Prostate Cancer Clinical Trial
Testosterone in Treating Patients With Progressive Prostate Cancer That No Longer Responds to Hormone Therapy
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.
Full 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.
Eligibility 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
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There is 1 Location for this study
New York New York, 10021, United States
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