Fulvestrant in Treating Patients With Recurrent Prostate Cancer
Fulvestrant in Treating Patients With Recurrent Prostate Cancer
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.
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