Prostate Adenocarcinoma TransCutaneous Hormones (PATCH)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Anemia Cardiovascular Complications Hot Flashes Osteoporosis Prostate Cancer | Drug: Goserelin Drug: Estradiol | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | A Randomized-Controlled Trial of Transcutaneous Oestrogen Patches Versus LHRH Agonists in Prostate Cancer |
- Progression-Free Survival [ Time Frame: Up to 180 months ]
- Overall Survival [ Time Frame: Up to 180 months ]
- Hormone activity by castrate levels of hormones [ Time Frame: Up to 180 months ]
- Other toxicity [ Time Frame: Up to 180 months ]
- Cardiovascular morbidity [ Time Frame: Up to 180 months ]
- Cardiovascular mortality [ Time Frame: Up to 180 months ]
- Quality of Life [ Time Frame: Up to 24 months ]
| Estimated Enrollment: | 2200 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | August 2021 |
| Estimated Primary Completion Date: | August 2021 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
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Active Comparator: LHRH agonists
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.
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Drug: Goserelin
3.6mg implant, in pre-filled syringe
Other Name: Zoladex
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Experimental: Oestrogen Patches
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).
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Drug: Estradiol
Each patch contains 3 mg of estradiol hemihydrate in a patch size of 30 cm2, releasing 100 micrograms of estradiol per 24 hours.
Other Name: FemSeven
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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 luteinizing hormone-releasing hormone analogues.
Secondary
- Compare the cardiovascular system-related morbidity and mortality in patients treated with these regimens
- Compare the activity of these treatments, in terms of castrate level of hormones, failure-free survival, and biochemical failure, in these patients.
- Compare other toxicities, including osteoporosis, hot flushes, gynecomastia, and anemia, in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms at 1(control):1 (patch) ratio.
- Arm I (control): Patients receive luteinizing hormone-releasing hormone agonists as per local practice in the absence of unacceptable toxicity.
- Arm II (patch): Patients receive 4 transcutaneous estrogen patches, changing twice weekly for 4 weeks. Patients' testosterone levels are measured at week 4. Patients whose testosterone level is > 1.7 nmol/L continue to receive patch as before and have their testosterone level measured every 2 weeks. Patients whose testosterone level is < 1.7 nmol/L at week 4 or any other point receive 3 transcutaneous estrogen patches changed twice weekly in the absence of unacceptable toxicity.
Quality of life is assessed at baseline; at weeks 4, 8, and 12; every 3 months for 24 months.
After completion of study treatment, patients are followed periodically.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 2200 patients will be accrued for this study.
Eligibility
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| Ages Eligible for Study: | up to 120 Years (Child, Adult, Senior) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Must meet 1 of the following criteria:
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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
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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
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- 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
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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
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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
Contacts and Locations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00303784
| United Kingdom | |
| Queen's Hospital | Recruiting |
| Burton-upon-Trent, England, United Kingdom, DE13 0RB | |
| Contact: Contact Person 44-1283-566-333 | |
| Addenbrooke's Hospital | Recruiting |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Contact: Helen Patterson, MD 44-122324-5151 ext. 2523 and 2 | |
| Walsgrave Hospital | Recruiting |
| Coventry, England, United Kingdom, CV2 2DX | |
| Contact: Contact Person 44-24-7660-2020 | |
| Mid Cheshire Hospitals Trust- Leighton Hopsital | Recruiting |
| Crewe, England, United Kingdom, CW1 4QJ | |
| Contact: J. P. Logue, MD 44-1270-255-141 | |
| Mayday University Hospital | Recruiting |
| Croydon, England, United Kingdom | |
| Contact: Robert A. Huddart, MD 44-20-8401-3000 | |
| Derbyshire Royal Infirmary | Recruiting |
| Derby, England, United Kingdom, DE1 2QY | |
| Contact: Contact Person 44-1332-347-141 ext. 2407 | |
