Oral Calcitriol With Ketoconazole in CRPC

• ClinicalTrials.gov Identifier: NCT03261336
• Recruitment Status: Terminated
• First Posted: August 25, 2017
• Results First Posted: February 8, 2021
• Last Update Posted: February 8, 2021
• Sponsor: Donald Trump, MD
• Information provided by (Responsible Party): Donald Trump, MD, Inova Health Care Services

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Castration-resistant Prostate Cancer
• Intervention: Drug: Calcitriol, Ketoconazole, Hydrocortisone
• Enrollment: 1

Participant Flow

Recruitment Details	Study was closed at site in 2018 due to enrollment challenges. Only 1 patient was enrolled to trial. No evaluable results.
Pre-assignment Details

Arm/Group Title	Calcitriol, Ketoconazole, Hydrocortisone
Arm/Group Description	Patients receive calcitriol (10mcg QD X3 weekly) in addition to ketoconazole (400mg QD) and hydrocortisone (20mg AM, 10 mg PM). Calcitriol, Ketoconazole, Hydrocortisone: Calcitriol (0.5 mcg caplets) given in escalating doses, orally QD X3 consecutive days every week Ketoconazole, 200 mg tablets, 2 tablets orally TID Hydrocortisone 20mg AM, 10mg PM orally starting in the evening before the first dose of Calcitriol
Period Title: Overall Study
Started	1
Completed	0
Not Completed	1
Reason Not Completed
Adverse Event	1

Baseline Characteristics

Arm/Group Title		Calcitriol, Ketoconazole, Hydrocortisone
Arm/Group Description		Patients receive calcitriol (10mcg QD X3 weekly) in addition to ketoconazole (400mg QD) and hydrocortisone (20mg AM, 10 mg PM). Calcitriol, Ketoconazole, Hydrocortisone: Calcitriol (0.5 mcg caplets) given in escalating doses, orally QD X3 consecutive days every week Ketoconazole, 200 mg tablets, 2 tablets orally TID Hydrocortisone 20mg AM, 10mg PM orally starting in the evening before the first dose of Calcitriol
Overall Number of Baseline Participants		1
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	0 0.0%
	>=65 years	1 100.0%
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	1 participants
		78; (78 to 78)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1 participants
	Female	0 0.0%
	Male	1 100.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1 participants
	American Indian or Alaska Native	0 0.0%
	Asian	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	0 0.0%
	White	1 100.0%
	More than one race	0 0.0%
	Unknown or Not Reported	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	1 participants
		1

Outcome Measures

1. Primary Outcome

Title	PSA Response Rate
Description	Assessment of PSA every 4 weeks
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Only one patient enrolled to study and was discontinued early due to AE.

Arm/Group Title	Calcitriol, Ketoconazole, Hydrocortisone
Arm/Group Description:	Patients receive calcitriol (10mcg QD X3 weekly) in addition to ketoconazole (400mg QD) and hydrocortisone (20mg AM, 10 mg PM). Calcitriol, Ketoconazole, Hydrocortisone: Calcitriol (0.5 mcg caplets) given in escalating doses, orally QD X3 consecutive days every week Ketoconazole, 200 mg tablets, 2 tablets orally TID Hydrocortisone 20mg AM, 10mg PM orally starting in the evening before the first dose of Calcitriol
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

2. Secondary Outcome

Title	Tumor Response
Description	Objective tumor response among patients with measurable disease using modified RECIST1.1
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Only one patient was enrolled and was discontinued due to AE.

Arm/Group Title	Calcitriol, Ketoconazole, Hydrocortisone
Arm/Group Description:	Patients receive calcitriol (10mcg QD X3 weekly) in addition to ketoconazole (400mg QD) and hydrocortisone (20mg AM, 10 mg PM). Calcitriol, Ketoconazole, Hydrocortisone: Calcitriol (0.5 mcg caplets) given in escalating doses, orally QD X3 consecutive days every week Ketoconazole, 200 mg tablets, 2 tablets orally TID Hydrocortisone 20mg AM, 10mg PM orally starting in the evening before the first dose of Calcitriol
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

3. Secondary Outcome

Title	Toxicity and Tolerability of Experimental Arm
Description	Descriptive analysis of observed toxicity and patient reports of tolerating experimental treatment
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Patient developed hypercalcemia and was discontinued from study. AE is known, not unexpected.

Arm/Group Title	Calcitriol, Ketoconazole, Hydrocortisone
Arm/Group Description:	Patients receive calcitriol (10mcg QD X3 weekly) in addition to ketoconazole (400mg QD) and hydrocortisone (20mg AM, 10 mg PM). Calcitriol, Ketoconazole, Hydrocortisone: Calcitriol (0.5 mcg caplets) given in escalating doses, orally QD X3 consecutive days every week Ketoconazole, 200 mg tablets, 2 tablets orally TID Hydrocortisone 20mg AM, 10mg PM orally starting in the evening before the first dose of Calcitriol
Overall Number of Participants Analyzed	1
Measure Type: Count of Participants; Unit of Measure: Participants
	1 100.0%

Adverse Events

Time Frame	AE data was collected on a single patient during one month in 2017.
Adverse Event Reporting Description	Definition consistent with clinicaltrials.gov
Arm/Group Title	Calcitriol, Ketoconazole, Hydrocortisone
Arm/Group Description	Patients receive calcitriol (10mcg QD X3 weekly) in addition to ketoconazole (400mg QD) and hydrocortisone (20mg AM, 10 mg PM). Calcitriol, Ketoconazole, Hydrocortisone: Calcitriol (0.5 mcg caplets) given in escalating doses, orally QD X3 consecutive days every week Ketoconazole, 200 mg tablets, 2 tablets orally TID Hydrocortisone 20mg AM, 10mg PM orally starting in the evening before the first dose of Calcitriol
All-Cause Mortality
	Calcitriol, Ketoconazole, Hydrocortisone
	Affected / at Risk (%)
Total	0/1 (0.00%)
Serious Adverse Events
	Calcitriol, Ketoconazole, Hydrocortisone
	Affected / at Risk (%)	# Events
Total	1/1 (100.00%)
Blood and lymphatic system disorders
hypercalcemia *	1/1 (100.00%)	1
* Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Calcitriol, Ketoconazole, Hydrocortisone
	Affected / at Risk (%)	# Events
Total	0/1 (0.00%)

Limitations and Caveats

Study was closed due to inability to accrue. One patient was entered on study and did develop hypercalcemia which led to treatment discontinuation. Insufficient time on study to evaluate response.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Stephanie Van Bebber, Sr. Director Clinical Trials
• Organization: Inova Schar Cancer Institute
• Phone: 5714720213
• EMail: Stephanie.VanBebber@inova.org

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• Responsible Party: Donald Trump, MD, Inova Health Care Services
• ClinicalTrials.gov Identifier: NCT03261336
• Other Study ID Numbers: 16-2200
• First Submitted: July 12, 2017
• First Posted: August 25, 2017
• Results First Submitted: January 19, 2021
• Results First Posted: February 8, 2021
• Last Update Posted: February 8, 2021