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

Primary Purpose

Prostate Cancer Metastatic

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Radical prostatectomy plus standard care

Standard of care for metastatic prostate cancer

About this trial

This is an interventional treatment trial for Prostate Cancer Metastatic focused on measuring oligometastasis, prostate cancer, radical prostatectomy, progression-free survival, quality of life

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Zhongshan Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Comparator Group

Arm Description

Radical prostatectomy plus standard care

Standard care, currently ADT +/- other systemic therapies.

Outcomes

Primary Outcome Measures

the time to castrate resistance

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03988686

First Posted

June 8, 2019

Last Updated

June 13, 2019

Sponsor

Fudan University

Collaborators

University College, London

1. Study Identification

Unique Protocol Identification Number

NCT03988686

Brief Title

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

Official Title

Zhongshan Hospital, Fudan University

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2019 (Actual)

Primary Completion Date

March 31, 2021 (Anticipated)

Study Completion Date

March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

Collaborators

University College, London

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer Metastatic

Keywords

oligometastasis, prostate cancer, radical prostatectomy, progression-free survival, quality of life

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

Radical prostatectomy plus standard care

Arm Title

Comparator Group

Arm Type

Active Comparator

Arm Description

Standard care, currently ADT +/- other systemic therapies.

Intervention Type

Procedure

Intervention Name(s)

Radical prostatectomy plus standard care

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Standard of care for metastatic prostate cancer

Intervention Description

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

Primary Outcome Measure Information:

Title

the time to castrate resistance

Description

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 Outcome Measure Information:

Title

Quality of life in patients post-randomization

Description

Time Frame

three month post randomization

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jian-Ming Guo, MD, PhD

Phone

+86 13681971306

guo.jianming@zs-hospital.sh.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Lei Xu, MD, PhD

Phone

+86 18616139981

xu.lei1@zs-hospital.sh.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jian-Ming Guo, MD, PhD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongshan Hospital, Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jian-Ming Guo, MD, PhD

Phone

+86 13681971306

guo.jianming@zs-hospital.sh.cn

First Name & Middle Initial & Last Name & Degree

Lei Xu, MD, PhD

Phone

+86 18616139981

xu.lei1@zs-hospital.sh.cn

12. IPD Sharing Statement

Learn more about this trial

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

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