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

NCT ID: NCT03988686

Last Updated: 2019-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2022-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer Metastatic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Group

Radical prostatectomy plus standard care

Group Type EXPERIMENTAL

Radical prostatectomy plus standard care

Intervention Type PROCEDURE

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

Standard of care for metastatic prostate cancer

Intervention Type DRUG

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

Comparator Group

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

Group Type ACTIVE_COMPARATOR

Standard of care for metastatic prostate cancer

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Radical prostatectomy plus standard care

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

Intervention Type PROCEDURE

Standard of care for metastatic prostate cancer

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University College, London

OTHER

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jianming Guo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jian-Ming Guo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jian-Ming Guo, MD, PhD

Role: CONTACT

+86 13681971306

Lei Xu, MD, PhD

Role: CONTACT

+86 18616139981

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jian-Ming Guo, MD, PhD

Role: primary

+86 13681971306

Lei Xu, MD, PhD

Role: backup

+86 18616139981

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B2019-065

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.