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A Study to Evaluate Serum Testosterone Levels in Patients With Metastatic Castration-Resistant Prostate Cancer (STAAR)

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ClinicalTrials.gov Identifier: NCT02737332
Recruitment Status : Recruiting
First Posted : April 13, 2016
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):
Churchill Pharmaceutical LLC

Study Description
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Brief Summary:
The purpose of this study is to evaluate the serum testosterone levels in patients with Metastatic Castration-Resistant Prostate Cancer on SoluMatrix™ Abiraterone Acetate as Compared to Abiraterone Acetate

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Zytiga® (Abiraterone Acetate) Drug: SoluMatrix™ (Abiraterone Acetate) Phase 2

Detailed Description:
This is 12-week, open-label study of abiraterone acetate in at least 50 patients with metastatic castration-resistant prostate cancer. The primary endpoint is total testosterone at pharmacokinetic steady-state. Additional secondary endpoints include safety assessments, PSA and pharmacokinetic measurements

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Active-Controlled, Multi-Center Study to Evaluate Serum Testosterone Levels in Patients With Metastatic Castration-Resistant Prostate Cancer: The STAAR STUDY
Study Start Date : February 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Zytiga® (Abiraterone Acetate)
1,000 MG (4 x 250 mg qd)
 Drug: Zytiga® (Abiraterone Acetate)
Zytiga® 1,000 mg (4 x 250 mg qd) Compared to SoluMatrix™ Abiraterone Acetate 500 mg
Other Name: Zytiga®
Experimental: SoluMatrix™ (Abiraterone Acetate)
500 mg (4 x 125 mg qd)
 Drug: SoluMatrix™ (Abiraterone Acetate)
SoluMatrix™ Abiraterone Acetate 500 mg Compared to Zytiga® 1,000 mg (4 x 250 mg qd)
Other Name: SoluMatrix™


Outcome Measures
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Primary Outcome Measures :
  1. Total Testosterone levels by intervention [ Time Frame: Day 10 ]
    Blood Sample


Secondary Outcome Measures :
  1. PSA levels by intervention [ Time Frame: Week 12 ]
    Blood sample

  2. Treatment-emergent adverse events will be calculated for each body system by treatment group. All Serious Adverse Events and Withdrawals due to Adverse events will be reported by intervention [ Time Frame: 12 Weeks ]

Eligibility Criteria
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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:

  1. Written informed consent obtained prior to any study-related procedure being performed
  2. Male subjects at least 18 years of age or older at time of consent
  3. Pathologically confirmed adenocarcinoma of the prostate
  4. Ongoing therapy with a GnRH agonist or antagonist AND serum testosterone level <50 ng/dL at screening
  5. Metastatic disease documented by computed tomography (CT)/ magnetic resonance imaging (MRI) or bone scan. Imaging obtained within 42 days prior to the start of study medication will be accepted.

  6. Meeting disease progression according to the recommendations of the prostate cancer working group 2 by one of the following criteria:

    • Two rises of PSA (taken a minimum of 1 week apart) from a baseline measurement of at least 2 ng/mL,
    • Imaging progression (CT/MRI) by RECIST criteria
    • Nuclear scan progression by new lesion.
  7. Discontinuation of flutamide or nilutamide, and other anti-androgens at least 4 weeks prior to the start of study medication; discontinuation of bicalutamide at least 6 weeks prior to start of study medication.
  8. Discontinuation of Radiotherapy > 4 weeks prior to start of study medication.
  9. ECOG performance status of 0-1 at screening

  10. Screening blood counts of the following:

    • Absolute neutrophil count > 1500/µL
    • Platelets > 100,000/µL
    • Hemoglobin > 9 g/dL

  11. Screening chemistry values of the following:

    • ALT and AST < 2.5 x ULN
    • Total bilirubin < 1.5 x ULN
    • Creatinine< 1.5 x ULN
    • Albumin > 3.0 g/dL
  12. Potassium > 3.5 mmol/L
  13. Life expectancy of at least 6 months at screening
  14. Subject is willing and able to comply with all protocol requirements assessments
  15. Agrees to protocol-defined use of effective contraception.

