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Hormone Therapy
A Study to Evaluate Serum Testosterone Levels in Patients With Metastatic Castration-Resistant 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 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 09, day 28, day 56, and day 84
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 09, day 28, day 56, and day 84
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 moreSide effects data
From 2017 Phase 2 trial • 53 Patients • NCT0273733217%
Urinary tract infections
8%
Abdominal pain
8%
Oedema peripheral
4%
Gastroesophgeal reflux disease
4%
Thirst
4%
Bacteriuria
4%
Vertigo
4%
Worsening of left hydroureteronephrosis
4%
Back pain
4%
Muscle spasms
4%
Night sweats
4%
Cellulitis
4%
Hypertension
4%
Corornary artery disease
4%
Sepsis
4%
Pyelonephritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
SoluMatrix™ (Abiraterone Acetate)
Zytiga® (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
10,096 Total Patients Enrolled
Sun Pharmaceutical Industries LimitedLead Sponsor
69 Previous Clinical Trials
13,763 Total Patients Enrolled
Paul Nemeth, PhDStudy Director