Prostate Cancer Clinical Trial
Official title:
Acitve Monitoring, Radical Prostatectomy, or Radiation Therapy in Treating Patients With Localized Prostate Cancer
Verified date | October 2011 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Radical prostatectomy is surgery to remove the entire prostate. Radiation therapy
uses high-energy x-rays or other types of radiation to kill tumor cells. Sometimes the tumor
may not need treatment until it progresses. In this case, active surveillance may be
sufficient. It is not yet known which treatment regimen is more effective for localized
prostate cancer.
PURPOSE: This randomized phase III trial is studying active surveillance to see how well it
works compared with radical prostatectomy or radiation therapy in treating patients with
localized prostate cancer.
Status | Active, not recruiting |
Enrollment | 2050 |
Est. completion date | |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 50 Years to 69 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed prostate cancer - Clinically localized disease - Stage T1-T2, NX, M0 tumor - Prostate-specific antigen (PSA) at the Prostate Check Clinic (PCC) in the range of 3.0-19.99 ng/mL - No skeletal metastases by isotope bone scan (if PCC PSA 10-19.99 ng/mL or Gleason score 8-10) - Registered with a participating general practice on the date of the PCC - Registration with another practice after study entry allowed PATIENT CHARACTERISTICS: - Life expectancy = 10 years - Fit for any of the three study treatments - No concurrent or past malignancies other than a small treated skin cancer - No serious cardiac or respiratory problems in the past 12 months, including any of the following: - Stroke - Myocardial infarction - Heart failure - Chronic obstructive pulmonary disease - Blood-borne infections allowed PRIOR CONCURRENT THERAPY: - No prior treatment for prostate malignancy - No prior kidney dialysis or transplantation - No bilateral hip replacement - No previous entry to this study at a prior general practice |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust | Birmingham | England |
United Kingdom | Southmead Hospital | Bristol | England |
United Kingdom | Addenbrooke's Hospital | Cambridge | England |
United Kingdom | University Hospital of Wales | Cardiff | Wales |
United Kingdom | Edinburgh Cancer Centre at Western General Hospital | Edinburgh | Scotland |
United Kingdom | Leeds Cancer Centre at St. James's University Hospital | Leeds | England |
United Kingdom | Leicester General Hospital | Leicester | England |
United Kingdom | Freeman Hospital | Newcastle-Upon-Tyne | England |
United Kingdom | Oxford Radcliffe Hospital | Oxford | England |
United Kingdom | University of Sheffield School of Medicine and Biomedical Sciences | Sheffield | England |
Lead Sponsor | Collaborator |
---|---|
Oxford University Hospitals NHS Trust |
United Kingdom,
Brindle LA, Oliver SE, Dedman D, Donovan JL, Neal DE, Hamdy FC, Lane JA, Peters TJ. Measuring the psychosocial impact of population-based prostate-specific antigen testing for prostate cancer in the UK. BJU Int. 2006 Oct;98(4):777-82. — View Citation
Collin SM, Metcalfe C, Donovan J, Lane JA, Davis M, Neal D, Hamdy F, Martin RM. Associations of lower urinary tract symptoms with prostate-specific antigen levels, and screen-detected localized and advanced prostate cancer: a case-control study nested wit — View Citation
Lane JA, Howson J, Donovan JL, Goepel JR, Dedman DJ, Down L, Turner EL, Neal DE, Hamdy FC. Detection of prostate cancer in unselected young men: prospective cohort nested within a randomised controlled trial. BMJ. 2007 Dec 1;335(7630):1139. Epub 2007 Nov — View Citation
Lewis SJ, Murad A, Chen L, Davey Smith G, Donovan J, Palmer T, Hamdy F, Neal D, Lane JA, Davis M, Cox A, Martin RM. Associations between an obesity related genetic variant (FTO rs9939609) and prostate cancer risk. PLoS One. 2010 Oct 19;5(10):e13485. doi: — View Citation
Macefield RC, Metcalfe C, Lane JA, Donovan JL, Avery KN, Blazeby JM, Down L, Neal DE, Hamdy FC, Vedhara K; ProtecT Study Group. Impact of prostate cancer testing: an evaluation of the emotional consequences of a negative biopsy result. Br J Cancer. 2010 A — View Citation
Mills N, Donovan JL, Wade J, Hamdy FC, Neal DE, Lane JA. Exploring treatment preferences facilitated recruitment to randomized controlled trials. J Clin Epidemiol. 2011 Oct;64(10):1127-36. doi: 10.1016/j.jclinepi.2010.12.017. Epub 2011 Apr 7. — View Citation
Rowlands MA, Holly JM, Gunnell D, Donovan J, Lane JA, Hamdy F, Neal DE, Oliver S, Smith GD, Martin RM. Circulating insulin-like growth factors and IGF-binding proteins in PSA-detected prostate cancer: the large case-control study ProtecT. Cancer Res. 2012 — View Citation
Rowlands MA, Holly JM, Gunnell D, Gilbert R, Donovan J, Lane JA, Marsden G, Collin SM, Hamdy F, Neal DE, Martin RM. The relation between adiposity throughout the life course and variation in IGFs and IGFBPs: evidence from the ProtecT (Prostate testing for — View Citation
Turner EL, Lane JA, Donovan JL, Davis MJ, Metcalfe C, Neal DE, Hamdy FC, Martin RM. Association of diabetes mellitus with prostate cancer: nested case-control study (Prostate testing for cancer and treatment study). Int J Cancer. 2011 Jan 15;128(2):440-6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival time as assessed after the first information appointment at 5 years,10 years, and then every 5 years thereafter | No | ||
Secondary | Disease progression as assessed by PSA levels, digital rectal examination, ultrasonography, biopsy, and bone scans at 6 months, 1 year, 5 years, and 10 years and then every 5 years thereafter | No | ||
Secondary | Treatment complications as assessed at 6 months, 1 year, 5 years, and 10 years and then every 5 years thereafter | Yes | ||
Secondary | General health status as assessed by validated instruments, including the SF-12, a subset of the SF-36, and EuroQol EQ-5D at 6 months, 1 year, 5 years, and 10 years and then every 5 years thereafter | No | ||
Secondary | Anxiety, depression, and psychological state as assessed by the Hospital Anxiety and Depression Scale, the Profile of Moods States, and the Impact of Events scale at 6 months, 1 year, 5 years, and 10 years and then every 5 years thereafter | No | ||
Secondary | Urinary symptoms as assessed by the ICSmaleSF questionnaire and the UCLA prostate cancer index at 6 months, 1 year, 5 years, and 10 years and then every 5 years thereafter | No | ||
Secondary | Quality of life as assessed at 6 months, 1 year, 5 years, and 10 years and then every 5 years thereafter | No | ||
Secondary | Sexual function as assessed by the ICSsex questionnaire and the UCLA prostate cancer index at 6 months, 1 year, 5 years, and 10 years and then every 5 years thereafter | No | ||
Secondary | Quality of life related to prostate cancer treatment as assessed by the UCLA prostate cancer index at 6 months, 1 year, 5 years, and 10 years and then every 5 years thereafter | No | ||
Secondary | Qualitative evaluation of outcome as assessed by in-depth interviews with samples of patients in each arm of the trial and also the preference groups at 6 months, 1 year, 5 years, and 10 years and then every 5 years thereafter | No | ||
Secondary | Resource use (NHS, social service, and personal) as assessed by routine hospital and primary care data sources with additional questions in clinical and participant questionnaires | No |
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