Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Recurrence

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Androgens

Hormones

Testosterone

Hormone Antagonists

therapeutic testosterone

Michael Morris, MD

RATIONALE: High doses of testosterone may be effective in killing prostate cancer cells that no longer respond to hormone therapy.

PURPOSE: Phase I trial to study the effectiveness of testosterone in treating patients who have progressive prostate cancer that no longer responds to hormone therapy.

OBJECTIVES:

* Determine the safety and maximum tolerated dose of exogenously administered testosterone in patients with progressive androgen-independent prostate cancer who have been in castrate state either surgically or pharmacologically for a minimum of 1 year.
* Assess the changes in expression of androgen receptor and other receptors in human biopsy specimens or circulating tumor cells before and after this treatment in this patient population.

OUTLINE: This is a dose-escalation study.

Patients receive testosterone via an enhanced absorption transdermal system continuously for 28 days. The transdermal patches are changed daily.

Cohorts of 3-6 patients receive a fixed daily dose of testosterone with escalating duration of exposure until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicities.

Patients are followed at day 1 and at weeks 2 and 4.

PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study.

Testosterone in Treating Patients With Progressive Prostate Cancer That No Longer Responds to Hormone Therapy

A Phase I Trial of Testosterone in Patients With Progressive Androgen-Independent Prostate Cancer

National Cancer Institute (NCI)

Memorial Sloan Kettering Cancer Center

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Reproductive Control Agents

Estradiol

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Polyestradiol phosphate

Deslorelin

Estrogens

Contraceptive Agents

Contraceptive Agents, Hormonal

Contraceptive Agents, Female

Enzyme Inhibitors

Patients receive deslorelin, estradiol, and testosterone intranasally QD for 6 months. Patients then undergo planned risk reduction mastectomy.

Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months. Patients then undergo continued surveillance through 10 months.

therapeutic estradiol

deslorelin

therapeutic conventional surgery

active surveillance

quality-of-life assessment

laboratory biomarker analysis

Jeffrey Weitzel, MD

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Deslorelin combined with low-dose add-back estradiol and testosterone (given to replace hormones suppressed by deslorelin) may be effective in preventing breast cancer in at-risk women.

PURPOSE: This phase II trial is studying how well giving deslorelin together with estradiol and testosterone works in preventing breast cancer in premenopausal women who are at high risk for this disease.

OBJECTIVES:

I. Assess the effects on the breast of treatment with the gonadotropin-releasing hormone agonist (GnRHA)-based regimen in breast cancer (BRCA) gene mutation carriers, including correlation of changes in mammographic and magnetic resonance imaging (MRI) densities with tissue morphometrics and biomarkers.

II. Evaluate perspectives about risk reduction options and impact on quality-of-life (QOL) measures of participation in the chemopreventive protocol and in risk reduction surgery.

OUTLINE:

GROUP 1: Patients receive deslorelin, estradiol, and testosterone intranasally once daily (QD) for 6 months. Patients then undergo planned risk reduction mastectomy.

GROUP 2: Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months. Patients then undergo continued surveillance through 10 months.

After completion of study treatment, patients are followed up every 6 months for 2 years.

Deslorelin Combined With Low-Dose Add-Back Estradiol and Testosterone in Preventing Breast Cancer in Premenopausal Women Who Are at High Risk for This Disease

Biomarkers, Breast Density And Risk Reduction Perspectives In BRCA Carriers

City of Hope Medical Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Testosterone in Treating Patients With Progressive Prostate Cancer That No Longer Responds to Hormone Therapy	NCT00006044	Prostate Cancer	therapeutic tes...	18 Years -	Memorial Sloan Kettering Cancer Center
Testosterone in Treating Patients With Progressive Prostate Cancer That No Longer Responds to Hormone Therapy	NCT00006044	Prostate Cancer	therapeutic tes...	18 Years -	Memorial Sloan Kettering Cancer Center
Deslorelin Combined With Low-Dose Add-Back Estradiol and Testosterone in Preventing Breast Cancer in Premenopausal Women Who Are at High Risk for This Disease	NCT00080756	brca1 Mutation ... brca2 Mutation ... Breast Cancer	therapeutic est... deslorelin therapeutic tes... therapeutic con... active surveill... quality-of-life... laboratory biom...	21 Years - 48 Years	City of Hope Medical Center

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