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Prostate CancerPhase 2STAARNCT02737332

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

A Phase 2 study testing Zytiga® (Abiraterone Acetate) and SoluMatrix™ (Abiraterone Acetate) in people with Prostate Cancer, run by Sun Pharmaceutical Industries Limited at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Zytiga® (Abiraterone Acetate) and SoluMatrix™ (Abiraterone Acetate)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
17 sitesUnited States
Study dates
21 Mar 2016to 27 Feb 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 25Show fewer
  • 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
  • Hemoglobin > 9 g/dL
  • 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
  • Potassium > 3.5 mmol/L
  • Life expectancy of at least 6 months at screening
  • Subject is willing and able to comply with all protocol requirements assessments
  • Agrees to protocol-defined use of effective contraception.

Who cannot join

  • 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
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  • 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
  • Persistent pain that requires the use of a narcotic analgesic
  • Known gastrointestinal disease or condition that may impair absorption
  • Treatment with any investigational drug within 4 weeks prior to Day -1 of the study.
  • Known history of human immunodeficiency virus (HIV) or seropositive test for hepatitis C virus or hepatitis B virus
  • Have poorly controlled diabetes.
  • Uncontrolled hypertension
  • History of New York Heart Association (NYHA) class III or IV heart failure
  • Serious concurrent illness, including psychiatric illness, that would interfere with study participation
  • Inability to swallow tablets whole
  • Known hypersensitivity to any excipients in study medications
  • Moderate to severe hepatic impairment (Child-Pugh Classes B and C)

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Manatee Medical Research

    Bradenton, Florida, 34205

  • Brooklyn Urology Research Group

    Brooklyn, New York, 11215

  • North Idaho Urology

    Coeur d'Alene, Idaho, 83814

  • Urology Clinics of North Texas

    Dallas, Texas, 75231

  • Urology Associates, P.C.

    Englewood, Colorado, 80113

  • Alliance Research

    Laguna Hills, California, 92653

  • Lincoln Urology, PC

    Lincoln, Nebraska, 68516

  • Tower Urology

    Los Angeles, California, 90048

  • Urology Cancer Center

    Omaha, Nebraska, 68130

  • Associated Urologist of North Carolina

    Raleigh, North Carolina, 27612

  • San Bernardino Urological

    San Bernardino, California, 92404

  • Skyline Urology

    Torrance, California, 90505

  • Chesapeake Urology Research Associates

    Towson, Maryland, 21204

  • Urology of Virginia

    Virginia Beach, Virginia, 23462

  • The Iowa Clinic

    West Des Moines, Iowa, 50266

  • Innovative Clinical Research Institute

    Whittier, California, 90603

  • Wichita Urology Group

    Wichita, Kansas, 67226

Other trials in United States

About this study

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

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

Read the detailed description

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

Conditions
Prostate Cancer
Being tested
Zytiga® (Abiraterone Acetate), SoluMatrix™ (Abiraterone Acetate)
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zytiga® (Abiraterone Acetate)Drug

    Also called Zytiga®

    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)Drug

    Also called SoluMatrix™

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

Study groups in NCT02737332
Study groupRoleWhat they receive
Zytiga® (Abiraterone Acetate)Active comparator1,000 MG (4 x 250 mg qd)
Receives: Drug: Zytiga® (Abiraterone Acetate)
SoluMatrix™ (Abiraterone Acetate)Experimental500 mg (4 x 125 mg qd)
Receives: Drug: SoluMatrix™ (Abiraterone Acetate)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Testosterone Levels

    Blood Sample tested for Serum Testosterone Levels

    Measured: Average of Day 9 and 10

Secondary outcomes (8)

  1. 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

    Measured: Day 28, Day 56, and Day 84

  2. 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.

    Measured: Day 28, Day 56, and Day 84

  3. Serum Testosterone Levels

    These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.

    Measured: Day 28, Day 56, and Day 84

  4. 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.

    Measured: Day 09, Day 28, Day 56, and Day 84

  5. AUC (0-inf)

    Steady state systemic exposure parameters

    Measured: 60 to 30 minutes prior to dosing and over 24 Hours post-dose

  6. 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).

    Measured: 60 to 30 minutes prior to dosing and over 24 Hours post-dose

  7. 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).

    Measured: 60 to 30 minutes prior to dosing and over 24 Hours post-dose

  8. 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).

    Measured: 60 to 30 minutes prior to dosing and over 24 Hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2016 (estimated)
  2. Study start21 Mar 2016
  3. Primary completion27 Feb 2017
  4. Study completion27 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02737332
Sponsor's protocol ID
CHL-AA-201
Acronym
STAAR
Status last verified
Nov 2021
First submitted
25 Mar 2016
Last updated
22 Nov 2021
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zytiga® (Abiraterone Acetate) and SoluMatrix™ (Abiraterone Acetate) in people with Prostate Cancer, run by Sun Pharmaceutical Industries Limited at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Testosterone Levels (time frame: Average of Day 9 and 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02737332.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.

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STAAR Clinical Trial NCT02737332 | AzTrials