CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
Itraconazole +2 moredrug
Likely dose
Itraconazole orally (specific dose not stated in interventions or arms)AI-extracted
Key inclusion· 8
  • ✓Histologically confirmed prostate adenocarcinoma with biochemically relapsed disease (rising PSA on ≥2 successive measurements ≥2 weeks apart after prior definitive local therapy)
  • ✓Prior definitive local therapy (radical prostatectomy, external beam radiation, brachytherapy, or combination) with or without prior/salvage radiation
  • ✓No evidence of metastatic disease on bone scan and CT/MRI abdomen/pelvis within 6 weeks of study start
  • ✓Serum testosterone >150 ng/dL (single measurement if no prior ADT; two measurements >150 ng/dL at least 14 days apart, both within 3 months of study start if prior ADT)
Key exclusion· 8
  • ✕Castrate-resistant disease (rising PSA with testosterone <50 ng/dL or rising PSA within 3 months after last LHRH agonist/antagonist injection)
  • ✕Prior bilateral orchiectomy
  • ✕Congestive heart failure NYHA class III or higher
  • ✕History of chronic active hepatitis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01787331
NCT01787331Phase 2Completed
CompareCT.gov

Hedgehog Inhibition as a Non-Castrating Approach to Hormone Sensitive Prostate Cancer: A Phase II Study of Itraconazole in Biochemical Relapse

University of California, San Francisco·interventional·Posted Feb 8, 2013·Updated Feb 5, 2020

In Brief

A Phase 2 clinical trial evaluating Itraconazole, Laboratory Biomarker Analysis, and 1 other intervention for Prostate Adenocarcinoma and 4 related conditions. Completed, enrolled 21 participants across 1 site.

Detailed Summary

This phase II trial studies how well itraconazole works in treating patients with biochemically relapsed prostate cancer. Itraconazole may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Adenocarcinoma, Recurrent Prostate Carcinoma, Stage I Prostate Adenocarcinoma AJCC v7, Stage II Prostate Adenocarcinoma AJCC v7, Stage III Prostate Adenocarcinoma AJCC v7
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 8, 2013
Enrollment StartOct 29, 2013
Primary CompletionMay 30, 2017
Study CompletionSep 30, 2018
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 13.4 years ago

Interventions

Itraconazoledrug

Given PO

Laboratory Biomarker Analysisother

Correlative studies

Pharmacological Studyother

Correlative studies