Prostate Cancer Clinical Trial
— PATCHOfficial title:
A Randomized-Controlled Trial of Transcutaneous Oestrogen Patches Versus LHRH Agonists in Prostate Cancer
Verified date | November 2020 |
Source | University College, London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 raised concerns about long-term toxicities, in particular osteoporosis and adverse metabolic changes which may be associated with type II diabetes and increased cardiovascular risk. An alternative approach is to investigate other methods of ADT. Oral oestrogen has been shown to be as effective as LHRH and surgical orchidectomy in achieving castrate levels of testosterone and has equivalent or improved prostate cancer outcomes but is not used routinely as first-line therapy because of the risk of cardiovascular system (CVS) complications. The CVS complications have been attributed to first-pass hepatic metabolism. Administering oestrogen parenterally avoids the entero-hepatic circulation and so is expected to mitigate the risk of CVS toxicity whilst still effectively suppressing testosterone to castrate levels. This hypothesis has been supported by results from the early stages of this trial which have provided sufficient indication of the safety and efficacy of the patches to warrant further investigation of the treatment in this setting, as recommended by the IDMC.. PURPOSE: This randomized phase III trial is studying how well the estrogen skin patch works compared with luteinizing hormone-releasing hormone agonist injections in treating patients with locally advanced or metastatic prostate cancer.
Status | Recruiting |
Enrollment | 2200 |
Est. completion date | August 2021 |
Est. primary completion date | August 2021 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A to 120 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Ayr Hospital | Ayr | Scotland |
United Kingdom | Queen's Hospital | Burton-upon-Trent | England |
United Kingdom | Addenbrooke's Hospital | Cambridge | England |
United Kingdom | University Hospital of Wales | Cardiff | Wales |
United Kingdom | Velindre Cancer Center at Velindre Hospital | Cardiff | Wales |
United Kingdom | Walsgrave Hospital | Coventry | England |
United Kingdom | Mid Cheshire Hospitals Trust- Leighton Hopsital | Crewe | England |
United Kingdom | Mayday University Hospital | Croydon | England |
United Kingdom | Derbyshire Royal Infirmary | Derby | England |
United Kingdom | Castle Hill Hospital | East Yorkshire | England |
United Kingdom | Royal Devon and Exeter Hospital | Exeter | England |
United Kingdom | Beatson West of Scotland Cancer Centre | Glasgow | Scotland |
United Kingdom | Grantham and District Hospital | Grantham, Lincolnshire | England |
United Kingdom | Ipswich Hospital | Ipswich | England |
United Kingdom | Kidderminster Hospital | Kidderminster Worcestershire | England |
United Kingdom | Leeds Cancer Centre at St. James's University Hospital | Leeds | England |
United Kingdom | Charing Cross Hospital | London | England |
United Kingdom | St. Mary's Hospital | London | England |
United Kingdom | Maidstone Hospital | Maidstone | England |
United Kingdom | James Cook University Hospital | Middlesbrough | England |
United Kingdom | Nottingham City Hospital | Nottingham | England |
United Kingdom | Kings Mill Hospital | Nottinghamshire | England |
United Kingdom | George Eliot Hospital | Nuneaton | England |
United Kingdom | Alexandra Healthcare NHS | Redditch, Worcestershire | England |
United Kingdom | Hope Hospital | Salford | England |
United Kingdom | Scarborough General Hospital | Scarborough | England |
United Kingdom | Stepping Hill Hospital | Stockport | England |
United Kingdom | Hillingdon Hospital | Uxbridge | England |
United Kingdom | Walsall Manor Hospital | Walsall | England |
United Kingdom | Warwick Hospital | Warwick | England |
United Kingdom | Worthing Hospital | Worthing | England |
United Kingdom | Yeovil District Hospital | Yeovil | England |
Lead Sponsor | Collaborator |
---|---|
University College, London | Medical Research Council |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-Free Survival | Up to 180 months | ||
Primary | Overall Survival | Up to 180 months | ||
Secondary | Hormone activity by castrate levels of hormones | Up to 180 months | ||
Secondary | Other toxicity | Up to 180 months | ||
Secondary | Cardiovascular morbidity | Up to 180 months | ||
Secondary | Cardiovascular mortality | Up to 180 months | ||
Secondary | Quality of Life | will be measured using patient-completed questionnaires, EORTC QLQ-C30 and PR25 which is prostate specific | Up to 24 months |
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