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A Phase II Study of Androgen Deprivation Therapy With or Without Palbociclib in RB-Positive Metastatic Prostate Cancer

NCT02059213 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2020-09-16

Study results available
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Summary

This study will look at the effect of adding the drug Palbociclib to CAD (Combined Androgen Deprivation) therapy in patients with RB (Retinoblastoma Protein) positive hormone sensitive prostate cancer.

The investigators hypothesize that the addition of Palbociclib to initial ADT (Androgen Deprivation Therapy) in patients with newly metastatic RB-positive prostate cancer may significantly increase the efficacy of ADT.

Conditions

Interventions

DRUG

Ibrance

DRUG

Bicalutamide

DRUG

Zoladex

DRUG

Lupron Depot

Sponsors & Collaborators

  • University of Utah

    collaborator OTHER

  • Vanderbilt-Ingram Cancer Center

    collaborator OTHER

  • Johns Hopkins University

    collaborator OTHER

  • Thomas Jefferson University

    collaborator OTHER

  • Washington University School of Medicine

    collaborator OTHER

  • Northwestern University

    collaborator OTHER

  • City of Hope Comprehensive Cancer Center

    collaborator OTHER

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Maha Hussain, MD, FACP, FASCO · University of Michigan Comprehensive Cancer Center and Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2017-09-09
Completion
2019-06-04

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02059213 on ClinicalTrials.gov