Evaluation of Response to Abiraterone/Prednisone by Race/Ethnicity and Other Factors in Metastatic Hormone Naive Prostate Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
Martha Mims
Study ID
NCT03833921
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abiraterone Acetate — DRUG
    1000 mg orally daily until disease progression
  • Prednisone — DRUG
    5 mg oral low dose prednisone, twice daily

Study Details

The investigators are conducting this study with men that have prostate cancer and are getting standard of care treatment with the drugs abiraterone acetate and prednisone. The study will follow men with prostate cancer from initiation of participation in the study and for up to 10 years. The reason for the study is that researchers think that there may be a connection between the race and ethnicity of men with prostate cancer and how well the standard treatments work for the participants.

Key Dates

Start date
May 23, 2019
Status verified
Dec 2025
Primary completion
Nov 30, 2028
Completion
Apr 30, 2038

Study Design

Enrollment
130 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Abiraterone acetate + prednisone
    All subjects will receive abiraterone acetate and prednisone, as per standard of care. Abiraterone acetate will be administered orally as 1000 mg once daily along with 5 mg of oral prednisone twice per day. Subjects will continue to take abiraterone acetate and prednisone until confirmed disease progression.

Primary Outcome Measure

PSA Response Rate [ Time Frame: Treatment start until 7 months after start of ADT ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Ben Taub General HospitalHoustonTexas77030
Martha Mims, MD, PhD
[email protected]
713-798-7535
Carolyn Thibodeaux, BS
[email protected]
713-798-4797
Martha Mims, MD, PhD (PRINCIPAL_INVESTIGATOR)
Dan L. Duncan Comprehensive Cancer Center at Baylor College of MedicineHoustonTexas77030
Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor
[email protected]
713-798-1297
Michael E. DeBakey Veterans Affairs Medical CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Ben Taub General Hospital· Houston, TXDan L. Duncan Comprehensive Cancer Center at Baylor College of Medicine· Houston, TXMichael E. DeBakey Veterans Affairs Medical Center· Houston, TX

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