Summary

for males ages 18 years and up (full criteria)
at Irvine, California and other locations
study started
estimated completion
Thomas E. Ahlering, MD

Description

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.

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

Details

PRIMARY OBJECTIVES:

  1. 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 M1a or M1b metastatic prostate cancer (mPCa).

SECONDARY OBJECTIVES:

  1. 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 within 3 months after surgery at the discretion of the treating physician.

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

Keywords

Stage IV Prostate Adenocarcinoma AJCC v7 Adenocarcinoma Docetaxel Hormones Androgens Androgen Antagonists Antiandrogen Therapy Laboratory Biomarker Analysis Quality-of-Life Assessment Radical Prostatectomy

Eligibility

You can join if…

Open to males ages 18 years and up

  • 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), or M1b (bone 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
  • Give informed consent
  • Prostate deemed resectable by surgeon
  • Started antiandrogen therapy (ADT) no longer than 6 months prior to randomization
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Hemoglobin (HgB) >= 9 g/dL compatible for surgery
  • Platelets > 80,000 compatible for surgery
  • Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) =< 2x upper limit of normal (ULN) compatible for surgery

You CAN'T join if...

  • Refuses to give informed consent
  • Deemed to have unresectable disease by surgeon
  • Received ADT for more than 6 months prior to randomization
  • Life expectancy of less than 6 months prior to randomization
  • Known spinal cord compression
  • M1c disease (solid organ metastasis)
  • Deep vein thrombosis (DVT) / pulmonary embolism (PE) in the past 6 months prior to randomization
  • Previous local therapy for prostate cancer
  • Previous chemotherapy for prostate cancer
  • Patients who have chemotherapy, radiotherapy or oral antifungal agents (ketoconazole, itraconazole, fluconazole) within 3 weeks prior to entering the study or those who have not recovered (e.g. back to baseline or grade 1) from adverse events due to agents administered more than 3 weeks earlier
  • Any drug interactions that are deemed to be medically significant would require a washout of 5-half-lives of the interaction agent before enrollment can occur

Locations

  • University of California accepting new patients
    Irvine California 92868 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States
  • University of Southern California accepting new patients
    Los Angeles California 90033 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Rutgers, The State University of New Jersey
ID
NCT03456843
Phase
Phase 2
Study Type
Interventional
Last Updated