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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 : January 25, 2018
Sponsor:
Collaborator:
University of Bristol
Information provided by (Responsible Party):
University of Oxford

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.


Condition or disease Intervention/treatment
Prostate Cancer Procedure: Radical prostatectomy Radiation: Conformal radiation therapy Other: Active monitoring

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 : Interventional  (Clinical Trial)
Actual Enrollment : 100000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The ProtecT Trial - Evaluating the Effectiveness of Treatments for Clinically Localised Prostate Cancer
Actual Study Start Date : June 1, 2001
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Radical prostatectomy
Radical prostatectomy
Procedure: Radical prostatectomy
radical prostatectomy
Active Comparator: Conformal radiation therapy
Conformal radiation therapy External beam radiation therapy
Radiation: Conformal radiation therapy
Conformal radiation therapy, external beam
Active Comparator: Active monitoring
Active monitoring of prostate specific antigen levels and disease surveillance
Other: Active monitoring
Active monitoring of Prostate specific antigen levels and disease surveillance



Primary Outcome Measures :
  1. Disease specific mortality [ Time Frame: Median 10 years follow up ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Median 10 years ]
  2. Disease progression [ Time Frame: Median 10 years ]
    Metastases

  3. Treatment complications [ Time Frame: Median 10 years ]
  4. General health status [ Time Frame: Median 10 years ]
  5. Psychological state [ Time Frame: Median 10 years ]
  6. Symptoms [ Time Frame: Median 10 years ]
  7. Sexual function [ Time Frame: Median 10 years ]
  8. Resource use [ Time Frame: Median 10 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

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): NCT02044172


Locations
United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
Southmead Hospital
Bristol, United Kingdom
Addenbrokes' Hospital
Cambridge, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
Western General Hospital
Edinburgh, United Kingdom
Leicester General Hospital
Leicester, United Kingdom
Freeman Hospital
Newcastle, United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom
Sponsors and Collaborators
University of Oxford
University of Bristol
Investigators
Principal Investigator: Freddie C Hamdy University of Oxford

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02044172     History of Changes
Obsolete Identifiers: NCT00632983
Other Study ID Numbers: HTA96/20/99
20141297 ( Registry Identifier: ISRCTN )
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

Keywords provided by University of Oxford:
Prostate cancer
Treatment
Screening
Surgery
Radiotherapy
Active monitoring

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases