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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03456843
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : March 12, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Isaac Yi Kim, MD, PhD, MBA, Rutgers Cancer Institute of New Jersey

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
Stage IV Prostate Adenocarcinoma AJCC v7 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:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 14, 2018
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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 Name: 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 Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Procedure: Radical Prostatectomy
Undergo cytoreductive radical prostatectomy
Other Name: Prostatovesiculectomy




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Cancer-specific survival [ Time Frame: Up to 2 years ]
  2. Overall complication rate [ Time Frame: Up to 2 years ]
  3. Time to biochemical progression [ Time Frame: Up to 2 years ]
  4. Overall survival [ Time Frame: Through study completion, a minimum of 4 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456843


Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Valerie Mira    626-218-0171    vmira@coh.org   
Principal Investigator: Bertram Yuh, MD         
University of California Recruiting
Irvine, California, United States, 92868
Contact: Linda Huynh    714-456-7354    lindamha@uci.edu   
Contact: Kaelyn See       seek@uci.edu   
Principal Investigator: Thomas E. Ahlering, MD         
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Ileana Aldana    323-865-0702    ileana.aldana@med.usc.edu   
Principal Investigator: Monish Aron, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Deimante Banionyte    773-702-3498    dbanionyte@medicine.bsd.uchicago.edu   
Principal Investigator: Scott Eggener, MD         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Angela Siegwald    502-852-2043    angela.siegwald@louisville.edu   
Principal Investigator: Ahmed Haddad, MD         
United States, New Jersey
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Krystal Hernandez    732-235-2465    kh766@cinj.rutgers.edu   
Principal Investigator: Isaac Y. Kim, MD, PhD         
United States, Pennsylvania
Unniversity of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Ayah El-fahmawi    215-662-9726    ayah.el-fahmawi@pennmedicine.upenn.edu   
Principal Investigator: David I. Lee, MD         
Thomas Jefferson University Terminated
Philadelphia, Pennsylvania, United States, 19107
United States, Washington
Swedish Medical Services Recruiting
Seattle, Washington, United States, 98104
Contact: Adel Islam    206-215-6532    adel.islam@swedish.org   
Principal Investigator: James R. Porter, MD         
Australia
Epworth Healthcare Recruiting
East Melbourne, Australia, 9084
Contact: Thilakavathi Chengodu    (03) 9936 6527    Thili.chengodu@epworth.org.au   
Principal Investigator: Nathan Lawrenrschuk, MD, PhD         
China
Chinese University of Hong Kong Recruiting
Hong Kong, China
Contact: Franco Lai    852-3505-1663    francolai@surgery.cuhk.edu.hk   
Principal Investigator: Chi-Fai Ng, MD         
Japan
Kyoto University Recruiting
Sako, Kyoto, Japan, 606-8501
Contact: Shusuke Akamatsu    075-751-3337    akamats@kuhp.kyoto-u.ac.jp   
Principal Investigator: Osamu Ogawa, MD, PhD         
Kindai University Recruiting
Ōsaka-sayama, Osaka, Japan, 589-8511
Contact: Hirotsugu Uemura, MD, PhD    +81 723660221    huemura@med.kindai.ac.jp   
Principal Investigator: Hirotsugu Uemura, MD, PhD         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Isaac Kim Rutgers Cancer Institute of New Jersey
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Responsible Party: Isaac Yi Kim, MD, PhD, MBA, Professor, Rutgers Cancer Institute of New Jersey
ClinicalTrials.gov Identifier: NCT03456843    
Other Study ID Numbers: 081707
NCI-2018-00047 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
081707 ( Other Identifier: Rutgers Cancer Institute of New Jersey )
P30CA072720 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020

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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:
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Adenocarcinoma
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Ascorbic Acid
Docetaxel
Methyltestosterone
Hormones
Estrogens, Conjugated (USP)
Androgens
Androgen Antagonists
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antioxidants
Protective Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Estrogens
Antineoplastic Agents, Hormonal
Anabolic Agents
Hormone Antagonists