Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer

• Sponsor: University of Chicago (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00515112
• Collaborator: Solvay Pharmaceuticals (Industry)
• Enrollment: 6
• Locations: 11
• Arms: 2
• Duration (Months): 61
• Patients Per Site: 0.5
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether prostate cancer growth can be slowed in patients who receive Androgel® 1% at 10 gram dose.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: AndroGel; Drug: placebo	Phase 2

Detailed Description

The primary objective of the study is to determine the effect of testosterone replacement on time to disease progression and time to clinical cancer progression.

The secondary objectives are to describe the effect of testosterone replacement on patient-reported quality of life (FACT-P, FACT-fatigue and specific measures from the Expanded Prostate Cancer Index (EPIC): Sexual and Hormonal Assessments), and hand-grip strength; to describe changes in total testosterone, free testosterone, and PSA levels; to explore AR levels in circulating tumor cells as a marker of treatment benefit.

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double Blind, Placebo-Controlled Phase II Study of Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer
• Study Start Date: Jul 1, 2007
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Twenty subjects will receive testosterone gel	Drug: AndroGel; Androgel 1%, 10g daily
Placebo Comparator: B Twenty subjects will receive the placebo	Drug: placebo; placebo

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival [Up to 5 years]

   Time to progression is measured from the date of randomization until the onset of the earliest of one of the following events: in the absence of a 50% decline in prostate-specific antigen (PSA), a PSA increase to 3 times the nadir PSA or an absolute PSA value of 50 ng/ml, whichever comes first; if at least a 50% decline in PSA is achieved from PSA peak value, a PSA increase of 50% above the nadir provided the increase is at least 5 ng/ml or back to baseline; one or more new skeletal lesions as shown on any bone scan or minimum of 1.5 cm in longest diameter on any computed tomography or magnetic resonance imaging scan; tumor flair; the occurrence of a clinical event, including death, determined by the investigator to represent disease progression.

Secondary Outcome Measures

1. To Explore the Value of Androgen Receptor (AR) Expression in Circulating Tumor Cells. [every 8 weeks]

   The AR is defined as 4 categories by the observed data: no detectable cells, low AR expression, normal AR expression, and high AR expression.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Prostate cancer

• Patient must have received primary definitive local therapy to the prostate (surgery and/or radiotherapy)

• Patient was surgically or pharmacologically castrated at least 6 months prior to starting the study

• Patient must have had a previous trial of anti-androgen therapy

• Patient must have a rising PSA

• No evidence of distant metastatic disease

• ECOG performance status < 2

• Age >18 years

• Patients must have normal hepatic function

Exclusion Criteria:

• Patients with a history of any previous cytotoxic therapy or radionuclide therapy (such as rhenium, strontium, or samarium)

• Patients may not be receiving any other investigational agents

• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Patients receiving renal dialysis

• Patients with significant pulmonary disease who have received chronic or pulse steroid therapy within the last 3 months prior to randomization will be excluded

• Patients who have known hypersensitivity to any of the AndroGel ingredients, including testosterone that is chemically synthesized from soy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Southern California	Los Angeles	California	United States	90033
2	University of Colorado	Aurora	Colorado	United States	80045
3	Northwestern University	Chicago	Illinois	United States	60610
4	University of Chicago	Chicago	Illinois	United States	60637
5	NorthShore University Helath System	Evnaston	Illinois	United States	60201
6	Ingalls Memorial Hospital	Harvey	Illinois	United States	60426
7	Illinois Cancer Care	Peoria	Illinois	United States	61656
8	University of Maryland	Baltimore	Maryland	United States	21202
9	University of Rochester	Rochester	Maryland	United States	14642
10	Baylor College of Medicine	Houston	Texas	United States	77030
11	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

• University of Chicago
• Solvay Pharmaceuticals

Investigators

• Principal Investigator: Walter Stadler, MD, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT00515112
• Other Study ID Numbers: 15393B
• First Posted: Aug 13, 2007
• Last Update Posted: Jun 11, 2014
• Last Verified: May 1, 2014

• Keywords provided by University of Chicago: prostate; cancer; testosterone replacement; AndroGel; prostatic cancer; prostatic neoplasms
• Additional relevant MeSH terms: Prostatic Neoplasms; Testosterone

