Newly diagnosed or relapsing patients with locally advanced or metastatic prostate cancer
Conditions
Interventions
Trade Name: FemSeven 100
Product Name: FemSeven 100
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: ESTRADIOL HEMIHYDRATE
CAS Number: 35380-71-3
Concentration unit: µg microgram(s)
Concent
Sponsors
University College London
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Newly Diagnosed Patients with at least one of: (i)Stage T3/4 NO or NX M0 histologically confirmed prostate adenocarcinoma with either PSA=20ng/ml or Gleason sum score =6 (ii)Stage Tany N+ M0 or Tany Nany M+ histologically confirmed prostate adenocarcinoma (iii)Multiple sclerotic bone metastases with a PSA=50ng/ml without histological confirmation of prostate cancer OR Patients with histologically confirmed prostate adenocarcinomapreviously treated with radical surgery and/or radiotherapy who are now relapsing with at least one of: (i)PSA =4ng/ml and rising with doubling time less than 6 months (ii)PSA =20ng/ml (iii)Documented evidence of metastatic disease with PSA>4ng/ml Note: Prior hormone therapy for localised disease must have been completed at least 12 months previously and have been no longer than 12 months in duration. It can have been given as adjuvant or neoadjuvant therapy. Patients who have started Bicalutamide or Flutamide (up to 8 weeks prior to date of randomisation) are eligible. Patients who have started Cyproterone Acetate prior to randomisation are not eligible. AND For all patients: (i)Intention to treat with long-term androgen deprivation therapy (> 3 years). (ii)Fit for all protocol treatment and follow-up, WHO performance status 0-2 (see protocol v12.0 Appendix A) (iii)Should have completed the appropriate investigations prior to randomisation (see protocol v12.0 section 4.4) (iv)Written informed consent (v)Willing and expected to comply with protocol (vi)For newly diagnosed N0M0 patients only - Intention to treat with radical radiotherapy (unless there is a specific contraindication; exemption can be sought in advance of consent after discussion with the PATCH Trial Manager). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2500
Exclusion criteria
Exclusion criteria: (i)Prior systemic therapy for locally advanced or metastatic prostate cancer except as listed in protocol section 4.2. (ii)Any other previous or current malignant disease or Cardiovascular disease which is thought likely to compromise the patient’s ability to tolerate therapy or affect assessment. (iii) Cardiovascular exclusions: a. Any history of cerebral ischaemia (e.g. Stroke or TIA) within 2 years of randomisation b. Any history of deep vein thrombosis or pulmonary embolism confirmed radiologically or a known thrombophilic disorder (e.g. Protein C, protein S, or antithrombin deficiency) c. History of myocardial infarction/acute coronary syndrome (i)within the last 6 months (ii)greater than 6 months with evidence of q-wave anterior infarct on ECG*1 and 2 d. Unstable angina (typical cardiac chest pain at rest lasting more than 15 minutes) within the last year *2. e. Angina that occurs on walking 100 metres on the level or after climbing one flight of stairs at a normal pace and in normal condition, or angina that causes marked limitation of ordinary physical activity or occurs at rest*2. f. Heart failure: If patients have symptoms such as shortness of breath or oedema that are attributed to heart failure and this causes marked limitation of activity and/or they are comfortable only at rest then they should be excluded from the study*2. g. Pulmonary oedema on CXR. (iv) Known porphyria. *1 If assistance with interpretation of ECG is required and not available locally please fax ECG to PATCH Trial Manager on 020 7670 4818. Please allow two working days for a response. Any other cardiac queries can also be forwarded to the PATCH Trial Manager by telephone or email (and will be directed to the PATCH Trial Cardiologist). *2 Patients that have a history of ischaemic heart disease or heart failure are required to have an ECHO or MUGA prior to randomisation. Patients with left ventricular ejection fraction =40% will be excluded from participating in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The PATCH trial is a randomised study evaluating a novel approach (transdermal oestrogens) for the treatment of locally advanced and metastatic prostate cancer. The primary objective of the trial is to confirm that transdermal oestrogen is a safe and efficacious therapy for patients with locally advanced and metastatic prostate cancer. The final phase III evaluation of efficacy will test the hypothesis that patches are non-inferior to standard androgen deprivation therapy in terms of overall survival and progression-free survival. ;Secondary Objective: The secondary outcome measures are metastasis-free prostate cancer-specific survival (for M0 patients only), cardiovascular morbidity and mortality, cardiovascular risk factors (including glucose and lipids), hormone levels (oestrogen, testosterone, PSA), toxicity, and quality of life.;Primary end point(s): Primary outcomes: - Overall survival - Progression Free Survival ;Timepoint(s) of evaluation of this end point: The co-primary outcomes, overall survival and progression free survival, will be evaluated at the final phase III efficacy analyses. The final phase III efficacy analysis will be performed when around 565 deaths and 815 progression free survival events have been observed in the control arm. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes: - Metastasis-free prostate cancer-specific survival (for M0 patients only) - Cardiovascular morbidity and mortality - Cardiovascular risk factors (including glucose and lipids) - Hormone levels (oestradiol, testosterone, PSA) - Toxicity (specifically osteoporosis, hot flushes, gynaecomastia, anaemia) - Quality of life | — |
Countries
United Kingdom
Contacts
Public ContactMelanie Weiss
MRC CTU at UCL
Outcome results
None listed