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| [ Print-friendly version ] |
| Prostate Adenocarcinoma: TransCutaneous Hormones versus luteinising hormone-releasing hormone (LHRH) analogues |
| ISRCTN | ISRCTN70406718 |
| ClinicalTrials.gov identifier | NCT00303784 |
| Public title | Prostate Adenocarcinoma: TransCutaneous Hormones versus luteinising hormone-releasing hormone (LHRH) analogues |
| Scientific title | A randomised controlled trial of transcutaneous oestrogen patches versus luteinising hormone-releasing hormone (LHRH) analogues in prostate cancer |
| Acronym | PATCH |
| Serial number at source | MRC PATCH v2.0 |
| Study hypothesis |
The primary objective of this study is to confirm that oestrogen patches are a safe and efficacious therapy for patients with locally advanced and metastatic prostate cancer. Transcutaneous oestrogen avoids first-pass hepatic metabolism and therefore is not expected to be associated with the same level of cardiovascular system (CVS) toxicity as oral oestrogen. Patients with locally advanced or metastatic prostate cancer will be randomised between transcutaneous oestrogen patches and luteinising hormone-releasing hormone (LHRH) analogues in a 2:1 ratio in order to maximise experience with the patches. The primary endpoint of the study is CVS toxicity.
For a summary of a systematic review on the use of parenteral oestrogens in prostate cancer undertaken to inform the design of this study please see Appendix H or access the following link: http://www.york.ac.uk/inst/crd/pdf/parentoestrogen.pdf). Please note that as of 16/02/2009 this record was updated to include an amended end date; the initial end date at the time of registration was: Initial anticipated end date: 01/09/2010 As of 15/02/2011 the end date has again been updated from 01/06/2009 to 30/09/2013. |
| Lay summary | http://www.cancerhelp.org.uk/trials/a-trial-looking-at-hormone-patches-for-prostate-cancer |
| Ethics approval | Added 16/02/2009: Leeds (East) REC on 23/11/2005 (ref: 05/Q1206/168) |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Prostate cancer |
| Participants - inclusion criteria |
Newly diagnosed patients with one of the following:
1. Stage T3/4 NX M0 histologically confirmed prostate adenocarcinoma with prostate specific antigen (PSA) greater than or equal to 20 ng/ml or Gleason sum score greater than or equal to 6 2. Stage Tany N+ M0 or Tany Nany M+ histologically confirmed prostate adenocarcinoma 3. Multiple sclerotic bone metastases with a PSA greater than or equal to 50 ng/ml without histological confirmation OR Patients with histologically confirmed prostate adenocarcinoma previously treated; with radical surgery or radiotherapy who are now relapsing with one of: 1. PSA greater than or equal to 4 ng/ml and rising with doubling time less than 6 months 2. PSA greater than or equal to 20 ng/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. For all patients: 1. Intention to treat with long-term androgen deprivation therapy (ADT) 2. Fit for all protocol treatment and follow-up, World Health Organization (WHO) performance status 0 - 2 3. Have completed the appropriate investigations prior to randomisation 4. Normal testosterone level prior to hormone treatment 5. Written informed consent 6. Willing and expected to comply with follow-up schedule |
| Participants - exclusion criteria |
1. Prior systemic therapy for locally advanced or metastatic prostate cancer
2. Any other previous or current malignant disease or CVS disease which, in the judgement of the responsible physician, is likely to interfere with PATCH treatment or assessment. 3. Cardiovascular exclusions: 3.1. Any history of cerebral ischaemia (e.g. stroke or transient ischaemic attack [TIA]) 3.2. Any history of deep vein thrombosis (DVT) or pulmonary embolism (PE) confirmed radiologically 3.3. History of myocardial infarction 3.3.1. Within the last 6 months 3.3.2. Greater than 6 months with evidence of q-wave anterior infarct on electrocardiogram (ECG) (right lead [RL]) 3.4. Unstable angina (typical cardiac chest pain at rest lasting more than 15 minutes) within the last year 3.5. 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 3.6. 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 3.7. Blood pressure (BP) greater than or equal to 160/100 (if either systolic or diastolic BP greater than these values then the patient is not eligible) 3.8. Pulmonary oedema on chest x-ray (CXR) Patients that have a history of ischaemic heart disease or heart failure are required to have an Echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA). Patients with left ventricular ejection fraction less than 40% will be excluded. |
