Trilostane for Androgen-Independent Prostate Cancer

Genzyme

Status and phase

Completed

Phase 2

Conditions

Prostate Adenocarcinoma

Prostate Cancer

Treatments

Drug: Hydrocortisone

Drug: Trilostane

Study type

Interventional

Funder types

Industry

Identifiers

NCT00181597

04-037

Details and patient eligibility

About

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.

Full description

Patients will take trilostane orally once a day for three days, then twice a day thereafter.
Patients will complete a daily drug log recording the date, time and number of capsules taken.
Trilostane may moderately decrease the production of steroids by the adrenal glands. In order to prevent any symptoms related to decreased steroid production, patients will also take hydrocortisone at the same time as the trilostane.
While the patients are on treatment blood work will be done after 2 weeks and then every 4 weeks to test the levels of PSA in the blood. On weeks 4 and 8 of treatment additional blood work will be done to check hormone levels. Blood pressure and pulse rate will also be taken every 4 weeks.
Depending upon disease status, radiological testing (CT scan, x-rays, and/or bone scan) may be repeated every 12 weeks.
Patients will remain on study treatment as long as their disease responds and they do not experience any severe side effects.

Enrollment

24 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria