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

Fudan University

Status: Unknown

Conditions: Prostate Cancer Metastatic

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03988686

B2019-065

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Radical prostatectomy plus standard care

Treatment:

Procedure: Radical prostatectomy plus standard care

Drug: Standard of care for metastatic prostate cancer

Comparator Group

Active Comparator group

Description:

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

Treatment:

Drug: Standard of care for metastatic prostate cancer