| Anticipated start date | 01/09/2005 |
| Anticipated end date | 30/09/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 200 |
| Interventions | LHRH analogues versus transdermal oestrogen patches. |
| Primary outcome measure(s) |
CVS morbidity and mortality. Criteria for differing CVS events will be defined as follows:
1. Heart Failure: New clinical signs/symptoms and/or CXR changes of heart failure requiring the use or change of diuretics and/or angiotensin-converting enzyme inhibitors 2. Ischaemic Heart Disease: Myocardial infarction diagnosed by at least two of the following: 2.1. Typical cardiac chest pain for 30 minutes or more 2.2. Cardiac enzymes greater than 2 times upper limit of normal 2.3. Typical ECG changes: 2.3.1. Unstable angina (typical cardiac chest pain at rest) for greater than 15 minutes 2.3.2. Stable angina-exercise induced pain with increasing frequency of attacks lasting greater than 15 minutes or a long-lasting attack (greater than 15 minutes) with newly developed ST-changes or T wave inversion 3. Cerebral ischaemic event: cerebral infarction seen on computerised tomography (CT) or magnetic resonance imaging (MRI). Transient ischaemic attacks with clear neurological symptoms from regions of the internal carotid or vertebral arteries. 4. Intermittent Claudication: severe intermittent claudication at a maximum walking distance of 200 metres 5. Venous thromboembolism: thromboses to be confirmed radiologically. Pulmonary embolism to be confirmed by means of ventilation/perfusion scans or angiography. 6. Death attributed to any of the above All cardiovascular events will be reviewed by two blinded reviewers. |
| Secondary outcome measure(s) |
1. Activity (castrate levels of hormones): luteinishing hormone (LH) and follicle-stimulating hormone (FSH) will be measured pre-randomisation and then at 12 weeks, 6 months and then at 1 and 2 years post randomisation. Testosterone will be measured pre-randomisation and then at 4 and 12 weeks, 6 months and then at 1 and 2 years post randomisation to confirm that castrate levels are achieved and maintained. Adjustments to the dose of the patches will be made if necessary. Sex hormone binding globulin (SHBG) will be measured at pre-randomisation and then at 4 and 12 weeks, 6 months and then at 1 year post randomisation. Oestrone and oestradiol levels will be measured at baseline and at 4, 8 and 12 weeks, 6 months and then at 2 years. Fasting glucose, insulin and lipids will be measured at baseline, 6 months and 1 and 2 years. Urinary metabolites (hydroxyproline) will also be measured at baseline, 1 and 2 years. Clotting studies will include measurement of INR, APTT, Von Willebrand Factor, fibrinogen, and platelets at baseline, 6 months and 1 year.
2. Failure-free survival (FFS) (including biochemical failure) 3. Other toxicity (osteoporosis, hot flushes, gynaecomastia, anaemia): bone scans, CXR and CT/MRI scans of abdomen, pelvis and chest will be performed as clinically appropriate. Toxicity resulting in the patient stopping treatment will be measured, as will grade 3 or 4 toxicity at pre-specified time points using the NCI Common Toxicity Criteria (CTCv3). 4. Quality of life (QoL): QoL will be measured using patient-completed questionnaires (EORTC QLQ-C30 and PR25 which is prostate specific). |
| Sources of funding |
1. Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) (ref: C17093/A5343)
2. Medical Research Council (MRC) (UK) |
| Trial website | |
| Publications | 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18422771 |
| Contact name | Mr Paul Abel |
| Address |
Block ‘B’, Department of Surgery
Hammersmith Hospital Du Cane Road |
| City/town | London |
| Zip/Postcode | W12 0NN |
| Country | United Kingdom |
| Tel | +44 (0)20 8383 2268 |
| Fax | +44 (0)20 8383 2431 |
| p.abel@imperial.ac.uk | |
| Sponsor | Imperial College London (UK) |
| Address |
c/o Mr Gary Roper
Imperial College London Faculty of Medicine Level 2, Faculty Building South Kensington Campus |
| City/town | London |
| Zip/Postcode | SW7 2AZ |
| Country | United Kingdom |
| Sponsor website: | http:\\www.ic.ac.uk |
| Date applied | 14/07/2005 |
| Last edited | 02/08/2011 |
| Date ISRCTN assigned | 12/09/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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