Testosterone in Castration-Resistant Prostate Cancer

This study has been withdrawn prior to enrollment.
(Zero accrual and failure to generate multicenter interest.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00577980
First received: December 17, 2007
Last updated: April 25, 2013
Last verified: April 2013
  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:

  1. To assess the objective response and time-to-progression with TRT in CRPC.
  2. To assess serial changes in quality of life with TRT in these CRPC subsets.
  3. 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 2

Study Type: Interventional
Study Design: 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:


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

Primary Outcome Measures:
  • Rate of Prostate Specific Antigen (PSA) - decline by 50% [ Time Frame: Every 2 weeks, after Week 8 every 4 weeks till end of study ] [ Designated as safety issue: No ]
    Rate is the number of participants with PSA-response defined as PSA > or equal to 50%-decline in PSA from baseline value sustained for at least 4 weeks with be no evidence of progressive disease.


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
Testosterone 200 mg administered parenterally by intramuscular (IM) injection every 2 weeks
Drug: Testosterone
Initial dose of Testosterone 200 mg IM administered followed by 200 mg - 400 mg 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 * institutional upper limit of normal (ULN) and serum aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) </= 2.5 * institutional ULN.
  • The Eastern Cooperative Oncology Group (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Paul Mathew, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00577980     History of Changes
Other Study ID Numbers: 2006-0316
Study First Received: December 17, 2007
Last Updated: April 25, 2013
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 Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014