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NCT00814788 · ClinicalTrials.gov registry record · Phase 2

Bicalutamide With or Without Everolimus in Treating Patients With Recurrent or Metastatic Prostate Cancer

A Phase 2 study, sponsored by University of California, Davis.

Completed
Registry status
Phase 2
Development phase
24
Enrollment target

NCT00814788: Completed Phase 2 study, sponsored by University of California, Davis.

NCT00814788 is a Phase 2 study that has completed, run by University of California, Davis. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00814788, a Phase 2 study, has completed, sponsored by University of California, Davis.

COMPLETED
Registry status
Phase 2
Development phase
24 participants
Enrollment target

Study Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying bicalutamide and everolimus to see how well they work compared with bicalutamide in treating patients with recurrent or metastatic prostate cancer.

Primary Outcome

The PSA response rate was defined as a 30% reduction in the PSA level from baseline. PSA Working Group consensus criteria combined with radiographic studies were used to determine the proportion of patients with PSA decline.

Interventions

  • DRUG Everolimus
  • DRUG Bicalutamide

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2008-12
Est. Completion 2016-01
Phase Phase 2
University of California, Davis

657 total trials

What the finished NCT00814788 record still lists

NCT00814788 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).

The record links to 0 conditions, and to 2 interventions - of which Everolimus is the first listed.

NCT00814788 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00814788 about?

NCT00814788 is a clinical study titled "Bicalutamide With or Without Everolimus in Treating Patients With Recurrent or Metastatic Prostate Cancer". RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is s...

What is the current status of trial NCT00814788?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2008-12. Estimated completion is 2016-01.

What interventions are being tested in trial NCT00814788?

The interventions under investigation include: Everolimus (DRUG), Bicalutamide (DRUG).

Who is sponsoring clinical trial NCT00814788?

This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00814788's enrollment target sits among peer trials

24 1756th of 2000 higher than 217 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 NCT00814788, the US trial registry maintained by the National Library of Medicine. NCT00814788 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.