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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006044
• Other study ID #: 99-115
• Secondary ID: P30CA008748P01CA
• Status: Completed
• Phase: Phase 1
• First received: July 5, 2000
• Last updated: January 17, 2013
• Start date: February 2000

Study information

• Verified date: January 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• therapeutic testosterone

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation