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

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring stage IV prostate cancer, recurrent prostate cancer
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
Sites / Locations
- Memorial Sloan-Kettering Cancer Center