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

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. According to ClinicalTrials.gov, the official US trial registry.

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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 finished NCT00309894 record still lists

NCT00309894 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (92% lower).

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 a single indexed study location in 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.

Similar trials for Prostate Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00309894's enrollment target sits among peer trials

49 490th of 735 higher than 241 of 735 other Prostate Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Prostate Cancer 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 NCT00309894, the US trial registry maintained by the National Library of Medicine. NCT00309894 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.