Multicenter Study of Fulvestrant (Faslodex®) in Early, Recurrent Prostate Cancer Following Local Therapy: A Phase II Trial

Inclusion 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