A Phase 2 interventional study of genistein and conventional surgery in Prostate Cancer, sponsored by Northwestern University. Terminated at 5 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-19.
Sponsored by Northwestern University · Phase 2, Interventional, and Treatment
RATIONALE: Genistein may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase II trial to study the effectiveness of genistein in treating patients with localized prostate cancer who are planning to undergo radical prostatectomy.
OBJECTIVES:
OUTLINE: Patients receive 1 of 2 treatment regimens.
Quality of life is assessed at baseline and at 1 and 3 months after surgery.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 88 patients (44 patients per treatment group) will be accrued for this study within 2 years.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 36 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of localized prostate cancer
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Patients receive oral genistein once daily for 1-2 months, undergo radical prostatectomy, and then continue oral genistein once daily for 1-2 months afterward (for a total of 3 months of therapy).
Dietary Supplement: genistein · Procedure: conventional surgery
Patients undergo radical prostatectomy. Beginning 1 month after surgery, patients receive genistein as in arm I for 3 months.
Dietary Supplement: genistein · Procedure: conventional surgery
Given orally
Patients undergo surgery
Toxicity
Time frame: At surgery & monthly thereafter during treatment (3 mos)
Decrease in prostate-specific antigen-positive cells
Time frame: At time of surgery
Alteration in cell morphology
Time frame: At time of surgery
This study is terminated, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Northwestern University