| Castle Hill Hospital | Recruiting |
| East Yorkshire, England, United Kingdom, HU16 5JQ | |
| Contact: Contact Person 44-1482-875-875 | |
| Royal Devon and Exeter Hospital | Recruiting |
| Exeter, England, United Kingdom, EX2 5DW | |
| Contact: Denise J. Sheehan, MD 44-1392-411-611 | |
| Grantham and District Hospital | Recruiting |
| Grantham, Lincolnshire, England, United Kingdom, NG31 8DG | |
| Contact: P. Daruwala 44-1476-565-232 | |
| Ipswich Hospital | Recruiting |
| Ipswich, England, United Kingdom, IP4 5PD | |
| Contact: Christopher Scrase, MD 44-147-370-4177 | |
| Kidderminster Hospital | Recruiting |
| Kidderminster Worcestershire, England, United Kingdom, DY11 6RJ | |
| Contact: Contact Person 44-190-576-0635 | |
| Leeds Cancer Centre at St. James's University Hospital | Recruiting |
| Leeds, England, United Kingdom, LS9 7TF | |
| Contact: Contact Person 44-113-206-6400 | |
| St. Mary's Hospital | Recruiting |
| London, England, United Kingdom, W2 1NY | |
| Contact: Simon Stewart, MD 44-207-886-1132 s.stewart@imperial.ac.uk | |
| Charing Cross Hospital | Recruiting |
| London, England, United Kingdom, W6 8RF | |
| Contact: Paul D. Abel 44-20-8383-2268 | |
| Maidstone Hospital | Recruiting |
| Maidstone, England, United Kingdom, ME16 9QQ | |
| Contact: Sharon Beesley 44-1622-729-000 | |
| James Cook University Hospital | Recruiting |
| Middlesbrough, England, United Kingdom, TS4 3BW | |
| Contact: Contact Person 44-1642-850-850 | |
| Kings Mill Hospital | Recruiting |
| Nottinghamshire, England, United Kingdom, NG17 4JL | |
| Contact: Contact Person 44-162-362-2515 | |
| Nottingham City Hospital | Recruiting |
| Nottingham, England, United Kingdom, NG5 1PB | |
| Contact: Santhanam Sundar 44-115-969-1169 santhanam.sundar@nuh.nhs.uk | |
| George Eliot Hospital | Recruiting |
| Nuneaton, England, United Kingdom, CV10 7DJ | |
| Contact: Contact Person 44-024-7635-1351 | |
| Alexandra Healthcare NHS | Recruiting |
| Redditch, Worcestershire, England, United Kingdom, B98 7UB | |
| Contact: Contact Person 44-015-2750-3030 | |
| Hope Hospital | Recruiting |
| Salford, England, United Kingdom, M6 8HD | |
| Contact: Noel Clarke 44-161-206-5568 | |
| Scarborough General Hospital | Recruiting |
| Scarborough, England, United Kingdom, YO12 6QL | |
| Contact: Andrew Robertson 44-1723-368-111 | |
| Stepping Hill Hospital | Recruiting |
| Stockport, England, United Kingdom, SK2 7JE | |
| Contact: Contact Person 44-161-483-1010 | |
| Hillingdon Hospital | Recruiting |
| Uxbridge, England, United Kingdom, UB8 3NN | |
| Contact: Alvan J. Pope 44-1895-238-282 | |
| Walsall Manor Hospital | Recruiting |
| Walsall, England, United Kingdom, WS2 9PS | |
| Contact: Contact Person 44-1922-721-172 | |
| Warwick Hospital | Recruiting |
| Warwick, England, United Kingdom, CV34 5BW | |
| Contact: Contact Person 44-1926 495-321 | |
| Worthing Hospital | Recruiting |
| Worthing, England, United Kingdom, BN11 2DH | |
| Contact: Ralph Beard 44-1903-205-111 ext. 5559 | |
| Yeovil District Hospital | Recruiting |
| Yeovil, England, United Kingdom, BA21 4AT | |
| Contact: Chris Parker 44-1935-475-122 | |
| Ayr Hospital | Recruiting |
| Ayr, Scotland, United Kingdom, KA6 6DX | |
| Contact: Contact Person 44-1292-610-555 | |
| Beatson West of Scotland Cancer Centre | Recruiting |
| Glasgow, Scotland, United Kingdom, G12 0YN | |
| Contact: Contact Person 44-141-211-2123 | |
| Velindre Cancer Center at Velindre Hospital | Recruiting |
| Cardiff, Wales, United Kingdom, CF14 2TL | |
| Contact: J. Lester, MD 44-29-2031-6292 | |
| University Hospital of Wales | Recruiting |
| Cardiff, Wales, United Kingdom, CF14 4XW | |
| Contact: Howard Kynaston 44-2920-745-094 | |
| Study Chair: | Paul D. Abel | Charing Cross Hospital |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT00303784 History of Changes |
| Other Study ID Numbers: |
CDR0000455583 MRC-PATCH EU-205106 MRC-PR09 ISRCTN70406718 EUDRACT-2005-001030-33 |
| First Submitted: | March 15, 2006 |
| First Posted: | March 17, 2006 |
| Last Update Posted: | October 27, 2016 |
| Last Verified: | October 2016 |
Keywords provided by Imperial College London:
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hot flashes anemia osteoporosis cardiovascular complications |
recurrent prostate cancer stage III prostate cancer stage IV prostate cancer adenocarcinoma of the prostate |
Additional relevant MeSH terms:
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Prostatic Neoplasms Adenocarcinoma Osteoporosis Hot Flashes Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Bone Diseases, Metabolic Bone Diseases |
Musculoskeletal Diseases Metabolic Diseases Signs and Symptoms Estradiol Polyestradiol phosphate Estrogens Estradiol 3-benzoate Estradiol 17 beta-cypionate Estradiol valerate Goserelin Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Contraceptive Agents Reproductive Control Agents |