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

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Zytiga® (Abiraterone Acetate); Drug: SoluMatrix™ (Abiraterone Acetate)

• Registration Number: NCT02737332
• Lead Sponsor: Sun Pharmaceutical Industries Limited

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

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 Timeline

• Study Start: 2016-03-21
• Study First Submitted: 2016-03-25
• Study First Submitted QC: 2016-04-12
• Study First Posted: 2016-04-13
• Primary Completion: 2017-02-27
• Study Completion: 2017-02-27
• Results First Submitted: 2019-05-02
• Results First Submitted QC: 2020-07-27
• Results First Posted: 2020-08-12
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-19
• Last Update Posted: 2021-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 53

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zytiga® (Abiraterone Acetate)	Zytiga® (Abiraterone Acetate)	1,000 MG (4 x 250 mg qd)
SoluMatrix™ (Abiraterone Acetate)	SoluMatrix™ (Abiraterone Acetate)	500 mg (4 x 125 mg qd)

Primary Outcome Measures

Name	Time	Method
Testosterone Levels	Average of Day 9 and 10	Blood Sample tested for Serum Testosterone Levels

Secondary Outcome Measures

Name	Time	Method
Steady State Trough Concentration of Arbiraterone	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.
AUC (0-inf)	60 to 30 minutes prior to dosing and over 24 Hours post-dose	Steady state systemic exposure parameters
AUC (0-24 hr)	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).
AUC (0-t)	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).
Cmax	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).
PSA Levels	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
Percent of Subjects With PSA-50 Response	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.
Serum Testosterone Levels	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.

Trial Locations

Locations (17)

North Idaho Urology; 🇺🇸 Coeur d'Alene, Idaho, United States

Chesapeake Urology Research Associates; 🇺🇸 Towson, Maryland, United States

Lincoln Urology, PC; 🇺🇸 Lincoln, Nebraska, United States

Wichita Urology Group; 🇺🇸 Wichita, Kansas, United States

Urology Associates, P.C.; 🇺🇸 Englewood, Colorado, United States

Alliance Research; 🇺🇸 Laguna Hills, California, United States

Tower Urology; 🇺🇸 Los Angeles, California, United States

Skyline Urology; 🇺🇸 Torrance, California, United States

San Bernardino Urological; 🇺🇸 San Bernardino, California, United States

Innovative Clinical Research Institute; 🇺🇸 Whittier, California, United States

Manatee Medical Research; 🇺🇸 Bradenton, Florida, United States

The Iowa Clinic; 🇺🇸 West Des Moines, Iowa, United States

Urology Cancer Center; 🇺🇸 Omaha, Nebraska, United States

Brooklyn Urology Research Group; 🇺🇸 Brooklyn, New York, United States

Associated Urologist of North Carolina; 🇺🇸 Raleigh, North Carolina, United States

Urology Clinics of North Texas; 🇺🇸 Dallas, Texas, United States

Urology of Virginia; 🇺🇸 Virginia Beach, Virginia, United States