Overview

Toremifene Followed by Radical Prostatectomy in Treating Patients With Stage I or Stage II Prostate Cancer

Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
0
Participant gender:
Male
Summary
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using toremifene may fight prostate cancer by reducing the production of androgens. PURPOSE: Randomized phase II trial to study the effectiveness of toremifene followed by radical prostatectomy in treating patients who have stage I or stage II prostate cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Joel Nelson, MD
Collaborator:
National Cancer Institute (NCI)
Treatments:
Toremifene
Criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate

- Organ-confined (cT1-2) disease (stage I or II)

- Must be schedule to undergo radical prostatectomy

- Prior sextant biopsy required

PATIENT CHARACTERISTICS:

Age:

- Over 18

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Neutrophil count greater than 1,500/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic:

- Bilirubin less than 1.5 times upper limit of normal (ULN)

- ALT and AST less than 2 times ULN

- Alkaline phosphatase less than 2 times ULN

- No chronic hepatitis or cirrhosis

Renal:

- Creatinine less than 1.5 times ULN

Other:

- No severe mental or physical illness that would preclude radical prostatectomy

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- At least 5 years since prior antiestrogen, antiandrogen, LHRH agonist, estrogen, or
progestational agent

Radiotherapy:

- Not specified

Surgery:

- See Disease Characteristics