Evaluation of Response to Abiraterone/Prednisone by Race/Ethnicity and Other Factors in Metastatic Hormone Naive Prostate Cancer (APRE)
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|ClinicalTrials.gov Identifier: NCT03833921|
Recruitment Status : Not yet recruiting
First Posted : February 7, 2019
Last Update Posted : February 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Metastatic Prostate Cancer||Drug: Abiraterone Acetate Drug: Prednisone||Phase 2|
This is a single arm study in metastatic hormone naïve prostate cancer. Standard of care in these men is either to offer Androgen deprivation therapy (ADT) + abiraterone acetate/low-dose prednisone or, in men with higher tumor burden, to offer ADT + Docetaxel/prednisone. The investigator's experience is that even men with increased tumor burden often opt for abiraterone because of the improved side effect protocol as compared to chemotherapy.
Approximately 130 PSA response evaluable subjects will be enrolled, of which the investigators expect 50% to be African American based on clinic population and previous experience with clinical trial enrollment.
The study will enroll men with newly diagnosed hormone naïve prostate cancer within 42 days of receiving the first dose of ADT (LHRH agonist) or undergoing orchiectomy. Patients will continue ADT throughout the study. Abiraterone acetate and low dose prednisone will continue until progression as defined by standard PCWG2 criteria.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Response to Abiraterone/Prednisone by Race/Ethnicity, PSA Decline and Genetic Variation in Proteins Involved in Androgen Metabolism in Metastatic Hormone Naive Prostate Cancer|
|Estimated Study Start Date :||April 2019|
|Estimated Primary Completion Date :||November 2024|
|Estimated Study Completion Date :||April 2034|
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.
Drug: Abiraterone Acetate
1000 mg orally daily until disease progression
Other Name: Zytiga
5 mg oral low dose prednisone, twice daily
- PSA Response Rate [ Time Frame: Treatment start until 7 months after start of ADT ]The proportion of subjects with PSA levels less than 4 ng/ml at the given time point.
- Depth of PSA Response [ Time Frame: Treatment start until nadir, or up to 7 months after start of ADT if no nadir ]Measure of the absolute amount of change in PSA levels, or measure of proportional change in PSA levels.
- Frequency of Potentially Deleterious Polymorphisms [ Time Frame: Measured at baseline ]Number of potentially deleterious polymorphisms in proteins involved in androgen metabolism, stratified by race/ethnicity.
- Progression Free Survival [ Time Frame: Treatment start until event or up to 3 years after start of ADT ]Measure of time until disease progression.
- Time to PSA Progression [ Time Frame: Treatment start until event or up to 3 years after start of ADT ]Measure of time until PSA progression.
- Time to Subsequent Prostate Cancer Therapy [ Time Frame: Treatment start until event or up to 3 years after start of ADT ]Measure of time until start of subsequent prostate cancer therapy.
- Time to Initiation of Chemotherapy [ Time Frame: Treatment start until event or up to 3 years after start of ADT ]Measure of time until start of chemotherapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833921
|Contact: Martha Mims, MD, PhDfirstname.lastname@example.org|
|Contact: Carolyn Thibodeaux, BSemail@example.com|
|United States, Texas|
|Ben Taub General Hospital||Not yet recruiting|
|Houston, Texas, United States, 77030|
|Contact: Martha Mims, MD, PhD 713-798-7535 firstname.lastname@example.org|
|Contact: Carolyn Thibodeaux, BS 713-798-4797 email@example.com|
|Principal Investigator: Nicholas Mitsiades, MD, PhD|
|Dan L. Duncan Comprehensive Cancer Center at Baylor College of Medicine||Not yet recruiting|
|Houston, Texas, United States, 77030|
|Contact: Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor 713-798-1297 firstname.lastname@example.org|
|Principal Investigator:||Martha Mims, MD, PhD||Baylor College of Medicine|