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

Description

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.

Conditions

Stage IV Prostate Adenocarcinoma AJCC v7

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Study Overview

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Study Details

Study overview

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.

SIMCAP (Surgery in Metastatic Carcinoma of Prostate): Phase 2.5 Multi-Institution Randomized Prospective Clinical Trial Evaluating the Impact of Cytoreductive Radical Prostatectomy Combined With Best Systemic Therapy on Oncologic and Quality of Life Outcomes in Men With Newly Diagnosed Metastatic Prostate Cancer

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

Condition
Stage IV Prostate Adenocarcinoma AJCC v7
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope, Duarte, California, United States, 91010

Irvine

University of California, Irvine, California, United States, 92868

Los Angeles

University of Southern California, Los Angeles, California, United States, 90033

New Haven

Yale University, New Haven, Connecticut, United States, 06519

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Louisville

University of Louisville, Louisville, Kentucky, United States, 40202

New Brunswick

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States, 08903

Philadelphia

Unniversity of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Philadelphia

Thomas Jefferson University, Philadelphia, Pennsylvania, United States, 19107

Seattle

Swedish Medical Services, Seattle, Washington, United States, 98104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 independent imaging modalities (i.e. CT and PET \[positron emission tomography\], bone scan and MRI, 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 6 months 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 for surgery
  • * Alanine aminotransferase (ALT) =\< 2x upper limit of normal (ULN) compatible for surgery
  • * 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 to consent
  • * Previous local therapy for prostate cancer
  • * Patients who have chemotherapy or radiotherapy for non-prostate cancer related treatment within 3 weeks prior to consent

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Yale University,

Isaac Kim, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

2027-03