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

Phase 2

• Conditions: Metastatic Prostate Carcinoma
• Interventions: Radiation: CIRT with systemic therapy arm

• Registration Number: NCT02935023
• Lead Sponsor: Shanghai Proton and Heavy Ion Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Status Verified: 2016-10
• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-13
• Last Update Submitted: 2016-10-13
• Study First Posted: 2016-10-17
• Last Update Posted: 2016-10-17
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CIRT with systemic therapy arm	CIRT with systemic therapy arm	Carbon ion radiotherapy combined with systemic therapy

Primary Outcome Measures

Name	Time	Method
Time to PSA relapse	From the start of systemic therapy, a median of 2 years

Secondary Outcome Measures

Name	Time	Method
progression free 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
Overall survival	From the start of systemic therapy, a median of 2 years

Trial Locations

Locations (1)

Shanghai Proton and Heavy Ion Center; 🇨🇳 Shanghai, Shanghai, China