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Testosterone in Treating Patients With Progressive Prostate Cancer That No Longer Responds to Hormone Therapy
This study is ongoing, but not recruiting participants.
First Received: July 5, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006044
  Purpose

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 I

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Trial of Testosterone in Patients With Progressive Androgen-Independent Prostate Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006044

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Michael Morris, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068060, MSKCC-99115, NCI-G00-1818
Study First Received: July 5, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00006044     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV prostate cancer
recurrent prostate cancer

Study placed in the following topic categories:
Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Methyltestosterone
Genital Diseases, Male
Hormones
Recurrence
Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:
Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Methyltestosterone
Genital Diseases, Male
Hormones
Pharmacologic Actions
Testosterone 17 beta-cypionate
Anabolic Agents
Neoplasms
Testosterone
Neoplasms by Site
Therapeutic Uses
Prostatic Neoplasms
Androgens

ClinicalTrials.gov processed this record on May 06, 2009