NCT00181597

Brief Summary

The main purpose of this study is to test the safety of trilostane by looking at what effects, good and bad, it has on patients with androgen-independent prostate cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2 prostate-cancer

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

December 3, 2013

Status Verified

December 1, 2013

Enrollment Period

1.8 years

First QC Date

September 9, 2005

Last Update Submit

December 2, 2013

Conditions

Prostate CancerProstate Adenocarcinoma

Keywords

TrilostaneAndrogen-independent prostate cancer

Outcome Measures

Primary Outcomes (1)

  • activity of trilostane in men with androgen-independent prostate cancer.

    4 years

Secondary Outcomes (1)

  • serum levels of gonadal and adrenal steroids

    4 years

Interventions

TrilostaneDRUG

Taken orally once a day for three days then twice daily thereafter.

HydrocortisoneDRUG

Taken orally with trilostane.

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed prostate adenocarcinoma
  • Disease progression despite androgen depravation therapy and antiandrogen withdrawal
  • Progressive measurable disease or bone scan progression or PSA progression
  • Serum total testosterone \< 50ng/ml
  • Creatinine \< 2.0 mg/dl
  • ALT \< 2 x ULN
  • CALGB performance status of 0,1, or 2

You may not qualify if:

  • Radiation therapy within 4 weeks
  • Antiandrogen within 8 weeks
  • Other secondary hormonal therapy or investigational agents within 4 weeks
  • Prior chemotherapy for androgen-independent prostate cancer
  • History of adrenal insufficiency
  • Known brain metastases
  • Severe liver or renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

trilostaneHydrocortisone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Officials

  • Medical Monitor

    Genzyme, a Sanofi Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

March 1, 2004

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

December 3, 2013

Record last verified: 2013-12

Locations

US(2)