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Prostate Testing for Cancer and Treatment (ProtecT)

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ClinicalTrials.gov Identifier: NCT02044172
Recruitment Status : Active, not recruiting
First Posted : January 23, 2014
Last Update Posted : January 25, 2018
Sponsor:
Collaborator:
University of Bristol
Information provided by (Responsible Party):
University of Oxford

January 21, 2014
January 23, 2014
January 25, 2018
June 1, 2001
June 30, 2021   (Final data collection date for primary outcome measure)
Disease specific mortality [ Time Frame: Median 10 years follow up ]
Same as current
Complete list of historical versions of study NCT02044172 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: Median 10 years ]
  • Disease progression [ Time Frame: Median 10 years ]
    Metastases
  • Treatment complications [ Time Frame: Median 10 years ]
  • General health status [ Time Frame: Median 10 years ]
  • Psychological state [ Time Frame: Median 10 years ]
  • Symptoms [ Time Frame: Median 10 years ]
  • Sexual function [ Time Frame: Median 10 years ]
  • Resource use [ Time Frame: Median 10 years ]
Same as current
Not Provided
Not Provided
 
Prostate Testing for Cancer and Treatment
The ProtecT Trial - Evaluating the Effectiveness of Treatments for Clinically Localised Prostate Cancer

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 monitoring to see how well it works compared with radical prostatectomy or radiation therapy in treating patients with localized prostate cancer.

OBJECTIVES:

  • To assess survival of patients with localized prostate cancer at 10 years and 15 years after treatment.
  • To investigate disease progression (i.e., biochemical and clinical), treatment complications, and lower urinary tract symptoms in these patients.
  • To investigate the psychosocial impact of cancer detection and treatment on these patients, including generic health status, quality of life, and sexual function.
  • To estimate the resource use and costs of detection, 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 (6, 7, 8-10), and average result of recruitment and first biopsy prostate-specific antigen (PSA) tests (< 6 vs 6-9.9 vs ≥ 10 ng/mL). Patients are randomized or select a treatment to be followed up in a cohort study.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
  • Procedure: Radical prostatectomy
    radical prostatectomy
  • Radiation: Conformal radiation therapy
    Conformal radiation therapy, external beam
  • Other: Active monitoring
    Active monitoring of Prostate specific antigen levels and disease surveillance
  • Active Comparator: Radical prostatectomy
    Radical prostatectomy
    Intervention: Procedure: Radical prostatectomy
  • Active Comparator: Conformal radiation therapy
    Conformal radiation therapy External beam radiation therapy
    Intervention: Radiation: Conformal radiation therapy
  • Active Comparator: Active monitoring
    Active monitoring of prostate specific antigen levels and disease surveillance
    Intervention: Other: Active monitoring

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100000
June 30, 2021
June 30, 2021   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Fit for the treatments and estimates life expectancy of 10 years Registration with eligible primary care practice

Exclusion Criteria:

Unable to give written informed consent. Concomitant or past malignancy.

Sexes Eligible for Study: Male
50 Years to 69 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT02044172
HTA96/20/99
20141297 ( Registry Identifier: ISRCTN )
Yes
Not Provided
Not Provided
University of Oxford
University of Oxford
University of Bristol
Principal Investigator: Freddie C Hamdy University of Oxford
University of Oxford
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP