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NCT00309894 · ClinicalTrials.gov registry record · Phase 2

Ketoconazole, Hydrocortisone, and GM-CSF in Treating Patients With Progressive Prostate Cancer After Hormone Therapy

A Phase 2 study of Prostate Cancer, sponsored by University of California, San Francisco.

Completed
Registry status
Phase 2
Development phase
49
Enrollment target
2
Study locations

NCT00309894 is a Phase 2 study of Prostate Cancer that has completed, run by University of California, San Francisco. The registered enrollment target is 49 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT00309894, a Phase 2 study of Prostate Cancer, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
Phase 2
Development phase
49 participants
Enrollment target
2
Study locations

Study Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as ketoconazole, may stop the adrenal glands from making androgens. GM-CSF may help ketoconazole work better by making tumor cells more sensitive to the drug. Giving ketoconazole together with hydrocortisone and GM-CSF may be an effective treatment for prostate cancer. PURPOSE: This phase II trial is studying how well giving ketoconazole together with hydrocortisone and GM-CSF works in treating patients with progressive prostate cancer after hormone therapy.

Conditions Studied

Interventions

  • BIOLOGICAL sargramostim
  • DRUG ketoconazole
  • DRUG therapeutic hydrocortisone

Study Locations (2)

California

  • UCSF Comprehensive Cancer Center - San Francisco
  • Veterans Affairs Medical Center - San Francisco - San Francisco

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2004-04
Est. Completion 2007-12
Phase Phase 2

What the Registry Record Tells You About NCT00309894

The ClinicalTrials.gov registry entry for NCT00309894 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (92% lower). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which sargramostim is the first listed.

NCT00309894 reports 2 study locations spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT00309894 about?

NCT00309894 is a clinical study titled "Ketoconazole, Hydrocortisone, and GM-CSF in Treating Patients With Progressive Prostate Cancer After Hormone Therapy". RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as ketoconazole, may stop the adrenal glands from making androgens. GM-CSF may help ketoconazole work better by making tumor cells more sensitive to the drug. Giving ketoconazole together with hydrocortisone and GM-CSF m...

What is the current status of trial NCT00309894?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2004-04. Estimated completion is 2007-12.

What conditions does trial NCT00309894 study?

This clinical trial studies the following conditions: Prostate Cancer.

What interventions are being tested in trial NCT00309894?

The interventions under investigation include: sargramostim (BIOLOGICAL), ketoconazole (DRUG), therapeutic hydrocortisone (DRUG).

Who is sponsoring clinical trial NCT00309894?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00309894 being conducted?

This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.