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

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center Identifier:
First received: July 5, 2000
Last updated: January 17, 2013
Last verified: January 2013

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.

Condition Intervention Phase
Prostate Cancer
Drug: therapeutic testosterone
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Trial of Testosterone in Patients With Progressive Androgen-Independent Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Memorial Sloan Kettering Cancer Center:

Study Start Date: February 2000
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified


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


  • Bilirubin less than 2.0 mg/dL
  • SGOT less than 3 times upper limit of normal
  • PTT less than 14 seconds


  • Creatinine less than 2.0 mg/dL OR
  • Creatinine clearance greater than 60 mL/min


  • No New York Heart Association class III or IV cardiac disease


  • No severe debilitating pulmonary disease


  • No infection requiring IV antibiotics
  • No other severe medical problems that would increase risk for toxicity


Biologic therapy:

  • Recovered from prior biologic therapy
  • No concurrent immunotherapy


  • 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


  • Recovered from prior radiotherapy
  • No concurrent radiotherapy to an indicator lesion


  • See Disease Characteristics
  • Recovered from prior surgery
  • No concurrent surgery on only measurable lesion


  • At least 4 weeks since other prior investigational anticancer drugs and recovered
  • No other concurrent investigational anticancer agents
  Contacts and Locations
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Please refer to this study by its identifier: NCT00006044

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Michael Morris, MD Memorial Sloan Kettering Cancer Center
  More Information

Publications: Identifier: NCT00006044     History of Changes
Other Study ID Numbers: 99-115
P30CA008748 ( US NIH Grant/Contract Award Number )
P01CA005826 ( US NIH Grant/Contract Award Number )
Study First Received: July 5, 2000
Last Updated: January 17, 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents processed this record on April 28, 2017