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

Last updated: June 13, 2019
Sponsor: Fudan University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer, Early, Recurrent

Prostate Disorders

Prostate Cancer

Treatment

N/A

Clinical Study ID

NCT03988686
B2019-065
  • Ages 18-75
  • Male

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants is willing and able to give informed consent for participation in thestudy

  • Male aged 19-75 years.

  • Diagnosed with oligo-metastatic prostate cancer (1-3 skeletal lesions on bone specificimaging, 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

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 moremonths prior to enrollment.

  • Current involvement in other interventional research.

Study Design

Total Participants: 120
Study Start date:
April 01, 2019
Estimated Completion Date:
March 31, 2022

Study 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.

Connect with a study center

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

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