A Randomized-Controlled Trial of Transcutaneous Oestrogen Patches Versus LHRH Agonists in Prostate Cancer


Condition: Anemia, Cardiovascular Complications, Hot Flashes, Osteoporosis, Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT00303784

Sponsor: University College, London

Phase: Phase 3

Eligibility:

  • Age: minimum N/A maximum 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

View trial on ClinicalTrials.gov


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