Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Neoplasm Metastasis

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Neoplastic Processes

Anti-Inflammatory Agents

Antineoplastic Agents

All Drugs and Chemicals

Bone Density Conservation Agents

Prednisone

Denosumab

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Denosumab plus enzalutamide, abiraterone and prednisone

One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.

Enzalutamide

Abiraterone

This is a correlative study to characterize serum metabolites associated with bone deposition, growth and turnover in patients with newly diagnosed metastatic CRPC who are not currently receiving bone targeting agents.

Denosumab Plus Enzalutamide, Abiraterone and Prednisone Compared to Denosumab Plus Enzalutamide Alone for Men With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastases

Denosumab Plus Enzalutamide, Abiraterone and Prednisone Compared to Denosumab Plus Enzalutamide Alone for Men With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastases: Clinical Testing and Feasibility of a Serum-based Metabolomics Profile

University of Hawaii

adverse event collection performed by standard collection practices, medical chart review, disclosure from subject

Denosumab plus enzalutamide, abiraterone and prednisone

Denosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.

Enzalutamide: 160 mg enzalutamide by mouth daily

Abiraterone: 1000 mg abiraterone by mouth daily

Prednisone: 5 mg prednisone by mouth twice daily

Alliance A031201

Denosumab plus enzalutamide alone

Denosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.

Enzalutamide: 160 mg enzalutamide by mouth daily

Standard of Care

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Trial was terminated early due to low accrual of one subject. Data analysis not conducted due to the one enrolled subject not receiving all the treatment.

Stacy Mercado

Measure Change in Serum-based Metabolites Associated With Bone Deposition, Growth and Turnover in Patients Who Have CRPC With Clinical Evidence of Metastatic Disease to the Bone, All Using Gas Chromatography-time-of-flight Mass Spectrometry (GC-TOFMS).

Measure Time (Months) to Skeletal Related Event (SRE) of Patients on Therapy

Measure Time (Months) to Progression-free Survival of Patients on Therapy

Measure Time (Months) to Duration of Response of Patients on Therapy.

one subject enrolled and they discontinued early from trial, no analysis conducted

Measure Change in Technetium Bone Scintigraphy on Therapy Via Technetium Bone Scintigraphy or Sodium Fluoride (NaF) PET/CT Imaging

Measure Change in Treatment Response Via RECIST Criteria

Evaluate the Effect of Therapy on Quality of Life (QoL) in Patients Via QoL Questionnaire.

Evaluate the Effect of Therapy on Narcotic Use in Patients on Therapy Via Case Report Forms.

Overall Study

Spots Global Cancer Trial Database for Denosumab Plus Enzalutamide, Abiraterone and Prednisone Compared to Denosumab Plus Enzalutamide Alone for Men With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastases

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial