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

Prostate Cancer Clinical Trial

— STAAR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02737332
• Other study ID #: CHL-AA-201
• Status: Completed
• Phase: Phase 2
• Start date: March 21, 2016
• Est. completion date: February 27, 2017

Study information

• Verified date: November 2021
• Source: Sun Pharmaceutical Industries Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

This was a 12-week, open-label study of abiraterone acetate in at least 50 patients with metastatic castration-resistant prostate cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 27, 2017
• Est. primary completion date: February 27, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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
• SoluMatrix™ (Abiraterone Acetate)
SoluMatrix™ 500 mg (4 x 125 mg qd) tablets plus one 4 mg methylprednisolone tablet bid, spaced approximately 12 hours apart

Locations

Country	Name	City	State
United States	Manatee Medical Research	Bradenton	Florida
United States	Brooklyn Urology Research Group	Brooklyn	New York
United States	North Idaho Urology	Coeur d'Alene	Idaho
United States	Urology Clinics of North Texas	Dallas	Texas
United States	Urology Associates, P.C.	Englewood	Colorado
United States	Alliance Research	Laguna Hills	California
United States	Lincoln Urology, PC	Lincoln	Nebraska
United States	Tower Urology	Los Angeles	California
United States	Urology Cancer Center	Omaha	Nebraska
United States	Associated Urologist of North Carolina	Raleigh	North Carolina
United States	San Bernardino Urological	San Bernardino	California
United States	Skyline Urology	Torrance	California
United States	Chesapeake Urology Research Associates	Towson	Maryland
United States	Urology of Virginia	Virginia Beach	Virginia
United States	The Iowa Clinic	West Des Moines	Iowa
United States	Innovative Clinical Research Institute	Whittier	California
United States	Wichita Urology Group	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharmaceutical Industries Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Testosterone Levels	Blood Sample tested for Serum Testosterone Levels	Average of Day 9 and 10
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	AUC (0-inf)	Steady state systemic exposure parameters	60 to 30 minutes prior to dosing and over 24 Hours post-dose
Secondary	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
Secondary	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
Secondary	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