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

Shanghai Proton and Heavy Ion Center

Status and phase: Unknown; Phase 2

Conditions: Metastatic Prostate Carcinoma

Treatments: Radiation: CIRT with systemic therapy arm

Study type: Interventional

Funder types: Other

Identifiers

NCT02935023

SPHIC-TR-PCa2016-01

Details and patient eligibility

About

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

Enrollment: 47 estimated patients

Sex: Male

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

CIRT with systemic therapy arm

Experimental group

Description:

Carbon ion radiotherapy combined with systemic therapy

Treatment:

Radiation: CIRT with systemic therapy arm