Oral Calcitriol With Ketoconazole in CRPC

Phase 2

Terminated

• Conditions: Castration-resistant Prostate Cancer
• Interventions: Drug: Calcitriol, Ketoconazole, Hydrocortisone

• Registration Number: NCT03261336
• Lead Sponsor: Donald Trump, MD

Brief Summary

The aim of this study is to estimate the PSA response rate with the use of ketoconazole (400mg QD + hydrocortisone 20mg AM, 10 mg PM) among men with CRPC in whom disease has progressed despite abiraterone

Detailed Description

This study will aim to describe objective tumor responses to the combination of oral calcitriol and ketoconazole and hydrocortisone-among patients with measurable disease using modified RECIST 1.1 criteria.

Additionally, we will determine toxicities, and tolerability of oral calcitriol combination with daily oral ketoconazole, and hydrocortisone in this patient population.

this is a single arm phase II trial of ketoconazole (400mg QD + hydrocortisone 20mg AM, 10 mg PM) among men with CRPC in whom disease has progressed despite abiraterone

Study Timeline

• Study Start: 2017-01-06
• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-08-23
• Study First Posted: 2017-08-25
• Primary Completion: 2018-02-28
• Study Completion: 2018-02-28
• Status Verified: 2021-01
• Results First Submitted: 2021-01-19
• Results First Submitted QC: 2021-01-19
• Last Update Submitted: 2021-01-19
• Results First Posted: 2021-02-08
• Last Update Posted: 2021-02-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Calcitriol, Ketoconazole, Hydrocortisone	Calcitriol, Ketoconazole, Hydrocortisone	Patients receive calcitriol (10mcg QD X3 weekly) in addition to ketoconazole (400mg QD) and hydrocortisone (20mg AM, 10 mg PM).

Primary Outcome Measures

Name	Time	Method
PSA Response Rate	2 years	Assessment of PSA every 4 weeks

Secondary Outcome Measures

Name	Time	Method
Tumor Response	2 years	Objective tumor response among patients with measurable disease using modified RECIST1.1
Toxicity and Tolerability of Experimental Arm	2 years	Descriptive analysis of observed toxicity and patient reports of tolerating experimental treatment

Trial Locations

Locations (1)

Inova Schar Cancer Institute; 🇺🇸 Fairfax, Virginia, United States