Testosterone in Castration-Resistant Prostate Cancer - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00577980

Purpose

Primary Objective:

1. To assess the prostate-specific antigen (PSA)-response (50% decline) to Testosterone Replacement Therapy (TRT) in men with "intermediate and good-risk" Castration-Resistant Prostate Cancer (CRPC).

Secondary Objectives:

To assess the objective response and time-to-progression with TRT in CRPC.
To assess serial changes in quality of life with TRT in these CRPC subsets.
Translational: To study kinetics of circulating tumor cells with TRT and molecular correlates of response to TRT in CRPC.

Condition	Intervention	Phase
Prostate Cancer	Drug: Testosterone	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Testosterone Replacement Therapy in Castration-Resistant Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Rate of PSA-decline by 50% [ Time Frame: Every 2 weeks, after Week 8 every 4 weeks till end of study ] [ Designated as safety issue: No ]

Enrollment:	0
Study Start Date:	December 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Testosterone	Drug: Testosterone Administered parenterally by intramuscular injection every 2 weeks

Detailed Description:

Generally, castration therapy has been used indefinitely for prostate cancer patients because some tumors seem to grow faster with testosterone present. Researchers want to study the effect of testosterone only in patients whose tumors have had a maximum response to castration therapy. Researchers want to find out if these patients' disease may be better controlled with testosterone replacement therapy.

Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your complete medical history will be recorded and there will be a review of all medicines you may be currently taking. You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate). You will have blood drawn (about 4 teaspoons) and urine collected for routine tests. You will have a chest x-ray, an electrocardiogram (ECG--a test to measure the electrical activity of the heart), a bone scan, and a computed tomography (CT) scan of your abdomen and pelvis. If the study doctor thinks it is necessary, you may have an assessment of your mental status. For this assessment, you will be asked questions about your attention span, memory, and mood disturbances. It will take about 25 minutes to complete.

If you are found to be eligible to take part in this study, you will begin receiving testosterone enanthate replacement therapy every 2 weeks by an injection into a muscle.

Every 2 weeks, you will go to the clinic for your testosterone injection, and blood (about 2 teaspoons) will be drawn to check the testosterone level in your blood. This will help the study doctor learn what dose you will receive for the next 2 weeks. After your Week 8 visit, blood (about 2 teaspoons) will be drawn to check the testosterone level in your blood every 4 weeks for the rest of your time on this study.

At the Week 8 and 24 visits, you will have a physical exam, including measurement of your vital signs. You will be asked about any side effects you may be experiencing. Your disease status will be evaluated to learn its response to treatment. Blood (about 4 teaspoons) will be drawn for routine tests, and you will have repeat imaging scans (like the ones you had at your screening visit) to evaluate your disease. If the study doctor thinks that your mental status should be assessed again, you will have another assessment (at or around Week 24) like the one completed during your screening visit.

You may remain on this study indefinitely unless your disease gets worse or you experience any intolerable side effects.

If your participation ends on this study for any of the above reasons, you will have an end-of-study visit. During this visit, you will have blood drawn (about 4 teaspoons) for routine testing. You will be asked about any side effects you may be experiencing, and your disease response to treatment will be evaluated.

This is an investigational study. Testosterone enanthate is commercially available. Testosterone replacement therapy is not FDA approved for this disease, and in some cases, has been disallowed for use in prostate cancer. Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have a history of histologically or cytologically confirmed adenocarcinoma of the prostate.
Patients must have had a history of a response to medical or surgical castration therapy for prostate cancer with a serum PSA nadir of </= 0.2 ng/ml and must not have had any known subsequent rise in serum PSA level of any magnitude above this nadir within the first 24 months of hormonal therapy. Nadir PSA value following hormonal therapy in combination with non-hormonal therapy such as radical prostatectomy, radiation therapy or chemotherapy do not count towards eligibility.
Patients must have current evidence of progressive castration-resistant disease that is asymptomatic. Progressive disease is defined by a) radiological evidence of progression: any increase of > 25% in the products of diameters or 30% in maximum diameter of any measurable lesion; or appearance of an unequivocally new lesion OR b) two consecutive rises in serum PSA of any magnitude measured at least 2 weeks apart, to a level above 2 ng/ml.
Patients must have a minimum serum PSA level of 1 ng/ml.
Patients may have palpable disease or radiological evidence of metastatic disease but without the following high-risk features: lymphangitic lung disease on chest X-ray or CT scan; bilateral hydronephrosis related to prostate cancer, palpable disease in the prostate, known brain metastases or suspicion of impending spinal cord or nerve root compression.
Patients must have a documented castrate level of testosterone (</= 50ng/ml). For patients who are medically castrated, luteinizing hormone releasing hormone analog will continue. The purpose is to simplify and harmonize exogenous testosterone therapeutics.
Patients on anti-androgens should be discontinued from such therapy for at least 4 weeks (for bicalutamide for at least 6 weeks), prior to initiation of testosterone therapy and must have had documented progression of disease as in #3.
Patients must satisfy the following laboratory criteria: serum total bilirubin < 2 x institutional ULN and serum AST and ALT </= 2.5 x institutional ULN.
ECOG performance status 0-3.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Small cell or sarcomatoid prostate cancers are not eligible.
No prior chemotherapy for CRPC.
Patients may not be receiving any other investigational agents or hormonal therapy besides that specified in the study.
Uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infections defined as requiring IV antibiotics on day 1 of treatment or psychiatric illness/social situations that would limit compliance with study requirements.
Unwilling or unable because of comorbid conditions to tolerate intramuscular injections of testosterone every 2 weeks.
Overt psychosis, mental disability or otherwise incompetent to give informed consent or history of non-compliance.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577980

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Paul Mathew, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Paul Mathew, MD/Assistant Professor, U.T.M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00577980 History of Changes
Other Study ID Numbers:	2006-0316
Study First Received:	December 17, 2007
Results First Received:	September 4, 2009
Last Updated:	October 7, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Prostate Cancer
Castration-Resistant Prostate Cancer
Testosterone Replacement Therapy

Testosterone
CRPC
TRT

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate

Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on February 09, 2012