Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 and over	NCI	MSKCC-99115 NCI-G00-1818, NCT00006044

Objectives

1. 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.
2. 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.

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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,500/mm³
• Platelet count greater than 100,000/mm³

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

Expected Enrollment

A total of 3-18 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Michael Morris, MD, Protocol chair		Ph: 646-422-4469; 800-525-2225

Registry Information
Official Title		A Phase I Trial of Testosterone in Patients with Progressive Androgen-Independent Prostate Cancer
Trial Start Date		2000-02-22
Registered in ClinicalTrials.gov		NCT00006044
Date Submitted to PDQ		2000-06-07
Information Last Verified		2004-08-11
NCI Grant/Contract Number		CA05826, CA08748

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