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

NCT03988686 | Unknown

• 1 other identifier: B2019-065
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer Metastatic

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of life in patients post-randomization

  three month post randomization

Study Arms (2)

Intervention Group

EXPERIMENTAL

Radical prostatectomy plus standard care

Procedure: Radical prostatectomy plus standard care; Drug: Standard of care for metastatic prostate cancer

Comparator Group

ACTIVE COMPARATOR

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

Drug: Standard of care for metastatic prostate cancer

Interventions

Radical prostatectomy plus standard care PROCEDURE

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

Intervention Group

Standard of care for metastatic prostate cancer DRUG

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

Comparator Group; Intervention Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead
• University College, London: collaborator

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jian-Ming Guo, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian-Ming Guo, MD, PhD

CONTACT

+86 13681971306; guo.jianming@zs-hospital.sh.cn

Lei Xu, MD, PhD

CONTACT

+86 18616139981; xu.lei1@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 8, 2019
• First Posted: June 17, 2019
• Study Start: April 1, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2022
• Last Updated: June 17, 2019

Record last verified: 2019-06

Locations

CN (1)