Carbon Ion Radiotherapy in Treating Patients Undergoing Systemic Therapy for Oligo-metastatic Prostate Cancer

NCT ID: NCT02935023

Last Updated: 2016-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-09-30

Brief Summary

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The goal of this clinical study is to determine impact of carbon ion radiotherapy (CIRT) treatment in combination with systemic therapy for oligo-metastatic prostate cancer. The primary objective: to determine disease biochemical progression-free survival in man with oligo-metastatic (M1a/b) prostate cancer undergoing systemic therapy with definitive radiotherapy of the primary tumor. The secondary objective: to determine local control, overall survival and quality of life in men with oligo-metastatic prostate cancer undergoing carbon ion radiotherapy

Detailed Description

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Conditions

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Metastatic Prostate Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CIRT with systemic therapy arm

Carbon ion radiotherapy combined with systemic therapy

Group Type EXPERIMENTAL

CIRT with systemic therapy arm

Intervention Type RADIATION

carbon ion radiotherapy to the prostate(59.2GyE/16Fx to prostate and seminal vesicle) Systemic therapy:Hormonal therapy (LHRH agonist and/or antiandrogens) or chemotherapy

Interventions

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CIRT with systemic therapy arm

carbon ion radiotherapy to the prostate(59.2GyE/16Fx to prostate and seminal vesicle) Systemic therapy:Hormonal therapy (LHRH agonist and/or antiandrogens) or chemotherapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

1. Pathologically confirmed adenocarcinoma of the prostate
2. Age ≥ 20 and \< 80 years of age
3. ECOG PS 0 or 1
4. Life-expectancy ≥1 year
5. Stage T1-4,N0-1,M1a/b disease on imaging, with a combined maximum of 3 synchronous lesions.
6. Ability to understand and willingness to sign informed consent

Exclusion Criteria

1. No pathologically confirmed adenocarcinoma of the prostate
2. visceral metastasis
3. Previous pelvic radiotherapy or prostatectomy
4. Severe systemic disorders
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Proton and Heavy Ion Center

OTHER

Sponsor Role lead

Responsible Party

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Shen Fu

Director,department of radiation oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shen Fu, PhD.MD.

Role: STUDY_DIRECTOR

Shanghai Proton and Heavy Ion Center

Locations

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Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ping Li, MD.

Role: CONTACT

+86 02138296666

Qing Zhang, MD.

Role: CONTACT

+86 02138296666

Facility Contacts

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Renli Ning

Role: primary

+86 02138296666

Other Identifiers

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SPHIC-TR-PCa2016-01

Identifier Type: -

Identifier Source: org_study_id

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