NCT00006044

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2000

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2000

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Last Updated

January 18, 2013

Status Verified

January 1, 2013

Enrollment Period

5 years

First QC Date

July 5, 2000

Last Update Submit

January 17, 2013

Conditions

Prostate Cancer

Keywords

stage IV prostate cancerrecurrent prostate cancer

Interventions

therapeutic testosteroneDRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related 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):237-44. doi: 10.1016/j.eururo.2009.03.073. Epub 2009 Apr 3.

    PMID: 19375217RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Testosterone Propionate

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TestosteroneAndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Michael Morris, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2000

First Posted

January 27, 2003

Study Start

February 1, 2000

Primary Completion

February 1, 2005

Last Updated

January 18, 2013

Record last verified: 2013-01

Locations

US(1)