Fulvestrant in Treating Patients With Recurrent Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: fulvestrant
Intervention description: intramuscularly
Intervention MeSH terms: Fulvestrant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: Male
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; recurrent 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.
    

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