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Trial record 71 of 154 for:    Recruiting, Not yet recruiting, Available Studies | Prostatectomy

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

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ClinicalTrials.gov Identifier: NCT03456843
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : September 11, 2019
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 M1a or M1b 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 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.


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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 within 3 months after 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

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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), 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

Exclusion Criteria:

  • 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

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    626-256-4673    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: Monish Aron, MD    323-865-3700    monish.aron@med.usc.edu   
Principal Investigator: Monish Aron, MD         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Angela Bryant    502-588-4740    angela.bryant@louisville.edu   
Contact: Molly Brown       molly.brown@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: Isaac Y. Kim    732-235-2043    kimiy@cinj.rutgers.edu   
Principal Investigator: Isaac Y. Kim         
United States, Pennsylvania
Unniversity of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jessica Kim    855-216-0098    Jessica.kim3@uphs.upenn.edu   
Contact: Hanna Stambakio       hanna.stambakio@uphs.upenn.edu   
Principal Investigator: David I. Lee, MD         
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Edouard T. Trabulsi, MD    215-955-1000    Edouard.Trabulsi@jefferson.edu   
Contact: Sophia Hines, BS    215-955-0030    sophia.hines@jefferson.edu   
Principal Investigator: Edouard T. Trabulsi, MD         
United States, Washington
Swedish Medical Services Recruiting
Seattle, Washington, United States, 98104
Contact: Meg Baker    855-922-6237    meg.baker@swedish.org   
Contact: Adel Islam       adel.islam@swedish.org   
Principal Investigator: James R. Porter, MD         
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, Associate Professor, Rutgers Cancer Institute of New Jersey
ClinicalTrials.gov Identifier: NCT03456843     History of Changes
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: September 11, 2019
Last Verified: September 2019

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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
Docetaxel
Hormones
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
Hormone Antagonists