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Prostate Testing for Cancer and Treatment (ProtecT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02044172
Recruitment Status : Active, not recruiting
First Posted : January 23, 2014
Last Update Posted : June 22, 2020
Sponsor:
Collaborator:
University of Bristol
Information provided by (Responsible Party):
University of Oxford

Tracking Information
First Submitted Date  ICMJE January 21, 2014
First Posted Date  ICMJE January 23, 2014
Last Update Posted Date June 22, 2020
Actual Study Start Date  ICMJE June 1, 2001
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2020)
Disease specific mortality [ Time Frame: Median 15 years follow up ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 21, 2014)
Disease specific mortality [ Time Frame: Median 10 years follow up ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2020)
  • Overall survival [ Time Frame: Median 15 years ]
  • Disease progression [ Time Frame: Median 15 years ]
    Metastases
  • Treatment complications [ Time Frame: Median 15 years ]
  • General health status [ Time Frame: Median 15 years ]
  • Psychological state [ Time Frame: Median 15 years ]
  • Symptoms [ Time Frame: Median 15 years ]
  • Sexual function [ Time Frame: Median 15years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2014)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prostate Testing for Cancer and Treatment
Official Title  ICMJE The ProtecT Trial - Evaluating the Effectiveness of Treatments for Clinically Localised Prostate Cancer
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 21, 2014)
100000
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02044172
Other Study ID Numbers  ICMJE HTA96/20/99
20141297 ( Registry Identifier: ISRCTN )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Oxford
Study Sponsor  ICMJE University of Oxford
Collaborators  ICMJE University of Bristol
Investigators  ICMJE
Principal Investigator: Freddie C Hamdy University of Oxford
PRS Account University of Oxford
Verification Date January 2018

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