ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2018-03-20
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03456843

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically proven adenocarcinoma of the prostate
  2. * Evidence of metastasis by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histologic confirmation
  3. * Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (solid organ metastasis.
  4. * 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)
  5. * No previous local therapy for prostate cancer (i.e prostate radiation, cryotherapy, etc.)
  6. * Give informed consent
  7. * Prostate deemed resectable by surgeon
  8. * Plans to start or has already started antiandrogen therapy (ADT) no longer than 6 months prior to consent
  9. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  10. * Hemoglobin (HgB) \>= 9 g/dL compatible for surgery
  11. * Platelets \> 80,000/mcL compatible for surgery
  12. * Aspartate aminotransferase (AST) =\< 2x upper limit of normal (ULN) compatible for surgery
  13. * Alanine aminotransferase (ALT) =\< 2x upper limit of normal (ULN) compatible for surgery
  1. * Refuses to give informed consent
  2. * Deemed to have unresectable disease by surgeon
  3. * Received ADT for more than 6 months prior to consent
  4. * Life expectancy of less than 6 months prior to consent
  5. * Active spinal cord compression
  6. * Deep vein thrombosis (DVT) / pulmonary embolism (PE) in the past 6 months prior to consent
  7. * Previous local therapy for prostate cancer
  8. * Patients who have chemotherapy or radiotherapy for non-prostate cancer related treatment within 3 weeks prior to consent

Contacts and Locations

Principal Investigator

Isaac Kim, MD
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

City of Hope
Duarte, California, 91010
United States
University of California, Irvine
Irvine, California, 92697
United States
University of Southern California
Los Angeles, California, 90033
United States
Yale University
New Haven, Connecticut, 06519
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Swedish Medical Services
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: Yale University

  • Isaac Kim, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-03-20
Study Completion Date2027-03

Study Record Updates

Study Start Date2018-03-20
Study Completion Date2027-03

Terms related to this study

Additional Relevant MeSH Terms

  • Stage IV Prostate Adenocarcinoma AJCC v7