Prostate Testing for Cancer and Treatment (ProtecT)

November 8, 2022 updated by: University of Oxford

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Actual)

82849

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom
        • Queen Elizabeth Hospital
      • Bristol, United Kingdom
        • Southmead Hospital
      • Cambridge, United Kingdom
        • Addenbrokes' Hospital
      • Cardiff, United Kingdom
        • University Hospital of Wales
      • Edinburgh, United Kingdom
        • Western General Hospital
      • Leicester, United Kingdom
        • Leicester General Hospital
      • Newcastle, United Kingdom
        • Freeman Hospital
      • Sheffield, United Kingdom
        • Royal Hallamshire Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 69 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease specific mortality
Time Frame: Median 15 years follow up
Median 15 years follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Median 15 years
Median 15 years
Disease progression
Time Frame: Median 15 years
Metastases
Median 15 years
Treatment complications
Time Frame: Median 15 years
Median 15 years
General health status
Time Frame: Median 15 years
Median 15 years
Psychological state
Time Frame: Median 15 years
Median 15 years
Symptoms
Time Frame: Median 15 years
Median 15 years
Sexual function
Time Frame: Median 15years
Median 15years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

University of Bristol

Investigators

  • Principal Investigator: Freddie C Hamdy, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2001

Primary Completion (ACTUAL)

November 14, 2020

Study Completion (ANTICIPATED)

March 31, 2027

Study Registration Dates

First Submitted

January 21, 2014

First Submitted That Met QC Criteria

January 21, 2014

First Posted (ESTIMATE)

January 23, 2014

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HTA96/20/99
  • 20141297 (REGISTRY: ISRCTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on Radical prostatectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe