Overview
Toremifene Followed by Radical Prostatectomy in Treating Patients With Stage I or Stage II Prostate Cancer
Status:
Completed
Completed
Trial end date:
2009-06-01
2009-06-01
Target enrollment:
0
0
Participant gender:
Male
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Joel Nelson, MDCollaborator:
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