Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: Fulvestrant in Treating Patients With Advanced 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 advanced prostate cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Determine if the prostate-specific antigen objective response (complete and partial response) rate is > 0.2 in patients with androgen-independent advanced prostate cancer treated with fulvestrant.
  Secondary
  -  Determine the toxicity of this drug in these patients.
  OUTLINE: This is an open-label study.
  Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Courses repeat once a month in the absence of disease progression or unacceptable toxicity.
  After completion of study treatment, patients are followed periodically for survival.
  PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed adenocarcinoma of the prostate
  -  Advanced disease
  -  Must have androgen-independent prostate cancer meeting the following criteria:
  -  Evidence of rising prostate-specific antigen (PSA) level and absolute value ≥ 5 ng/mL based on 2 measurements taken ≥ 2 weeks apart (measurements must be done after androgen deprivation [orchiectomy or luteinizing hormone-release hormone (LHRH) analogue] and antiandrogen withdrawal)
  -  Rising PSA required for ≥ 28 days after antiandrogen or progestational therapy for prostate cancer (≥ 42 days after bicalutamide or nilutamide)
  -  Testosterone < 50 ng/mL (unless surgically castrated)
  -  Measurable or evaluable disease
  -  PSA elevation constitutes evaluable disease
  PATIENT CHARACTERISTICS:
  Performance status
  -  ECOG 0-2
  Life expectancy
  -  Not specified
  Hematopoietic
  -  WBC > 3,000/mm^3
  -  Neutrophil count ≥ 1,500/mm^3
  -  Platelet count ≥ 100,000/mm^3
  -  Hemoglobin ≥ 8 g/dL (transfusion or epoetin alfa allowed)
  -  No bleeding diathesis (e.g., disseminated intravascular coagulation or clotting factor deficiency)
  Hepatic
  -  Bilirubin normal
  -  Gilbert's disease with bilirubin ≤ 3 times upper limit of normal (ULN) allowed in the absence of other etiology (e.g., hemolysis-reticulocyte count < 5%) and liver function tests normal
  -  SGOT and/or SGPT ≤ 2 times ULN
  -  INR < 1.6
  Renal
  -  Creatinine < 2.5 mg/dL
  Cardiovascular
  -  No unstable cardiac disease requiring medication
  -  No new onset crescendo or rest angina
  -  Stable exertional angina allowed
  Other
  -  Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment
  -  No other active malignancy within the past 2 years except nonmelanoma skin cancer or superficial bladder cancer
  -  No history of significant neurologic or psychiatric disorders, including psychotic disorders, dementia, or seizures
  -  No other serious illness or medical condition
  -  No active infection
  -  No known hypersensitivity to active or inactive excipients of fulvestrant (e.g., castor oil or mannitol)
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Prior retinoids, vaccines, and cytokines are not considered cytotoxic and are allowed
  Chemotherapy
  -  No more than 1 prior cytotoxic chemotherapy regimen
  -  More than 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)
  -  No concurrent chemotherapy
  Endocrine therapy
  -  See Disease Characteristics
  -  Prior glucocorticoids, antiandrogens, progestational agents, estrogens, and LHRH analogues are not considered cytotoxic and are allowed
  -  At least 4 weeks since prior flutamide (6 weeks for bicalutamide or nilutamide)
  -  Concurrent megestrol acetate allowed at a stable dose of ≤ 40 mg/day
  -  Concurrent androgen deprivation using LHRH analogues allowed but must continue during study treatment or orchiectomy is required to maintain castrate levels of testosterone
  Radiotherapy
  -  More than 3 weeks since prior radiotherapy
  -  No concurrent radiotherapy
  Surgery
  -  See Disease Characteristics
  -  See Endocrine therapy
  Other
  -  Recovered from all prior therapy
  -  Prior cholecalciferol analogues, ketoconazole, aminoglutethimide, peroxisome-proliferation-activated receptor-gamma agonists or antagonists, or PC-SPES are not considered cytotoxic and are allowed
  -  No prior long-term anticoagulation therapy (antiplatelet therapy allowed)
  -  More than 4 weeks since prior investigational drugs
  -  No other concurrent anticancer therapy (e.g., PC-SPES)
  -  No concurrent bisphosphonates unless receiving a stable dose at study entry
  -  No concurrent therapy that may alter androgen metabolism or androgen levels
  -  No concurrent full anticoagulation

Relevance to patient case: not relevant