Fulvestrant in Treating Patients With Recurrent Prostate Cancer
Prostate Cancer

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer
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
Sites / Locations
- Roswell Park Cancer Institute
Arms of the Study
Arm 1
Experimental
Fulvestrant
Fulvestrant will be provided as 250 mg in 5 mL as a pre-tilled syringe. Fulvestrant will be administered as 500 mg, that is, 2 injections of 5 mL, one into each buttock im on day 0. A single 250 mg in 5 mL injection will be administered on day 14 followed by a single 250 mg in 5 mL dose on day 28 and monthly thereafter.