Clincosm LogoSign in Get a demo

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

Sponsor
Yale University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03456843
Collaborator
National Cancer Institute (NCI) (NIH)
190
Enrollment
14
Locations
2
Arms
53.6
Anticipated Duration (Months)
13.6
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Antiandrogen Therapy
  • Drug: Docetaxel
  • Other: Laboratory Biomarker Analysis
  • Procedure: Quality-of-Life Assessment
  • Other: Questionnaire Administration
  • Procedure: Radical Prostatectomy
 Phase 2

Detailed Description

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 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.

  2. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
190 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 14, 2018
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I (ADT, docetaxel)

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

Drug: Antiandrogen Therapy
To demonstrate at least 30% improvement in FFS at 2 years after randomization with the power of 90% and error of 5% on a one-sided exponential MLE test.
Other Names:
  • ADT
  • Androgen Deprivation Therapy
  • Anti-androgen Therapy
  • Anti-androgen Treatment
  • Antiandrogen Treatment
  • Hormone Deprivation Therapy
  • Hormone-Deprivation Therapy

    • Drug: Docetaxel
    To demonstrate at least 30% improvement in FFS at 2 years after randomization with the power of 90% and error of 5% on a one-sided exponential MLE test.
    Other Names:
  • Docecad
  • RP56976
  • Taxotere
  • Taxotere Injection Concentrate

    • Other: Laboratory Biomarker Analysis
    Correlative studies

    Procedure: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    • Other: Questionnaire Administration
    Ancillary studies
    Experimental: Arm II (ADT, radical prostatectomy, docetaxel)

    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.

    Drug: Antiandrogen Therapy
    To demonstrate at least 30% improvement in FFS at 2 years after randomization with the power of 90% and error of 5% on a one-sided exponential MLE test.
    Other Names:
  • ADT
  • Androgen Deprivation Therapy
  • Anti-androgen Therapy
  • Anti-androgen Treatment
  • Antiandrogen Treatment
  • Hormone Deprivation Therapy
  • Hormone-Deprivation Therapy

    • Drug: Docetaxel
    To demonstrate at least 30% improvement in FFS at 2 years after randomization with the power of 90% and error of 5% on a one-sided exponential MLE test.
    Other Names:
  • Docecad
  • RP56976
  • Taxotere
  • Taxotere Injection Concentrate

    • Other: Laboratory Biomarker Analysis
    Correlative studies

    Procedure: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    • Other: Questionnaire Administration
    Ancillary studies

    Procedure: Radical Prostatectomy
    Undergo cytoreductive radical prostatectomy
    Other Names:
  • Prostatovesiculectomy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Failure-free survival (FFS) [At 2 years]

      Failure is defined as any one of the following events: PSA progression, clinical progression, radiographic progression, or death from prostate cancer. The % of men who fail within 2 years of randomization will be compare between the two groups using a one-sided log-rank test.

    Secondary Outcome Measures

    1. Cancer-specific survival [Up to 2 years]

    2. Overall complication rate [Up to 2 years]

    3. Time to biochemical progression [Up to 2 years]

    4. Overall survival [Through study completion, a minimum of 4 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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 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

    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

    • Known 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Duarte California United States 91010
    2 University of California Irvine California United States 92868
    3 University of Southern California Los Angeles California United States 90033
    4 Yale University New Haven Connecticut United States 06519
    5 University of Chicago Chicago Illinois United States 60637
    6 University of Louisville Louisville Kentucky United States 40202
    7 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08903
    8 Unniversity of Pennsylvania Philadelphia Pennsylvania United States 19104
    9 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
    10 Swedish Medical Services Seattle Washington United States 98104
    11 Epworth Healthcare East Melbourne Australia 9084
    12 Chinese University of Hong Kong Hong Kong China
    13 Kyoto University Sako Kyoto Japan 606-8501
    14 Kindai University Ōsaka-sayama Osaka Japan 589-8511

    Sponsors and Collaborators

    • Yale University
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Isaac Kim, Yale University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yale University
    ClinicalTrials.gov Identifier:
    NCT03456843
    Other Study ID Numbers:
    • 2000031290
    • NCI-2018-00047
    • 081707
    • P30CA072720
    • Pro20170001506
    First Posted:
    Mar 7, 2018
    Last Update Posted:
    Feb 25, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Adenocarcinoma
    Ascorbic Acid
    Docetaxel
    Methyltestosterone
    Hormones
    Estrogens, Conjugated (USP)
    Androgens
    Androgen Antagonists

    Study Results

    No Results Posted as of Feb 25, 2022