Abiraterone Acetate, Prednisone, and Apalutamide in Treating Patients With Hormone-Naive Metastatic Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03821792|
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : August 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Prostate Carcinoma Prostate Adenocarcinoma Prostate Carcinoma Metastatic in the Bone Stage IV Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8||Drug: Abiraterone Acetate Drug: Apalutamide Drug: Prednisone||Phase 2|
I. Determine if a baseline molecular-pathologic androgen receptor response (AR-response) signature predicts efficacy to abiraterone plus apalutamide in patients with hormone-naive metastatic prostate cancer (HNMPCa).
I. Evaluate the efficacy of abiraterone acetate plus apalutamide in patients with HNMPCa.
II. Evaluate the safety of abiraterone acetate plus apalutamide in patients with HNMPCa.
III. Explore the relationship between molecular markers and clinical efficacy outcomes.
Patient receive abiraterone acetate orally (PO) daily, prednisone PO twice daily (BID), and apalutamide PO daily. Cycles repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then for up to 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Course Determining Study for Men With Hormone-Naïve Metastatic Prostate Cancer (HNMPCa)|
|Actual Study Start Date :||July 22, 2019|
|Estimated Primary Completion Date :||October 1, 2022|
|Estimated Study Completion Date :||October 1, 2023|
Experimental: Treatment (abiraterone acetate, prednisone, apalutamide)
Patient receive abiraterone acetate PO daily, prednisone PO BID, and apalutamide PO daily. Cycles repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity.
Drug: Abiraterone Acetate
- Time on treatment [ Time Frame: Up to 6 months ]Calculated as the time from start of protocol treatment
- Progression free survival (PFS) [ Time Frame: Time from starting treatment until progression, assessed up to 6 months ]Median PFS and 95% confidence interval will be presented for all patients and by the androgen receptor molecular-pathologic responsiveness signature.
- Incidence of adverse events [ Time Frame: Up to 6 months ]Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
- Efficacy assessed [ Time Frame: Up to 6 months ]prostate specific antigen, bone specific alkaline phosphatase, and urine n-telopeptides
- Expression of candidate markers [ Time Frame: Up to 6 months ]Candidate markers for different biologic domains by immunohistochemistry, mass spectrometry (for steroid metabolome) and genomic profiling. Markers will encompass bone remodeling (e.g. integrin signaling), steroid metabolome (e.g. glucocorticoid receptor) and tumor immunoprofile (e.g. PD-1, PDL-1).
- Overall survival [ Time Frame: up to 6 months ]Time from start of protocol treatment until death or last contact
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): NCT03821792
|Contact: Paul Cornfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Paul Corn 713-792-2830|
|Principal Investigator: Paul Corn|
|Principal Investigator:||Paul Corn||M.D. Anderson Cancer Center|