Maintaining Suppression of Testosterone With Transdermal Estradiol Gel
Condition: Cancer of the Prostate
MeSH terms: Prostatic Neoplasms
Intervention: BHR-200 (0.36% transdermal 17β-estradiol gel); Placebo
Intervention description: An absorptive hydroalcoholic gel preparation containing 17β-estradiol.; An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol.
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this clinical study is to evaluate the safety and efficacy of three
      different doses of BHR-200 (0.36% transdermal estradiol gel) compared to placebo for the
      maintenance of testosterone (T) suppression in men with advanced androgen-sensitive prostate
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males, Ages 18 and older

          2. Body Mass Index (BMI) between 18 and 35 kg/m2 (inclusive)

          3. Not currently hospitalized

          4. Clinical indication of adenocarcinoma of the prostate evidenced by a biopsy report on
             record

          5. At present receiving ADT treatment with a GnRH agonist for at least 2 months but not
             longer than 36 months without interruption - Note: If the patient received GnRH
             agonist treatment prior to the treatment described under 5, there must be evidence of
             a period without GnRH agonist treatment for a minimum of 2 months prior to starting
             the present treatment as is seen, for example with intermittent treatment regimens.

          6. Able to initiate Screening procedures 2 weeks prior to the next scheduled injection
             with a GnRH agonist

          7. Willing to discontinue current ADT regimen for the duration of the study

          8. T level less than 50 ng/dL at Screening

          9. WHO/ECOG performance status of 0 or 1

         10. Life expectancy of at least 1 year

         11. Adequate renal function demonstrated by having normal blood urea nitrogen (BUN) and
             Creatinine Screening lab values

        Exclusion Criteria:

          1. History or presence of allergic or adverse response to estradiol

          2. Presence of symptomatic metastatic disease, risk of spinal cord compression or urinary
             obstruction

          3. History within the past 2 years of deep vein thrombosis (DVT), pulmonary embolism
             (PE2), a known thrombophilic disorder (eg.protein C, protein S, or antithrombin
             deficiency), or cerebrovascular accident (CVA)

          4. History within the past 2 years of myocardial infarction or a coronary vascular
             procedure (e.g. percutaneous coronary intervention, coronary artery bypass graft)

          5. History of congestive heart failure

          6. Use of any investigational drug, biologic, or device within 28 days prior to the first
             dose of study gel

          7. Use of any of the following known inducers or inhibitors of cytochrome P450 3A4
             (CYP3A4): phenobarbital, carbamazepine, rifampin, erythromycin, clarithromycin,
             ketoconazole, itraconazole, ritonavir, St. John's Wort preparations (Hypericum
             perforatum), and grapefruit juice

          8. Hematological parameters (Hematocrit or Hemoglobin) outside 20% of the upper or lower
             limits of normal at Screening

          9. Active skin rash, sunburn, or other skin disorder on the upper arm(s) that requires
             treatment or may affect skin absorption of study gel

         10. Resting uncontrolled hypertension (HTN) (160/100 mmHg) at Screening

         11. Co-existent malignancy or a history of malignancy during the past 5 years, with the
             exception of basal and/or squamous cell carcinoma of the skin

         12. Any other significant concurrent illness or disease or condition that in the opinion
             of the Investigator might interfere with the patient's ability to receive the
             treatment outlined in the protocol or might put him at additional risk