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

Prostate Cancer Metastatic Clinical Trial

Official title:

Zhongshan Hospital, Fudan University

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03988686
• Other study ID #: B2019-065
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: June 2019
• Source: Fudan University
• Contact: Jian-Ming Guo, MD, PhD
• Phone: +86 13681971306
• Email: guo.jianming[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer Metastatic
• Prostatic Neoplasms

Intervention

Procedure:
• Radical prostatectomy plus standard care
To add radical prostatectomy on the basis of current standard of care for those with oligometastatic prostate cancer

Drug:
• Standard of care for metastatic prostate cancer
androgen deprivation therapy with or without other systemic therapies based on current guidelines for metastatic prostate cancer

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Fudan University	University College, London

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the time to castrate resistance	The time to treatment failure defined as castrate resistance will be recorded via routine patient follow-up interviews.	36 months after randomization
Secondary	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.	three month post randomization