Last updated on February 2018

Prostate Adenocarcinoma TransCutaneous Hormones


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cardiovascular Complications | Anemia | Hot flushes | Malignant neoplasm of prostate | Osteoporosis
  • Age: - 120 Years
  • Gender: Male

DISEASE CHARACTERISTICS:

  • Must meet 1 of the following criteria:
  • Newly diagnosed patients with any of the following:
  • Stage T3 or T4, NX, M0 histologically confirmed prostate adenocarcinoma with prostate-specific antigen (PSA) 20 ng/mL or Gleason score 6
  • Any T, N+, M0, or any T, any N, M+ histologically confirmed prostate adenocarcinoma
  • Multiple sclerotic bone metastases with a PSA 50 ng/mL without histological confirmation
  • Patients with histologically confirmed prostate adenocarcinoma previously treated with radical surgery or radiotherapy who are currently in relapse with on of the
    following
  • PSA 4 ng/mL and rising with doubling time less than 6 months
  • PSA 20 ng/mL
  • Must have written informed consent
  • Intention to treat with long-term androgen-deprivation therapy
  • Normal testosterone level prior to hormonal treatment

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • No other prior or current malignant disease or cardiovascular system disease that is likely to interfere with study treatment or assessment
  • No cardiovascular disease, including any of the following:
  • History of cerebral ischemia (e.g., stroke or transient ischemic attack) within the past 2 years
  • History of deep vein thrombosis or pulmonary embolism confirmed radiologically
  • History of myocardial infarction (MI) within the past 6 months OR MI more than 6 months ago with evidence of q-wave anterior infarct on ECG
  • ECHO or MUGA required for patients with history of ischemic heart disease
  • Left Ventricular Ejection Fraction 40%
  • No condition or situation that could preclude protocol treatment or compliance with follow-up schedule

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 12 months since prior adjuvant or neoadjuvant hormonal therapy for localized prostate cancer AND therapy lasted 12 months in duration
  • No prior systemic therapy for locally advanced or metastatic prostate cancer
  • No concurrent participation in another clinical trial of prostate cancer treatment that would preclude study therapy or outcome measures
  • Concurrent prophylactic radiotherapy to prevent gynecomastia allowed

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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