A Study to Evaluate Serum Testosterone Levels in Patients With Metastatic Castration-Resistant Prostate Cancer
STAAR
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
1 other identifier
interventional
53
1 country
17
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 prostate-cancer
Started Mar 2016
Shorter than P25 for phase_2 prostate-cancer
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 21, 2016
CompletedFirst Submitted
Initial submission to the registry
March 25, 2016
CompletedFirst Posted
Study publicly available on registry
April 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2017
CompletedResults Posted
Study results publicly available
August 12, 2020
CompletedNovember 22, 2021
November 1, 2021
11 months
March 25, 2016
May 2, 2019
November 19, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Testosterone Levels
Blood Sample tested for Serum Testosterone Levels
Average of Day 9 and 10
Secondary Outcomes (8)
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
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
- +3 more secondary outcomes
Study Arms (2)
Zytiga® (Abiraterone Acetate)
ACTIVE COMPARATOR1,000 MG (4 x 250 mg qd)
SoluMatrix™ (Abiraterone Acetate)
EXPERIMENTAL500 mg (4 x 125 mg qd)
Interventions
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™ 500 mg (4 x 125 mg qd) tablets plus one 4 mg methylprednisolone tablet bid, spaced approximately 12 hours apart
Eligibility Criteria
You may qualify if:
- 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.
- Discontinuation of Radiotherapy \> 4 weeks prior to start of study medication.
- ECOG performance status of 0-1 at screening
- Screening blood counts of the following:
- Absolute neutrophil count \> 1500/µL
- Platelets \> 100,000/µL
- +10 more criteria
You may not qualify if:
- 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
- Known metastases to the brain or CNS involvement
- History of other malignancy within the previous 2 years
- Major surgery within 30 days prior to the start of study medication
- Blood transfusion within 30 days of screening
- Serious, persistent infection within 14 days of the start of study medication
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Alliance Research
Laguna Hills, California, 92653, United States
Tower Urology
Los Angeles, California, 90048, United States
San Bernardino Urological
San Bernardino, California, 92404, United States
Skyline Urology
Torrance, California, 90505, United States
Innovative Clinical Research Institute
Whittier, California, 90603, United States
Urology Associates, P.C.
Englewood, Colorado, 80113, United States
Manatee Medical Research
Bradenton, Florida, 34205, United States
North Idaho Urology
Coeur d'Alene, Idaho, 83814, United States
The Iowa Clinic
West Des Moines, Iowa, 50266, United States
Wichita Urology Group
Wichita, Kansas, 67226, United States
Chesapeake Urology Research Associates
Towson, Maryland, 21204, United States
Lincoln Urology, PC
Lincoln, Nebraska, 68516, United States
Urology Cancer Center
Omaha, Nebraska, 68130, United States
Brooklyn Urology Research Group
Brooklyn, New York, 11215, United States
Associated Urologist of North Carolina
Raleigh, North Carolina, 27612, United States
Urology Clinics of North Texas
Dallas, Texas, 75231, United States
Urology of Virginia
Virginia Beach, Virginia, 23462, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head, Clinical Development
- Organization
- SPARC
Study Officials
- STUDY DIRECTOR
Paul Nemeth, PhD
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2016
First Posted
April 13, 2016
Study Start
March 21, 2016
Primary Completion
February 27, 2017
Study Completion
February 27, 2017
Last Updated
November 22, 2021
Results First Posted
August 12, 2020
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share