treatment at the MTD. Participants will be treated with CIRT with escalating dose regimens to evaluate the maximal tolerated dose (MTD) in terms of acute and subacute toxicity observed during and within 6 months after the completion of CIRT. Once the MTD for localized prostate cancer is determined, the MTD will be used as the recommended dose to patients fulfilling the inclusion criteria in the Phase II part of the trial.

6. Conditions and Keywords

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

Prostate Carcinoma

Keywords

prostate carcinoma, carbon-ion radiotherapy, efficacy, toxicity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

73 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

carbon-ion radiotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

carbon-ion radiotherapy

Primary Outcome Measure Information:

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time Frame

From the date of CIRT to 6 months after the completion of CIRT, up to 6 months

Secondary Outcome Measure Information:

Title

Overall survival of all patients

Time Frame

From the diagnosis of localized prostate, a median of 2 years

Title

biochemical failure-free survival，bFFS

Time Frame

From the completion of CIRT, a median of 2 years

Title

Progression-free survival of all patients

Time Frame

From the completion of CIRT, a median of 2 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pathologically confirmed adenocarcinoma of the prostate No lymph node and distant metastasis Age ≥ 20 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)except for skin non-melanoma cancer 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) Urinary obstructive symptoms (IPSS > 20) Previous pelvic radiotherapy Previous prostatectomy Severe systemic disorders Concomitant disorders including: chronic urinary or intestinal inflammatory conditions (for example, ulcerous recto-colitis, Crohn disease), anti-coagulant treatment (warfarin, heparin) Previous malignancy except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like non muscle invasive bladder cancer Non conformity of the radiotherapy dose distribution when compared to the dose constraints Psychiatric disorders or any other condition that can make unreliable the informed consent

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ping Li, Dr.

ping.li@sphic.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qing Zhang, Dr.

Organizational Affiliation

Shanghai Proton and Heavy Ion Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai Proton and Heavy Ion Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

201321

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ping Li, Dr.

ping.li@sphic.org.cn

First Name & Middle Initial & Last Name & Degree

Qing Zhang, Dr.

qing.zhang@sphic.org.cn

First Name & Middle Initial & Last Name & Degree

Qing Zhang, Dr.

12. IPD Sharing Statement

Citations:

PubMed Identifier

31164172

Citation

Zhang Y, Li P, Yu Q, Wu S, Chen X, Zhang Q, Fu S. Preliminary exploration of clinical factors affecting acute toxicity and quality of life after carbon ion therapy for prostate cancer. Radiat Oncol. 2019 Jun 4;14(1):94. doi: 10.1186/s13014-019-1303-3.

Results Reference

derived

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Carbon Ion Radiotherapy for the Treatment of Localized Prostate Cancer

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