Fulvestrant in Treating Patients With Recurrent Prostate Cancer

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