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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 : Completed
First Posted : April 13, 2016
Results First Posted : August 12, 2020
Last Update Posted : February 12, 2021
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Global FZE

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 was a 12-week, open-label study of abiraterone acetate in at least 50 patients with metastatic castration-resistant prostate cancer.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 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
Actual Study Start Date : March 21, 2016
Actual Primary Completion Date : February 27, 2017
Actual Study Completion Date : February 27, 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) tablets plus one 5 mg prednisone tablet to be taken bid, spaced approximately 12 hours apart
Other Name: Zytiga®
Experimental: SoluMatrix™ (Abiraterone Acetate)
500 mg (4 x 125 mg qd)
 Drug: SoluMatrix™ (Abiraterone Acetate)
SoluMatrix™ 500 mg (4 x 125 mg qd) tablets plus one 4 mg methylprednisolone tablet bid, spaced approximately 12 hours apart
Other Name: SoluMatrix™


Outcome Measures
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Primary Outcome Measures :
  1. Testosterone Levels [ Time Frame: Average of Day 9 and 10 ]
    Blood Sample tested for Serum Testosterone Levels


Secondary Outcome Measures :
  1. PSA Levels [ Time Frame: Day 28, Day 56, and Day 84 ]

    All patients randomized to one of the two treatment groups, round about level of PSA.

    These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint


  2. Percent of Subjects With PSA-50 Response [ Time Frame: Day 28, Day 56, and Day 84 ]

    Proportion of patients with complete suppression of PSA-50 were reported by treatment and compared for between-group differences.

    These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.


  3. Serum Testosterone Levels [ Time Frame: Day 28, Day 56, and Day 84 ]
    These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.

  4. Steady State Trough Concentration of Arbiraterone [ Time Frame: Day 09, Day 28, Day 56, and Day 84 ]
    These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.

  5. AUC (0-inf) [ Time Frame: 60 to 30 minutes prior to dosing and over 24 Hours post-dose ]
    Steady state systemic exposure parameters

  6. AUC (0-24 hr) [ Time Frame: 60 to 30 minutes prior to dosing and over 24 Hours post-dose ]
    Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr).

  7. AUC (0-t) [ Time Frame: 60 to 30 minutes prior to dosing and over 24 Hours post-dose ]
    Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr).

  8. Cmax [ Time Frame: 60 to 30 minutes prior to dosing and over 24 Hours post-dose ]
    Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr).


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


Locations
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Sponsors and Collaborators
Sun Pharma Global FZE
Investigators
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Study Director: Paul Nemeth, PhD
  Study Documents (Full-Text)

Documents provided by Sun Pharma Global FZE:
Study Protocol and Statistical Analysis Plan  [PDF] October 10, 2016

More Information
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Responsible Party: Sun Pharma Global FZE
ClinicalTrials.gov Identifier: NCT02737332    
Other Study ID Numbers: CHL-AA-201
First Posted: April 13, 2016    Key Record Dates
Results First Posted: August 12, 2020
Last Update Posted: February 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Abiraterone Acetate
Antineoplastic Agents
 Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 Enzyme Inhibitors