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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
therapeutic testosterone
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring stage IV prostate cancer, recurrent prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 5, 2000
Last Updated
January 17, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00006044
Brief Title
Testosterone in Treating Patients With Progressive Prostate Cancer That No Longer Responds to Hormone Therapy
Official Title
A Phase I Trial of Testosterone in Patients With Progressive Androgen-Independent Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
February 2000 (undefined)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage IV prostate cancer, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
therapeutic testosterone

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Morris, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19375217
Citation
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.
Results Reference
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Testosterone in Treating Patients With Progressive Prostate Cancer That No Longer Responds to Hormone Therapy

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