Prostate Cancer
Conditions
Keywords
stage IV prostate cancer, recurrent prostate cancer
Brief summary
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
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.
Interventions
Sponsors
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Countries
United States
Outcome results
None listed