CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
Ibrance +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02059213
NCT02059213Phase 2Completed
CompareCT.gov

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

University of Michigan Rogel Cancer Center·interventional·Posted Feb 11, 2014·Updated Sep 16, 2020

In Brief

A Phase 2 clinical trial evaluating Ibrance, Bicalutamide, and 2 other interventions for Prostate Cancer. Completed, enrolled 72 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsUniversity of Utah, Vanderbilt-Ingram Cancer Center, Johns Hopkins University, Thomas Jefferson University, Washington University School of Medicine, Northwestern University, City of Hope Medical Center

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 11, 2014
Enrollment StartJun 1, 2014
Primary CompletionSep 9, 2017
Study CompletionJun 4, 2019
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 12.4 years ago

Interventions

Ibrancedrug

Bicalutamidedrug

Zoladexdrug

Lupron Depotdrug