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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006044
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 18, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

July 5, 2000
January 27, 2003
January 18, 2013
February 2000
February 2005   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00006044 on Archive Site
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Testosterone in Treating Patients With Progressive Prostate Cancer That No Longer Responds to Hormone Therapy
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.


  • 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.

Phase 1
Primary Purpose: Treatment
Prostate Cancer
Drug: therapeutic testosterone
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Morris MJ, Huang D, Kelly WK, Slovin SF, Stephenson RD, Eicher C, Delacruz A, Curley T, Schwartz LH, Scher HI. Phase 1 trial of high-dose exogenous testosterone in patients with castration-resistant metastatic prostate cancer. Eur Urol. 2009 Aug;56(2):237-44. doi: 10.1016/j.eururo.2009.03.073. Epub 2009 Apr 3.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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February 2005   (Final data collection date for primary outcome measure)


  • 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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
P30CA008748 ( U.S. NIH Grant/Contract )
P01CA005826 ( U.S. NIH Grant/Contract )
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Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Michael Morris, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP