fulvestrant in treating patients with recurrent prostate cancer

Conditions: Prostate Cancer

Summary: rationale: estrogen may cause the growth of prostate cancer cells. hormone therapy using fulvestrant may fight prostate cancer by blocking the use of estrogen by the tumor cells. purpose: this phase ii trial is studying how well fulvestrant works in treating patients with recurrent prostate cancer.

objectives: primary * determine whether fulvestrant can slow the rise of prostrate-specific antigen (psa) level in patients with early recurrent adenocarcinoma of the prostate after radical prostatectomy or irradiation. secondary * determine the utility of monitoring serum psa in patients treated with this drug. * determine the safety of this drug in these patients. * determine changes in bone mineral density and markers of bone resorption in patients with psa-only failure treated with this drug. outline: this is an open-label, single group assignment study. patients receive fulvestrant intramuscularly on days 0, 14, and 28. treatment repeats once a month in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed periodically. projected accrual: a total of 32 patients will be accrued for this study for 84 months.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the prostate * early recurrent disease, defined by 1 of the following criteria: * prostate-specific antigen (psa) ≥ 2.0 ng/ml and clearly rising within the past 3 months for patients who underwent prior prostatectomy with or without radiotherapy * psa ≥ 4.0 ng/ml and clearly rising from the lowest value obtained within the past 6 months for patients who underwent prior definitive radiotherapy only * no evidence of clinical recurrence,\* as defined by the following criteria: * digital rectal exam negative * no local recurrence by ct scan or mri of the pelvis * no evidence of bone metastasis by bone scan note: \*prostascint scan results are not considered evidence of recurrence * underwent prior curative treatment comprising radical prostatectomy with or without adjuvant radiotherapy or definitive radiotherapy alone * testosterone (total or free) \> than lower limit of normal patient characteristics: age * any age performance status * ecog 0-1 life expectancy * not specified hematopoietic * wbc \> 3,500/mm\^3 * platelet count \> 100,000/mm\^3 * no history of bleeding diathesis hepatic * inr \< 1.6 * bilirubin ≤ 1.5 times upper limit of normal (uln) * alt or ast ≤ 2.5 times uln * no severe hepatic impairment that would preclude study participation or compliance renal * creatinine ≤ 2.0 mg/dl * no severe renal impairment that would preclude study participation or compliance cardiovascular * no unstable or uncompensated cardiac condition that would preclude study participation or compliance pulmonary * no unstable or uncompensated respiratory condition that would preclude study participation or compliance other * no history of hypersensitivity to active or inactive excipients of fulvestrant (e.g., castor oil) * no other severe condition that would preclude study compliance (e.g., abuse of alcohol or drugs or psychotic states) or participation prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * more than 6 months since prior neoadjuvant or adjuvant androgen deprivation therapy or luteinizing hormone-releasing hormone antagonist therapy * no other prior or concurrent hormonal therapy radiotherapy * see disease characteristics * no concurrent radiotherapy surgery * see disease characteristics other * more than 4 weeks since prior experimental drug treatment * no concurrent anticoagulant therapy except antiplatelet therapy * no other concurrent therapy for prostate cancer * no other concurrent therapy known or suspected of altering androgen metabolism or androgen levels

Keywords: adenocarcinoma of the prostate recurrent prostate cancer