Phase II Trial of Transdermal Estradiol for Hormone Refractory Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Transdermal Estradiol
Intervention description: application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.
The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed.
Intervention MeSH terms: Estradiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: prostate cancer

Summary:

      Multiple trials have shown the efficacy of estrogen therapy in metastatic prostate cancer,
      and most recently trials have supported the use of transdermal estrogens (patch) in the
      patient population with a decreased risk of cardiovascular disease as compared to the oral
      estrogens. We plan to study the use of transdermal estrogen at a dose of 0.4mg qd. We will
      evaluate the toxicities and measure quality of life. We will assess PSA response and
      measurable disease response. This will be a trial available to the Cancer Institute of New
      Jersey Oncology Group. We will enroll a total of 33 patients. We will plan to enroll 10 at
      CINJ.Patients will wear the patches (4) continuously. We will obtain blood work and clinic
      evaluations every three weeks. We will assess quality of life through a questionnaire given
      to patient every three weeks.
    

Eligibility criteria:

        Inclusion Criteria

          -  Patients with metastatic prostate adenocarcinoma, who have failed initial hormone
             therapy and who have had progression after at least one chemotherapy regimen that
             included docetaxel. Patients on antiandrogens must have progression after withdrawal
             of the antiandrogen for 4 weeks (flutamide) or 6 weeks (bicalutamide).

          -  PSA ≥ 10 ng/ml.

          -  Patients who have received LHRH agonist therapy for > 1 month must maintain agonist
             therapy while on-study. Patients who have not received agonist therapy or received < 1
             month of therapy, may not begin or continue agonist therapy while on-study.

          -  Age >18 years and an estimated life expectancy of at least 4 months.

          -  ECOG performance status ≤ 2 (see Appendix B).

          -  Full recovery from the effects of any prior surgery or radiation therapy within 4
             weeks of study entry.

          -  Serum creatinine ≤ 1.5 x ULN

          -  Total bilirubin < ULN

          -  Transaminases (SGOT and/or SGPT) ≤ 2 X institutional upper limit.

          -  Capacity to give informed, written consent.

        Exclusion Criteria

          -  Any coexisting medical condition precluding full compliance with the study.

          -  Any history of deep venous thrombosis (DVT) or pulmonary embolus. Patients with a DVT
             on anticoagulants for ≥ 6 months will be eligible.

          -  Known CNS metastasis.

          -  The discontinuation of flutamide or bicalutamide < 4 or 6 weeks respectively.

          -  History of severe cardiovascular disease (AHA class III or IV; see Appendix C),
             uncontrolled CHF or life threatening cardiac dysrhythmia in the past 6 months.

          -  Herbal supplements may not be used while on-study and patients must have discontinued
             use for ≥ 1 week before entering on-study.

          -  Patients with a known hypersensitivity to estrogen.

          -  Triglyceride > 200 mg/dl.

          -  Prior estramustine.