Active Surveillance, Radical Prostatectomy, or Radiation Therapy in Treating Patients With Localized Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00632983
First received: March 8, 2008
Last updated: April 13, 2012
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Anxiety Disorder
Long-term Effects Secondary to Cancer Therapy in Adults
Prostate Cancer
Sexual Dysfunction
Urinary Complications
Drug: cyproterone acetate
Drug: releasing hormone agonist therapy
Other: active surveillance
Other: medical chart review
Other: questionnaire administration
Procedure: assessment of therapy complications
Procedure: quality-of-life assessment
Procedure: therapeutic conventional surgery
Procedure: therapeutic lymphadenectomy
Radiation: 3-dimensional conformal radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Acitve Monitoring, Radical Prostatectomy, or Radiation Therapy in Treating Patients With Localized Prostate Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Survival time as assessed after the first information appointment at 5 years,10 years, and then every 5 years thereafter [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Designated as safety issue: No ]
  • Treatment complications as assessed at 6 months, 1 year, 5 years, and 10 years and then every 5 years thereafter [ Designated as safety issue: Yes ]
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Quality of life as assessed at 6 months, 1 year, 5 years, and 10 years and then every 5 years thereafter [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]

Estimated Enrollment: 2050
Study Start Date: June 2001
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To assess survival of patients with localized prostate cancer at 10 years and 15 years after treatment.
  • To investigate 5-year survival, disease progression (i.e., biochemical and clinical), treatment complications, and lower urinary tract symptoms in these patients.
  • To investigate the psychosocial impact of case-finding and treatment on these patients, including generic health status, quality of life, and sexual function.
  • To estimate the resource use and costs of case-finding, treatment, and follow-up.
  • To compare costs and outcomes of treatment in terms of survival and health-related quality of life.
  • To collect samples suitable for basic science research (ProMPT study).

OUTLINE: This is a multicenter study. Patients are stratified by age (50-55 vs 56-59 vs 60-65 vs 66-69 years), Gleason score (2-4 vs 5-7 vs 8-10), and average result of Prostate Check Clinic and first biopsy prostate-specific antigen (PSA) tests (< 6 vs 6-9.9 vs ≥ 10 ng/mL). Patients are either randomized to or select 1 of 3 treatment arms.

  • Arm I (active monitoring): Patients undergo active monitoring of their disease. Patients are seen by the research nurse 3 months after randomization to fine disease management plan. As part of this process, patients, together with the urologist or research nurse, develop a management plan that includes repeat PSA testing (every 3 months in the first year and then every 6 months thereafter) to detect biochemical progression. Patients also undergo an annual review appointment with an opportunity for digital rectal examination, if indicated (e.g., rise in PSA or new symptoms). PSA levels are monitored and tests repeated as needed. Additional review appointment is arranged with the study urologist for confirmed rising PSA level, apparent symptoms of spreading disease, or concern about the PSA levels. At the review appointment, the study urologist discusses issues raised and current options, including remaining on active monitoring, undergoing re-staging of the cancer, or receiving other treatments, as appropriate.
  • Arm II (radical prostatectomy): Patients undergo radical prostatectomy (RP) within 2-12 weeks after study entry. Patients undergo RP and pelvic lymphadenectomy with or without frozen section biopsy of the pelvic lymph nodes prior to prostatectomy. Patients with positive surgical margins may be recommended for adjuvant treatment at the surgeon's discretion.
  • Arm III (radical conformal radiotherapy): Patients undergo 3-dimensional conformal radiotherapy for 7.4 weeks (37 fractions). Patients receive neoadjuvant androgen-deprivation therapy comprising luteinizing hormone-releasing hormone (LHRH) agonists once every 4 weeks, beginning prior to the start of radiotherapy and continuing for at least 3-6 months (at least until completion of radiotherapy). Patients also receive cyproterone acetate or equivalent alternative beginning 1 week prior to the first LHRH agonist injection and continuing for at least 3 weeks.

After completion of surgery or radiotherapy, patients are followed according to National Health Service (UK) guidelines every 6-12 months.

All patients complete questionnaires at baseline and periodically during study to provide socio-demographic information (e.g., age, socio-economic status, and ethnicity), as well as clinical information on past or current urinary symptoms, previous PSA tests, anxiety and depression, sexual function, general health status, treatment-related quality of life, and environmental exposures. Resource use and cost-utility analysis is also performed.

  Eligibility

Ages Eligible for Study:   50 Years to 69 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632983

Locations
United Kingdom
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom, B15 2TH
Southmead Hospital
Bristol, England, United Kingdom, BS10 5NB
Addenbrooke's Hospital
Cambridge, England, United Kingdom, BC2 2QQ
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Leicester General Hospital
Leicester, England, United Kingdom, LE5 4PW
Freeman Hospital
Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
University of Sheffield School of Medicine and Biomedical Sciences
Sheffield, England, United Kingdom, S10 2TN
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 2XU
University Hospital of Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Investigators
Principal Investigator: Freddie C. Hamdy, MD Oxford University Hospitals NHS Trust
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00632983     History of Changes
Other Study ID Numbers: CDR0000584897, SHEFF-PROTECT, ISRCTN20141297, EU-20802, SHEFF-HTA-96/20/99, RADCLIFFE-PROTECT
Study First Received: March 8, 2008
Last Updated: April 13, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
long-term effects secondary to cancer therapy in adults
anxiety disorder
sexual dysfunction
urinary complications
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Anxiety Disorders
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Mental Disorders
Cyproterone
Cyproterone Acetate
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on September 18, 2014