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

January 17, 2013 updated by: Memorial Sloan Kettering Cancer Center

A Phase I Trial of Testosterone in Patients With Progressive Androgen-Independent Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2000

Primary Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

July 5, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

January 18, 2013

Last Update Submitted That Met QC Criteria

January 17, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99-115
  • P30CA008748 (U.S. NIH Grant/Contract)
  • P01CA005826 (U.S. NIH Grant/Contract)
  • MSKCC-99115
  • NCI-G00-1818

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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