Exclusion Criteria:

  1. History of impaired pituitary or adrenal gland function
  2. Prior therapy with abiraterone acetate, orteronel, ketoconazole or any other CYP17 inhibitor
  3. Prior therapy with enzalutamide
  4. Prior use of experimental androgen receptor antagonist
  5. Previous exposure to Ra-223:Xofigo
  6. Previous chemotherapy
  7. Initiation of bisphosphonate or denosumab therapy within 30 days prior to the start of study medication. Patients who are on a stable dose of these medications for at least 30 days at the time of starting study drug are eligible.
  8. Therapy with estrogen within 30 days prior to the start of study medication
  9. Use of systemic glucocorticoids equivalent to > 10 mg of prednisone daily; patients who have discontinued or have reduced dose to < 10 mg prednisone within 14 days prior to the start of study medication will be eligible
  10. Prior use of any herbal products that may decrease PSA levels (eg., saw palmetto) within 30 days of start of study medication
  11. Known metastases to the brain or CNS involvement
  12. History of other malignancy within the previous 2 years
  13. Major surgery within 30 days prior to the start of study medication
  14. Blood transfusion within 30 days of screening
  15. Serious, persistent infection within 14 days of the start of study medication
  16. Persistent pain that requires the use of a narcotic analgesic
  17. Known gastrointestinal disease or condition that may impair absorption
  18. Treatment with any investigational drug within 4 weeks prior to Day -1 of the study.
  19. Known history of human immunodeficiency virus (HIV) or seropositive test for hepatitis C virus or hepatitis B virus
  20. Have poorly controlled diabetes.
  21. Uncontrolled hypertension
  22. History of New York Heart Association (NYHA) class III or IV heart failure
  23. Serious concurrent illness, including psychiatric illness, that would interfere with study participation
  24. Inability to swallow tablets whole
  25. Known hypersensitivity to any excipients in study medications
  26. Moderate to severe hepatic impairment (Child-Pugh Classes B and C)
Contacts and Locations
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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): NCT02737332


Contacts
Contact: Paul Nemeth, Ph.D. 610-382-5613 paul@churchillpharma.com

Locations
United States, California
Alliance Research Recruiting
Laguna Hills, California, United States, 92653
Tower Urology Recruiting
Los Angeles, California, United States, 90048
San Bernardino Urological Recruiting
San Bernardino, California, United States, 92404
Contact: Charity Hernandez, LVN    909-881-0555      
Skyline Urology Recruiting
Torrance, California, United States, 90505
Innovative Clinical Research Institute Recruiting
Whittier, California, United States, 90603
Contact: Kristen Bettino, CCRP    562-693-4477      
United States, Colorado
Urology Associates, P.C. Recruiting
Englewood, Colorado, United States, 80113
Contact: Lenden Neeper, MS, CCRP         
United States, Florida
Manatee Medical Research Recruiting
Brandenton, Florida, United States, 34205
Contact: Amy Boucher    941-792-0340 ext 1328      
United States, Idaho
North Idaho Urology Recruiting
Coeur D Alene, Idaho, United States, 83814
Contact: Patti Patterson, RN    208-667-0621      
United States, Iowa
The Iowa Clinic Recruiting
West Des Moines, Iowa, United States, 50266
United States, Kansas
Wichita Urology Group Recruiting
Wichita, Kansas, United States, 67226
Contact: Kris Wheeler, RN, CCRC    316-636-6100    kwheeler@whichitaurology.com   
United States, Maryland
Chesapeake Urology Research Associates Recruiting
Towson, Maryland, United States, 21204
Contact: Jacqueline Huskins    443-471-5750      
United States, Nebraska
Lincoln Urology, PC Recruiting
Lincoln, Nebraska, United States, 68516
Contact: Laura Weber    402-489-8888 ext 224    lauraw@lincolnurologypc.com   
Urology Cancer Center Recruiting
Omaha, Nebraska, United States, 68130
Contact: Diane Tichota    402-991-8468    dtichota@gucancer.com   
United States, New York
Brooklyn Urology Research Group Recruiting
Brooklyn, New York, United States, 11215
United States, North Carolina
Associated Urologist of North Carolina Recruiting
Raleigh, North Carolina, United States, 27612
United States, Texas
Urology Clinics of North Texas Recruiting
Dallas, Texas, United States, 75231
Contact: Yvonne Rivas    214-580-1482      
United States, Virginia
Urology of Virginia Recruiting
Virginia Beach, Virginia, United States, 23462
Contact: Jennifer Kucenski, CCRC    757-452-3462      
Sponsors and Collaborators
Churchill Pharmaceutical LLC
Investigators
Study Director: Paul Nemeth, Ph.D. Churchill Pharmaceutical
More Information
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Responsible Party: Churchill Pharmaceutical LLC
ClinicalTrials.gov Identifier: NCT02737332     History of Changes
Other Study ID Numbers: CHL-AA-201
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Abiraterone Acetate
 Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Cytochrome P-450 Enzyme Inhibitors