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

Zhongshan Hospital, Fudan University

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

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer Metastatic
• Intervention / Treatment: Procedure: Radical prostatectomy plus standard care; Drug: Standard of care for 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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jian-Ming Guo, MD, PhD; Phone Number: +86 13681971306; Email: guo.jianming@zs-hospital.sh.cn
• Study Contact Backup: Name: Lei Xu, MD, PhD; Phone Number: +86 18616139981; Email: xu.lei1@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Jian-Ming Guo, MD, PhD; Phone Number: +86 13681971306; Email: guo.jianming@zs-hospital.sh.cn
      • Contact: Lei Xu, MD, PhD; Phone Number: +86 18616139981; Email: xu.lei1@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Radical prostatectomy plus standard care	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
Active Comparator: Comparator Group; Standard care, currently ADT +/- other systemic therapies.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fudan University
• Collaborators: University College, London
• Investigators: Principal Investigator: Jian-Ming Guo, MD, PhD, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): March 31, 2021
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: June 8, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): June 17, 2019
• Last Update Submitted That Met QC Criteria: June 13, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: quality of life; prostate cancer; radical prostatectomy; progression-free survival; oligometastasis
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: B2019-065

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No