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

October 13, 2016 updated by: Shen Fu, Shanghai Proton and Heavy Ion Center
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

47

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201321
        • Recruiting
        • Shanghai Proton and Heavy Ion Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CIRT with systemic therapy arm
Carbon ion radiotherapy combined with systemic therapy
Radiation: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to PSA relapse
Time Frame: From the start of systemic therapy, a median of 2 years
From the start of systemic therapy, a median of 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
progression free survival
Time Frame: From the start of systemic therapy, a median of 2 years
From the start of systemic therapy, a median of 2 years
Overall survival
Time Frame: From the start of systemic therapy, a median of 2 years
From the start of systemic therapy, a median of 2 years
Quality of life
Time Frame: From the start of carbon ion radiotherapy, a median of 2 years
From the start of carbon ion radiotherapy, a median of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Proton and Heavy Ion Center

Investigators

  • Study Director: Shen Fu, PhD.MD., Shanghai Proton and Heavy Ion Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

October 11, 2016

First Submitted That Met QC Criteria

October 13, 2016

First Posted (Estimate)

October 17, 2016

Study Record Updates

Last Update Posted (Estimate)

October 17, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPHIC-TR-PCa2016-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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