Status:
UNKNOWN
Prostate Adenocarcinoma TransCutaneous Hormones
Lead Sponsor:
University College, London
Collaborating Sponsors:
Medical Research Council
Conditions:
Anemia
Cardiovascular Complications
Eligibility:
MALE
Up to 120 years
Phase:
PHASE3
Brief Summary
RATIONALE: The increasingly prolonged and extended use of androgen deprivation therapy (ADT) in the treatment of prostate cancer, usually achieved through the administration of LHRH agonists, has rais...
Detailed Description
OBJECTIVES: Primary * Compare the progression-free survival and overall survival of patients with locally advanced or metastatic prostate cancer treated with transcutaneous estrogen patches vs lutei...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
2200 Patients enrolled
Trial Details
Trial ID
NCT00303784
Start Date
March 1 2006
End Date
August 1 2021
Last Update
November 27 2020
Active Locations (32)
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1
Queen's Hospital
Burton-on-Trent, England, United Kingdom, DE13 0RB
2
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
3
Walsgrave Hospital
Coventry, England, United Kingdom, CV2 2DX
4
Mid Cheshire Hospitals Trust- Leighton Hopsital
Crewe, England, United Kingdom, CW1 4QJ