Clinical Trial of a Rapidly Cycling, Non-Cross Reactive Regimen of Approved Therapeutic Agents to Treat Prostate Cancer

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Clinical Trial of a Rapidly Cycling, Non-Cross Reactive Regimen of Approved Therapeutic Agents to Treat Prostate Cancer

Condition: Prostate Cancer

Intervention:

  • Drug: Abiraterone acetate
  • Drug: Prednisone
  • Drug: Radium-223 dichloride
  • Drug: cabazitaxel
  • Drug: Carboplatin
  • Drug: Enzalutamide

Purpose: The purpose of this study is to determine the clinical benefits of using a rapidly cycling, non-cross reactive regimen of FDA-approved prostate cancer therapeutic agents in the management of castration resistant prostate cancer. The hypothesis is that the identification of optimal combinations and sequencing of therapies can help prevent or delay the development of therapeutic drug resistance, and can be safely tolerated.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02903160

Sponsor: Icahn School of Medicine at Mount Sinai

Primary Outcome Measures:

  • Measure: Time to disease progression
  • Time Frame: average 24 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Overall survival
  • Time Frame: up to 24 months
  • Safety Issue:
  • Measure: PSA response rate
  • Time Frame: up to 24 months
  • Safety Issue:
  • Measure: Changes to alkaline phosphatase levels
  • Time Frame: baseline and 24 months
  • Safety Issue:

Estimated Enrollment: 40

Study Start Date: January 13, 2017

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Metastatic castrate resistant prostate cancer, defined by progressive disease based on either rising PSA, new bone metastases, or progression of measurable disease on standard imaging, according to PCWG2 guidelines, despite androgen deprivation therapy
  • Ongoing androgen deprivation therapy with a GnRH analogue, GnRH antagonist, or bilateral orchiectomy
  • ECOG performance status 0-1
  • Serum testosterone level < 50 ng/dL
  • Absolute neutrophil count > 1,500/μL, platelet count > 100,000/μL, and hemoglobin > 9 g/dL
  • Creatinine < 2 mg/dL
  • Total bilirubin < 1 times the upper limit of normal, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 1.5 times the upper limit of normal

Exclusion Criteria:

  • History of uncontrolled seizure disorder
  • Clinically significant cardiovascular disease including: 1. Myocardial infarction or uncontrolled angina within 6 months 2. Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patients with history of congestive heart failure NYHA class 3 or 4 in the past 3. Uncontrolled hypertension as indicated by a resting systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the screening visit
  • Have used or plan to use from 30 days prior to enrollment through the end of the study medication known to lower the seizure threshold or prolong the QT interval
  • Major surgery within 4 weeks of enrollment
  • Radiation therapy within 4 weeks of enrollment
  • Prior use of abiraterone acetate, enzalutamide, docetaxel, cabazitaxel, carboplatin, or radium-223 for the treatment of castration-resistant disease
  • Prior docetaxel use in the hormone-sensitive disease setting is allowed, but must be completed ≥ 4 weeks prior to enrollment
  • Prior sipuleucel-T use is allowed, but must be completed ≥ 4 weeks prior to enrollment
  • Concurrent use of zoledronic acid or denosumab is allowed on study

Contact:

  • Bobby Liaw, MD
  • 212-604-6010

Locations:

  • Mount Sinai Beth Israel
  • New York New York 10011 United States
  • Mount Sinai West
  • New York New York 10019 United States
  • Icahn School of Medicine at Mount Sinai
  • New York New York 10028 United States

View trial on ClinicalTrials.gov

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