NCT00002760 is a Phase 3 clinical trial of ketoconazole in Prostate Cancer, sponsored by Alliance for Clinical Trials in Oncology.

Who is sponsoring NCT00002760?

NCT00002760 is sponsored by Alliance for Clinical Trials in Oncology.

What drugs are being tested in NCT00002760?

Interventions in NCT00002760: ketoconazole, therapeutic hydrocortisone, Withdrawal of antiandrogen therapy.

What condition does NCT00002760 study?

NCT00002760 studies Prostate Cancer.

Is NCT00002760 still recruiting?

NCT00002760 is currently completed. Last updated 27 June 2016.

Last reviewed 2016-06-27 · How we verify

NCT00002760

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A PHASE III TWO-ARM RANDOMIZED STUDY COMPARING ANTIANDROGEN WITHDRAWAL ALONE VERSUS ANTIANDROGEN WITHDRAWAL COMBINED WITH KETOCONAZOLE AND HYDROCORTISON IN PATIENTS WITH ADVANCED PROSTAGE CANCER

Completed Phase 3 Last updated 27 June 2016

What this trial tests

Phase 3 trial testing ketoconazole in Prostate Cancer in 260 participants. Completed in 1 April 2009.

Timeline

1 August 1996

Primary endpoint
1 March 2004

1 April 2009

Quick facts

Lead sponsor	Alliance for Clinical Trials in Oncology
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	260
Start date	1 August 1996
Primary completion	1 March 2004
Estimated completion	1 April 2009
Sites	2 locations across United States

Drugs / interventions tested

ketoconazole (ketoconazole) — full drug profile →
therapeutic hydrocortisone — full drug profile →
Withdrawal of antiandrogen therapy

Conditions studied

Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Alliance for Clinical Trials in Oncology

Who can join

Under 120, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Response: PSA
Time frame: q 8 wks, at cross over (if applicable), at progression; q 6 mon in f/u

Sponsor's own description

RATIONALE: Antiandrogen withdrawal may be an effective treatment for prostate cancer. PURPOSE: Randomized phase III trial to study the effectiveness of ketoconazole and hydrocortisone for antiandrogen withdrawal in treating men with prostate cancer that is refractory to hormone therapy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of ketoconazole

Trials testing the same drug.

NCT01802931 — GSK239512 DDI Study · Phase 1 · completed
NCT01165125 — A Drug Interaction Study With Fluticasone Furoate/GW642444 Inhalation Powder and Ketoconazole · Phase 1 · completed
NCT00953576 — Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer · Phase 1, PHASE2 · terminated
NCT00404378 — Study Of Healthy Subjects To Assess The Effect Of Ketoconazole And The Way The Body Will React To Casopitant [GW679769] · Phase 1 · completed
NCT00460031 — Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy · Phase 2 · completed

Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

NCT06960798 — Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno) · recruiting
NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting
NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting

Other Alliance for Clinical Trials in Oncology trials

Trials by the same sponsor.

NCT07293247 — A Study of Targeted Post-Surgery Radiation Therapy for Non-Small Cell Lung Cancer With Remaining Lymph Node Cancer After · Phase 2 · not yet recruiting
NCT07283939 — Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays · NA · recruiting
NCT07059884 — Distance-Based Exercise to Preserve Function and Prevent Disability · NA · recruiting
NCT07321652 — Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated C · Phase 3 · not yet recruiting
NCT07091617 — Testing an Enhanced Digital Delivery Model for Inherited Cancer Genetic Testing in Young Adults With Cancer · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00002760 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology
Last refreshed: 27 June 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00002760.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing