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

Not Applicable

• Conditions: Prostate Cancer Metastatic
• Interventions: Procedure: Radical prostatectomy plus standard care; Drug: Standard of care for metastatic prostate cancer

• Registration Number: NCT03988686
• Lead Sponsor: Fudan University

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2019-04-01
• Status Verified: 2019-06
• Study First Submitted: 2019-06-08
• Study First Submitted QC: 2019-06-13
• Last Update Submitted: 2019-06-13
• Study First Posted: 2019-06-17
• Last Update Posted: 2019-06-17
• Primary Completion: 2021-03-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Radical prostatectomy plus standard care	Radical prostatectomy plus standard care
Intervention Group	Standard of care for metastatic prostate cancer	Radical prostatectomy plus standard care
Comparator Group	Standard of care for metastatic prostate cancer	Standard care, currently ADT +/- other systemic therapies.

Primary Outcome Measures

Name	Time	Method
the time to castrate resistance	36 months after randomization	The time to treatment failure defined as castrate resistance will be recorded via routine patient follow-up interviews.

Secondary Outcome Measures

Name	Time	Method
Quality of life in patients post-randomization	three month 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.

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China