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



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

For Condition: recurrent prostate cancer,stage 4 prostate cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MichaelMorris,  Study Chair,  Memorial Sloan-Kettering Cancer Center

Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City,  New York,  10021
United States
Recruiting Howard  Scher 646-422-4323


Additional Information:
Study ID Numbers:  CDR0000068060;  MSKCC-99115,NCI-G00-1818
Study Start Date: 
Record last reviewed: May 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006044

Other Stage 4 Prostate Cancer Studies:
1. Hormone Therapy With or Without Mitoxantrone and Prednisone in Treating Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer

2. Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer

3. Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

4. Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer

5. Calcitriol and Zoledronate in Treating Patients With Progressive Prostate Cancer

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