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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: therapeutic testosterone


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed androgen independent metastatic prostate cancer Progressive disease manifested by either: New osseous lesions by bone scan or a greater than 25% increase in bidimensionally measurable soft tissue disease or the appearance of new sites of disease by MRI or CT scan OR Minimum of 3 rising PSA values from baseline that are obtained 1 week or more apart, or 2 rising PSA values more than 1 month apart, where the percentage increase over the range of values is at least 25% Castrate state by orchiectomy or gonadotropin-releasing hormone analogues for minimum of 1 year Testosterone no greater than 30 ng/mL Measurable disease Metastatic disease by bone scan, MRI, or CT scan Rising PSA values If receiving antiandrogen therapy, must have shown progressive disease off treatment No active CNS or epidural tumor PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Bilirubin less than 2.0 mg/dL SGOT less than 3 times upper limit of normal PTT less than 14 seconds Renal: Creatinine less than 2.0 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No New York Heart Association class III or IV cardiac disease Pulmonary: No severe debilitating pulmonary disease Other: No infection requiring IV antibiotics No other severe medical problems that would increase risk for toxicity PRIOR CONCURRENT THERAPY: Biologic therapy: Recovered from prior biologic therapy No concurrent immunotherapy Chemotherapy: Recovered from prior chemotherapy No concurrent chemotherapy Endocrine therapy: See Disease Characteristics If no prior orchiectomy, must continue on gonadotropin-releasing hormone analogs to maintain castrate levels of testosterone No concurrent finasteride No other concurrent hormonal therapy Radiotherapy: Recovered from prior radiotherapy No concurrent radiotherapy to an indicator lesion Surgery: See Disease Characteristics Recovered from prior surgery No concurrent surgery on only measurable lesion Other: At least 4 weeks since other prior investigational anticancer drugs and recovered No other concurrent investigational anticancer agents

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: therapeutic testosterone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV prostate cancer, recurrent prostate cancer