Enzalutamide With Ribociclib in Treating Patients With Metastatic Castrate-Resistant, Chemotherapy Naive Prostate Cancer That Retains Retinoblastoma Expression

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

December 1, 2015

Primary Completion Date

December 6, 2022

Study Completion Date

September 1, 2023

Conditions
Castration-Resistant Prostate CarcinomaMetastatic Prostate CarcinomaProstate Carcinoma Metastatic in the BoneStage IV Prostate Cancer AJCC v7
Interventions
DRUG

Enzalutamide

Given PO

DRUG

Ribociclib

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Pharmacological Study

Correlative studies

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Biopsy

Undergo tumor biopsy

PROCEDURE

Echocardiography

Undergo ECHO

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

PROCEDURE

Bone Scan

Undergo bone scan

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

Trial Locations (4)

10065

Memorial Sloan Kettering Cancer Center, New York

14263

Roswell Park Cancer Institute, Buffalo

19107

Thomas Jefferson University, Philadelphia

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

collaborator

Prostate Cancer Clinical Trials Consortium

OTHER

lead

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER