Testing Radical Prostatectomy in Chinese Men With Prostate Cancer and oligoMetastases to the Bone

Fudan University120 enrolled

Overview

This study is to examine whether radical prostatectomy can impact survival and quality-of-life in men with oligo-metastatic prostate cancer.

In this study, patients with oligo-metastatic prostate cancer will be randomized to radical prostatectomy plus standard care and standard care only. Standard care refers to androgen deprivation therapy (ADT) +/- other systemic therapies. Time to disease progression and post-treatment quality of life will be assessed and compared.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Prostate Cancer Metastatic

Interventions

Radical prostatectomy plus standard carePROCEDURE

To add radical prostatectomy on the basis of current standard of care for those with oligometastatic prostate cancer

Standard of care for metastatic prostate cancerDRUG

androgen deprivation therapy with or without other systemic therapies based on current guidelines for metastatic prostate cancer

Eligibility

Sex: MALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants is willing and able to give informed consent for participation in the study * Male aged 19-75 years. * Diagnosed with oligo-metastatic prostate cancer (1-3 skeletal lesions on bone specific imaging, no visceral metastases). * Locally resectable tumor (clinical/radiological stage T1-T3). * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Suitable for radical prostatectomy within 12 months of starting standard care. Exclusion Criteria: * Contraindications to radical prostatectomy. * Visceral metastases. * Prior radiotherapy to the abdomen/pelvis or to skeletal metastases. * Any systemic therapy of prostate cancer (including standard care) for 12 or more months prior to enrollment. * Current involvement in other interventional research.

Locations (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

the time to castrate resistance

The time to treatment failure defined as castrate resistance will be recorded via routine patient follow-up interviews.

Time frame: 36 months after randomization

Secondary Outcomes

Quality of life in patients post-randomization

EuroQOL 5 dimensions 5 levels (EQ-5D-5L) questionnaire will be used to assess quality of life in patients after randomization with different treatments. This is designed to measure health-related quality of life. It consists of a questionnaire and a visual analogue scale. The subjects in 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression are asked to grade their own current level of function in each dimension into one of five levels of disability (i.e. I have no problems waling about, slight problems, moderate problems, severe problems, or unable to walk). This tool also has an overall health scale where the rater selects a number between 1-100 to describe the condition of their health, 100 being the best imaginable.

Time frame: three month post randomization

Central Contacts

Jian-Ming Guo, MD, PhD

CONTACT

+86 13681971306 guo.jianming@zs-hospital.sh.cn

Lei Xu, MD, PhD

CONTACT

+86 18616139981 xu.lei1@zs-hospital.sh.cn

Data from ClinicalTrials.gov

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