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