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

January 10, 2024 updated by: Yale University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

190

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • East Melbourne, Australia, 9084
        • Recruiting
        • Epworth Healthcare
        • Contact:
        • Principal Investigator:
          • Nathan Lawrenrschuk, MD, PhD
  • China
  • Japan
      • Akita, Japan
        • Recruiting
        • Akita University
        • Contact:
        • Principal Investigator:
          • Shintaro Narita, MD, PhD
      • Tokyo, Japan
        • Recruiting
        • Juntendo University
        • Contact:
        • Principal Investigator:
          • Shigeo Horie, MD, PhD
    • Kyoto
      • Sako, Kyoto, Japan, 606-8501
        • Withdrawn
        • Kyoto University
    • Osaka
      • Ōsaka-sayama, Osaka, Japan, 589-8511
        • Recruiting
        • Kindai University
        • Contact:
        • Principal Investigator:
          • Hirotsugu Uemura, MD, PhD
  • Korea, Republic of
      • Goyang-si, Korea, Republic of
        • Recruiting
        • National Cancer Center
        • Contact:
        • Principal Investigator:
          • Jae Young Joung, MD, PhD
      • Gyeonggi-do, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Principal Investigator:
          • Seok-Soo Byun, MD
  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Principal Investigator:
          • Jeff Chueh, MD,PhD
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Contact:
        • Principal Investigator:
          • Bertram Yuh, MD
      • Irvine, California, United States, 92868
        • Withdrawn
        • University of California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California
        • Principal Investigator:
          • Monish Aron, MD
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Yale University
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Terminated
        • University of Chicago
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Terminated
        • University of Louisville
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Contact:
        • Principal Investigator:
          • Saum Ghodoussipour, MD, PhD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Terminated
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19104
        • Terminated
        • Unniversity of Pennsylvania
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Swedish Medical Services
        • Contact:
        • Principal Investigator:
          • James R. Porter, MD

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (ADT, docetaxel)
Participants receive antiandrogen therapy with or without docetaxel at the discretion of the treating physician.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Questionnaire Administration
Ancillary studies
Procedure: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
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:
  • Taxotere
  • Docecad
  • RP56976
  • Taxotere Injection Concentrate
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.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Questionnaire Administration
Ancillary studies
Procedure: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
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:
  • Taxotere
  • Docecad
  • RP56976
  • Taxotere Injection Concentrate
Procedure: Radical Prostatectomy
Undergo cytoreductive radical prostatectomy
Other Names:
  • Prostatovesiculectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure-free survival (FFS)
Time Frame: 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.
At 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Cancer-specific survival
Time Frame: Up to 2 years
Up to 2 years
Overall complication rate
Time Frame: Up to 2 years
Up to 2 years
Time to biochemical progression
Time Frame: Up to 2 years
Up to 2 years
Overall survival
Time Frame: Through study completion, a minimum of 4 years
Through study completion, a minimum of 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Isaac Kim, 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 Major Dates

Study Start (Actual)

March 14, 2018

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

February 20, 2018

First Submitted That Met QC Criteria

February 28, 2018

First Posted (Actual)

March 7, 2018

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000031290
  • P30CA072720 (U.S. NIH Grant/Contract)
  • NCI-2018-00047 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 081707 (Other Identifier: Rutgers Cancer Institute of New Jersey)
  • Pro20170001506 (Other Identifier: WIRB)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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