Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic Prostate Cancer

Last updated: May 1, 2025
Sponsor: Yale University
Overall Status: Active - Recruiting

Phase

2

Condition

Adenocarcinoma

Treatment

Laboratory Biomarker Analysis

Questionnaire Administration

Docetaxel

Clinical Study ID

NCT03456843
2000031290
081707
P30CA072720
Pro20170001506
NCI-2018-00047
  • Ages > 18
  • Male

Study Summary

This randomized phase II trial studies how well surgical removal of the prostate and antiandrogen therapy with or without docetaxel work in treating men with newly diagnosed prostate cancer that has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Antiandrogen therapy may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as docetaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Surgery, antiandrogen therapy and docetaxel may work better in treating participants with prostate cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically proven adenocarcinoma of the prostate

  • Evidence of metastasis by magnetic resonance imaging (MRI)/computed tomography (CT)scan, bone scan, or histologic confirmation

  • Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (solid organ metastasis.

  • If solitary lesion, metastasis confirmed with either biopsy or two independentimaging modalities (i.e. CT and PET [positron emission tomography], bone scan andMRI, modality at the discretion of the treating physician)

  • No previous local therapy for prostate cancer (i.e prostate radiation, cryotherapy,etc.)

  • Give informed consent

  • Prostate deemed resectable by surgeon

  • Plans to start or has already started antiandrogen therapy (ADT) no longer than 6months prior to consent

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  • Hemoglobin (HgB) >= 9 g/dL compatible for surgery

  • Platelets > 80,000/mcL compatible for surgery

  • Aspartate aminotransferase (AST) =< 2x upper limit of normal (ULN) compatible forsurgery

  • Alanine aminotransferase (ALT) =< 2x upper limit of normal (ULN) compatible forsurgery

Exclusion

Exclusion Criteria:

  • Refuses to give informed consent

  • Deemed to have unresectable disease by surgeon

  • Received ADT for more than 6 months prior to consent

  • Life expectancy of less than 6 months prior to consent

  • Active spinal cord compression

  • Deep vein thrombosis (DVT) / pulmonary embolism (PE) in the past 6 months prior toconsent

  • Previous local therapy for prostate cancer

  • Patients who have chemotherapy or radiotherapy for non-prostate cancer relatedtreatment within 3 weeks prior to consent

Study Design

Total Participants: 190
Treatment Group(s): 6
Primary Treatment: Laboratory Biomarker Analysis
Phase: 2
Study Start date:
March 20, 2018
Estimated Completion Date:
March 31, 2027

Study Description

PRIMARY OBJECTIVES:

I. To assess the clinical benefit of combining radical surgery cytoreductive radical prostatectomy (CRP) - with the best systemic therapy (BST) in men with newly diagnosed clinical metastatic prostate cancer (mPCa).

SECONDARY OBJECTIVES:

I. To determine the impact of CRP+BST on time to biochemical progression, cancer-specific survival, complication rates, and quality of life (QOL) in patients with mPCa.

II. To determine the transcription levels of bone morphogenetic protein -6 (BMP-6) and transforming growth factor-beta (TGF-?).

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive antiandrogen therapy with or without docetaxel at the discretion of the treating physician.

ARM II: Participants receive antiandrogen therapy for at least 1 month, then undergo cytoreductive radical prostatectomy. Participants continue antiandrogen therapy and may receive docetaxel prior to surgery at the discretion of the treating physician.

After completion of study treatment, patients are followed up every 6 months from time of progression.

Connect with a study center

  • Epworth Healthcare

    East Melbourne, 9084
    Australia

    Site Not Available

  • Chinese University of Hong Kong

    Hong Kong,
    China

    Active - Recruiting

  • Kyoto University

    Sako, Kyoto 606-8501
    Japan

    Site Not Available

  • Kindai University

    Ōsaka-sayama, Osaka 589-8511
    Japan

    Active - Recruiting

  • Akita University

    Akita,
    Japan

    Active - Recruiting

  • Juntendo University

    Tokyo,
    Japan

    Active - Recruiting

  • Samsung Medical Center

    Gangnam-gu, Seoul
    Korea, Republic of

    Site Not Available

  • National Cancer Center

    Goyang-si,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Gyeonggi-do,
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei,
    Taiwan

    Active - Recruiting

  • City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • University of California

    Irvine, California 92868
    United States

    Site Not Available

  • University of Southern California

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Yale University

    New Haven, Connecticut 06519
    United States

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08903
    United States

    Active - Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Unniversity of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Terminated

  • Swedish Medical Services

    Seattle, Washington 98104
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.