Prostate Adenocarcinoma TransCutaneous Hormones (PATCH)
Anemia, Cardiovascular Complications, Hot Flashes
About this trial
This is an interventional treatment trial for Anemia focused on measuring hot flashes, anemia, osteoporosis, cardiovascular complications, recurrent prostate cancer, stage III prostate cancer, stage IV prostate cancer, adenocarcinoma of the prostate
Eligibility Criteria
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
Sites / Locations
- Queen's HospitalRecruiting
- Addenbrooke's HospitalRecruiting
- Walsgrave HospitalRecruiting
- Mid Cheshire Hospitals Trust- Leighton HopsitalRecruiting
- Mayday University HospitalRecruiting
- Derbyshire Royal InfirmaryRecruiting
- Castle Hill HospitalRecruiting
- Royal Devon and Exeter HospitalRecruiting
- Grantham and District HospitalRecruiting
- Ipswich HospitalRecruiting
- Kidderminster HospitalRecruiting
- Leeds Cancer Centre at St. James's University HospitalRecruiting
- St. Mary's HospitalRecruiting
- Charing Cross HospitalRecruiting
- Maidstone HospitalRecruiting
- James Cook University HospitalRecruiting
- Kings Mill HospitalRecruiting
- Nottingham City HospitalRecruiting
- George Eliot HospitalRecruiting
- Alexandra Healthcare NHSRecruiting
- Hope HospitalRecruiting
- Scarborough General HospitalRecruiting
- Stepping Hill HospitalRecruiting
- Hillingdon HospitalRecruiting
- Walsall Manor HospitalRecruiting
- Warwick HospitalRecruiting
- Worthing HospitalRecruiting
- Yeovil District HospitalRecruiting
- Ayr HospitalRecruiting
- Beatson West of Scotland Cancer CentreRecruiting
- Velindre Cancer Center at Velindre HospitalRecruiting
- University Hospital of WalesRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
LHRH agonists
Oestrogen Patches
Patients randomised to the control arm will receive continuous treatment with LHRH agonists as per local practice. Treatment should continue for at least 3 years. LHRH antagonists, such as degarelix, are not allowed on the trial. The recommended "anti-flare" medication is bicalutamide and should be prescribed according to local practice. Control arm medication should be obtained from the hospital pharmacy or GP as per local practice.
Patients randomised to the investigational arm will receive transcutaneous oestrogen patches (100 micrograms/24 hours). Treatment should be planned to continue for at least 3 years. For patients prescribed bicalutamide or flutamide prior to randomisation, this treatment should be discontinued before treatment with the patches can commence (no washout period is needed).