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A Phase II Study of Trilostane for Androgen-Independent Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer, Prostate Adenocarcinoma

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Trial Information

A Phase II Study of Trilostane for Androgen-Independent Prostate Cancer

- Patients will take trilostane orally once a day for three days, then twice a day

- Patients will complete a daily drug log recording the date, time and number of capsules

- 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.

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:

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2004

Completion Date:

January 2006

Related Keywords:

  • Prostate Cancer
  • Prostate Adenocarcinoma
  • Trilostane
  • Androgen-independent prostate cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617