Study of Itraconazole in Castrate-resistant Prostate Cancer (CRPC) Post-chemotherapy

Phase 2

Terminated

• Conditions: Castrate-resistant Prostate Cancer (CRPC); Prostatic Neoplasms; Androgen-insensitive Prostate Cancer; Hormone-refractory Prostate Cancer; Prostate Cancer; Metastatic Disease
• Interventions: Drug: Itraconazole

• Registration Number: NCT01450683
• Lead Sponsor: Stanford University

Brief Summary

This study evaluates if itraconazole causes a reduction in the serum levels of prostate-specific antigen (PSA) in male subjects with castration-resistant prostate cancer (CRPC).

Detailed Description

Castration-resistant prostate cancer (CRPC) is also known as "androgen-insensitive" or "hormone-refractory" prostate cancer. While numerous therapies impact biochemical response in the setting of CRPC, there remains unmet medical need, largely expressed as the lack of durable response. New therapies that extend survival of patients beyond that provided by chemotherapy are needed.

It is hypothesized that the triazole antifungal drug itraconazole, through its activity as a potent inhibitor of the Hedgehog (Hh) signaling pathway via the Smoothened (Smo) pathway, may provide clinical benefit in the treatment of prostate cancer. The Hh signaling pathway is a critical embryonic developmental pathway whose aberrant activity has been implicated in the growth and metastases of a variety of tumor types including prostate cancer. Itraconazole is structurally related to ketoconazole, demonstrated to reduce serum PSA by more than 50% in about 20 to 25% of treated prostate cancer subjects.

This study will assess efficacy on the basis of serum levels of PSA, an established surrogate endpoint for efficacy in prostate cancer.

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Study First Submitted: 2011-09-30
• Study First Submitted QC: 2011-10-07
• Study First Posted: 2011-10-12
• Results First Submitted: 2014-08-29
• Results First Submitted QC: 2014-08-29
• Results First Posted: 2014-09-08
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Itraconazole	Itraconazole	600 mg/day oral (PO)

Primary Outcome Measures

Name	Time	Method
Reduction in Serum PSA	12 weeks treatment, with primary outcome assessed at 15 weeks	Number of subjects with \> 50% drop in serum PSA as compared to baseline, at 12 weeks and confirmed at 15 weeks

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States