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Hormone Therapy

SoluMatrix™ (Abiraterone Acetate) for Prostate Cancer (STAAR Trial)

Phase 2
Waitlist Available
Research Sponsored by Sun Pharma Global FZE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 09, day 28, day 56, and day 84
Awards & highlights
No Placebo-Only Group

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

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 09, day 28, day 56, and day 84
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 09, day 28, day 56, and day 84 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Testosterone Levels
Secondary study objectives
AUC (0-24 hr)
AUC (0-inf)
AUC (0-t)
+5 more

Side effects data

From 2017 Phase 2 trial • 53 Patients • NCT02737332
14%
Back pain
14%
Muscle spasms
14%
Dizziness
10%
Nausea
10%
Urinary tract infections
7%
Asthenia
7%
Blood creatiineincreased
7%
Muscular weakness
7%
Vomiting
7%
Hypertension
3%
Progression of prostate cancer
3%
Myocardial infarction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Zytiga® (Abiraterone Acetate)
SoluMatrix™ (Abiraterone Acetate)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SoluMatrix™ (Abiraterone Acetate)Experimental Treatment1 Intervention
500 mg (4 x 125 mg qd)
Group II: Zytiga® (Abiraterone Acetate)Active Control1 Intervention
1,000 MG (4 x 250 mg qd)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SoluMatrix™ (Abiraterone Acetate)
2016
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Sun Pharma Global FZELead Sponsor
33 Previous Clinical Trials
10,098 Total Patients Enrolled
Sun Pharmaceutical Industries LimitedLead Sponsor
69 Previous Clinical Trials
13,742 Total Patients Enrolled
Paul Nemeth, PhDStudy Director
~6 spots leftby Nov 2025
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