NCT02737332
Completed
Phase 2
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
ConditionsProstate Cancer
Overview
- Phase
- Phase 2
- Intervention
- Zytiga® (Abiraterone Acetate)
- Conditions
- Prostate Cancer
- Sponsor
- Sun Pharmaceutical Industries Limited
- Enrollment
- 53
- Locations
- 17
- Primary Endpoint
- Testosterone Levels
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent obtained prior to any study-related procedure being performed
- •Male subjects at least 18 years of age or older at time of consent
- •Pathologically confirmed adenocarcinoma of the prostate
- •Ongoing therapy with a GnRH agonist or antagonist AND serum testosterone level \<50 ng/dL at screening
- •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.
- •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.
- •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.
Exclusion Criteria
- •History of impaired pituitary or adrenal gland function
- •Prior therapy with abiraterone acetate, orteronel, ketoconazole or any other CYP17 inhibitor
- •Prior therapy with enzalutamide
- •Prior use of experimental androgen receptor antagonist
- •Previous exposure to Ra-223:Xofigo
- •Previous chemotherapy
- •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.
- •Therapy with estrogen within 30 days prior to the start of study medication
- •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
- •Prior use of any herbal products that may decrease PSA levels (eg., saw palmetto) within 30 days of start of study medication
Arms & Interventions
Zytiga® (Abiraterone Acetate)
1,000 MG (4 x 250 mg qd)
Intervention: Zytiga® (Abiraterone Acetate)
SoluMatrix™ (Abiraterone Acetate)
500 mg (4 x 125 mg qd)
Intervention: SoluMatrix™ (Abiraterone Acetate)
Outcomes
Primary Outcomes
Testosterone Levels
Time Frame: Average of Day 9 and 10
Blood Sample tested for Serum Testosterone Levels
Secondary Outcomes
- Steady State Trough Concentration of Arbiraterone(Day 09, Day 28, Day 56, and Day 84)
- AUC (0-inf)(60 to 30 minutes prior to dosing and over 24 Hours post-dose)
- AUC (0-24 hr)(60 to 30 minutes prior to dosing and over 24 Hours post-dose)
- AUC (0-t)(60 to 30 minutes prior to dosing and over 24 Hours post-dose)
- Cmax(60 to 30 minutes prior to dosing and over 24 Hours post-dose)
- PSA Levels(Day 28, Day 56, and Day 84)
- Percent of Subjects With PSA-50 Response(Day 28, Day 56, and Day 84)
- Serum Testosterone Levels(Day 28, Day 56, and Day 84)
Study Sites (17)
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