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

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

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

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Zytiga® (Abiraterone Acetate); Drug: SoluMatrix™ (Abiraterone Acetate)

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 Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Laguna Hills, California, United States, 92653
      • Alliance Research
    • Los Angeles, California, United States, 90048
      • Tower Urology
    • San Bernardino, California, United States, 92404
      • San Bernardino Urological
    • Torrance, California, United States, 90505
      • Skyline Urology
    • Whittier, California, United States, 90603
      • Innovative Clinical Research Institute
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Urology Associates, P.C.
  • Florida
    • Bradenton, Florida, United States, 34205
      • Manatee Medical Research
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • North Idaho Urology
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • The Iowa Clinic
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Wichita Urology Group
  • Maryland
    • Towson, Maryland, United States, 21204
      • Chesapeake Urology Research Associates
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Lincoln Urology, PC
    • Omaha, Nebraska, United States, 68130
      • Urology Cancer Center
  • New York
    • Brooklyn, New York, United States, 11215
      • Brooklyn Urology Research Group
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Associated Urologist of North Carolina
  • Texas
    • Dallas, Texas, United States, 75231
      • Urology Clinics of North Texas
  • Virginia
    • Virginia Beach, Virginia, United States, 23462
      • Urology of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: SoluMatrix™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Testosterone Levels	Blood Sample tested for Serum Testosterone Levels	Average of Day 9 and 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSA Levels	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	Day 28, Day 56, and Day 84
Percent of Subjects With PSA-50 Response	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.	Day 28, Day 56, and Day 84
Serum Testosterone Levels	These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.	Day 28, Day 56, and Day 84
Steady State Trough Concentration of Arbiraterone	These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.	Day 09, Day 28, Day 56, and Day 84
AUC (0-inf)	Steady state systemic exposure parameters	60 to 30 minutes prior to dosing and over 24 Hours post-dose
AUC (0-24 hr)	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).	60 to 30 minutes prior to dosing and over 24 Hours post-dose
AUC (0-t)	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).	60 to 30 minutes prior to dosing and over 24 Hours post-dose
Cmax	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).	60 to 30 minutes prior to dosing and over 24 Hours post-dose

Collaborators and Investigators

• Sponsor: Sun Pharmaceutical Industries Limited
• Investigators: Study Director: Paul Nemeth, PhD

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2016
• Primary Completion (Actual): February 27, 2017
• Study Completion (Actual): February 27, 2017

Study Registration Dates

• First Submitted: March 25, 2016
• First Submitted That Met QC Criteria: April 12, 2016
• First Posted (Estimate): April 13, 2016

Study Record Updates

• Last Update Posted (Actual): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 19, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; Abiraterone Acetate
• Other Study ID Numbers: CHL-AA-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No