Study Results

Participant Flow

Arm/Group Title	Androgel	Placebo
Arm/Group Description	Three subjects received testosterone gel AndroGel: Androgel 1%, 10g daily	Three subjects received the placebo Placebo: placebo
Period Title: Overall Study
STARTED	3	3
COMPLETED	0	0
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	Androgel	Placebo	Total
Arm/Group Description	Three subjects received testosterone gel AndroGel: Androgel 1%, 10g daily	Three subjects received the placebo Placebo: placebo	Total of all reporting groups
Overall Participants	3	3	6
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.4 (4.6)	63.5 (8.6)	66.4 (7.0)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	3 100%	3 100%	6 100%

Outcome Measures

1. Primary Outcome

Title	Progression Free Survival
Description	Time to progression is measured from the date of randomization until the onset of the earliest of one of the following events: in the absence of a 50% decline in prostate-specific antigen (PSA), a PSA increase to 3 times the nadir PSA or an absolute PSA value of 50 ng/ml, whichever comes first; if at least a 50% decline in PSA is achieved from PSA peak value, a PSA increase of 50% above the nadir provided the increase is at least 5 ng/ml or back to baseline; one or more new skeletal lesions as shown on any bone scan or minimum of 1.5 cm in longest diameter on any computed tomography or magnetic resonance imaging scan; tumor flair; the occurrence of a clinical event, including death, determined by the investigator to represent disease progression.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

This study has been terminated due to poor accrual.

Arm/Group Title	Androgel	Placebo
Arm/Group Description	Three subjects received testosterone gel AndroGel: Androgel 1%, 10g daily	Three subjects received the placebo Placebo: placebo
Measure Participants	0	0

2. Secondary Outcome

Title	To Explore the Value of Androgen Receptor (AR) Expression in Circulating Tumor Cells.
Description	The AR is defined as 4 categories by the observed data: no detectable cells, low AR expression, normal AR expression, and high AR expression.
Time Frame	every 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Androgel	Placebo
Arm/Group Description	Three subjects received testosterone gel AndroGel: Androgel 1%, 10g daily	Three subjects received the placebo Placebo: placebo
Measure Participants	0	0

Adverse Events

Arm/Group Title	Androgel		Placebo
Arm/Group Description	Three subjects received testosterone gel AndroGel: Androgel 1%, 10g daily		Three subjects received the placebo Placebo: placebo
All Cause Mortality
	Androgel		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Androgel		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Androgel		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100%)		3/3 (100%)
Gastrointestinal disorders
Abdominal pain	0/3 (0%)		1/3 (33.3%)
Diarrhea	1/3 (33.3%)		0/3 (0%)
Dark stools	0/3 (0%)		1/3 (33.3%)
Nausea	1/3 (33.3%)		0/3 (0%)
Vomiting	1/3 (33.3%)		0/3 (0%)
General disorders
Fatigue	1/3 (33.3%)		1/3 (33.3%)
Pain- other: shoulder and back pain	0/3 (0%)		1/3 (33.3%)
Investigations
Alkaline phosphatase increased	0/3 (0%)		1/3 (33.3%)
Blood bicarbonate decreased	1/3 (33.3%)		0/3 (0%)
Hemoglobin	2/3 (66.7%)		1/3 (33.3%)
Hemoglobin decreased	1/3 (33.3%)		1/3 (33.3%)
Hyperglycemia	0/3 (0%)		1/3 (33.3%)
Hyperkalemia	0/3 (0%)		1/3 (33.3%)
Hypophosphatemia	0/3 (0%)		1/3 (33.3%)
Lymphopenia	1/3 (33.3%)		0/3 (0%)
Metabolism and nutrition disorders
Hypokalemia	0/3 (0%)		2/3 (66.7%)
Musculoskeletal and connective tissue disorders
Back pain	1/3 (33.3%)		1/3 (33.3%)
Joint pain	0/3 (0%)		1/3 (33.3%)
Pain in extremity	1/3 (33.3%)		0/3 (0%)
Nervous system disorders
Peripheral sensory neuropathy	1/3 (33.3%)		0/3 (0%)
Psychiatric disorders
Insomnia	1/3 (33.3%)		0/3 (0%)
Libido decreased	1/3 (33.3%)		0/3 (0%)
Renal and urinary disorders
Hemorrhage urinary tract	0/3 (0%)		1/3 (33.3%)
Urinary frequency	1/3 (33.3%)		1/3 (33.3%)
Urogenital disorder	0/3 (0%)		1/3 (33.3%)
Reproductive system and breast disorders
Erectile dysfunction	0/3 (0%)		1/3 (33.3%)
Skin and subcutaneous tissue disorders
Coarse hair	1/3 (33.3%)		0/3 (0%)
Rash	0/3 (0%)		1/3 (33.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.