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

NCT02935023 | Unknown Phase 2 DMC

• 1 other identifier: SPHIC-TR-PCa2016-01
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• Time to PSA relapse

  From the start of systemic therapy, a median of 2 years

Secondary Outcomes (3)

• progression free survival

  From the start of systemic therapy, a median of 2 years

• Overall survival

  From the start of systemic therapy, a median of 2 years

• Quality of life

  From the start of carbon ion radiotherapy, a median of 2 years

Study Arms (1)

CIRT with systemic therapy arm

EXPERIMENTAL

Carbon ion radiotherapy combined with systemic therapy

Radiation: CIRT with systemic therapy arm

Interventions

CIRT with systemic therapy arm 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

CIRT with systemic therapy arm

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• No pathologically confirmed adenocarcinoma of the prostate
• visceral metastasis
• Previous pelvic radiotherapy or prostatectomy
• Severe systemic disorders

Sponsors & Collaborators

• Shanghai Proton and Heavy Ion Center: lead

Study Sites (1)

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, 201321, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Heavy Ion Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Shen Fu, PhD.MD.

  Shanghai Proton and Heavy Ion Center

  STUDY DIRECTOR

Central Study Contacts

Ping Li, MD.

CONTACT

+86 02138296666; ping.li@sphic.org.cn

Qing Zhang, MD.

CONTACT

+86 02138296666; qing.zhang@sphic.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director,department of radiation oncology

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: October 17, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: October 17, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)