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NCT02059213 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.

Completed
Registry status
Phase 2
Development phase
72
Enrollment target

NCT02059213: Completed Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.

NCT02059213 is a Phase 2 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 72 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02059213, a Phase 2 study, has completed, sponsored by University of Michigan Rogel Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
72 participants
Enrollment target

Study 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.

Primary Outcome

The primary analysis will be assessment of the proportion of patients who achieve a (Prostate-specific antigen) PSA \< 4ng/mL after seven months of protocol treatment in each arm.

Interventions

  • DRUG Bicalutamide
  • DRUG Zoladex
  • DRUG Ibrance
  • DRUG Lupron Depot

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2014-06
Est. Completion 2019-06-04
Phase Phase 2

What the finished NCT02059213 record still lists

NCT02059213 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower).

The record links to 0 conditions, and to 4 interventions - of which Bicalutamide is the first listed.

NCT02059213 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02059213 about?

NCT02059213 is a clinical study titled "A Phase II Study of Androgen Deprivation Therapy With or Without Palbociclib in RB-Positive Metastatic Prostate Cancer". 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 Deprivati...

What is the current status of trial NCT02059213?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2014-06. Estimated completion is 2019-06-04.

What interventions are being tested in trial NCT02059213?

The interventions under investigation include: Bicalutamide (DRUG), Zoladex (DRUG), Ibrance (DRUG), Lupron Depot (DRUG).

Who is sponsoring clinical trial NCT02059213?

This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02059213's enrollment target sits among peer trials

72 925th of 2000 higher than 1,065 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02059213, the US trial registry maintained by the National Library of Medicine. NCT02059213 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.