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Report for Clinical Trial NCT02125357

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Randomized Phase II Study of Sequencing Abiraterone Acetate and Enzalutamide in Metastatic Castration-Resistant Prostate Cancer

This study is being offered to patients who have castrate-resistant (also known as hormone-refractory) prostate cancer. The cancer has metastasized or spread outside the prostate area to other parts of the body. The purpose of this study is to evaluate the effects of sequencing hormonal therapies (abiraterone acetate and enzalutamide) and to assess treatment efficacy of these two agents.

NCT02125357 Metastatic Castration-Resistant Prostate Cancer
MeSH:Prostatic Neoplasms
HPO:Prostate cancer Prostate neoplasm

2 Interventions

Name: Abiraterone acetate

Description: Abiraterone acetate 1000mg PO OD with prednisone 5mg PO BID or 10mg OD as per standard of care.
Type: Drug
Group Labels: 1

A - Abiraterone Acetate

Name: Enzalutamide

Description: 160mg PO OD as per standard of care.
Type: Drug
Group Labels: 1

B - Enzalutamide

Primary Outcomes

Measure: PSA response rate in mCRPC patients with PSA progression on first-line therapy when crossed over to second-line therapy with the opposite agent

Time: 1 year

Secondary Outcomes

Description: Among mCRPC patients receiving abiraterone acetate and enzalutamide

Measure: Potential biomarkers that are associated with treatment efficacy and/ or resistance

Time: 1 year

Other Outcomes

Measure: PSA response rate in mCRPC patients treated with first-line abiraterone acetate or enzalutamide

Time: 1 year

Purpose: Other

Allocation: Randomized

Crossover Assignment

There is one SNP


1 F876L

In pre-clinical studies, other potential mechanisms of resistance to these agents include increased expression of AR splice variants (abiraterone and enzalutamide) increased expression of CYP17 (abiraterone), upregulation of the stress-activated chaperone protein clusterin (enzalutamide only) and a point mutation (F876L) in the ligand-binding domain of the AR (enzalutamide only). --- F876L ---

HPO Nodes