Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT02044172

Prostate Testing for Cancer and Treatment

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

50 year–69 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Queen Elizabeth Hospital, Birmingham, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

radical prostatectomy

Procedure

radical prostatectomy

Conformal radiation therapy

Radiation

Conformal radiation therapy, external beam

Active Monitoring

Other

Active monitoring of Prostate specific antigen levels and disease surveillance

Primary outcomes

  1. Disease specific mortality

    Time frame: Median 15 years follow up

Secondary outcomes

  1. Overall survival

    Time frame: Median 15 years

  2. Disease progression

    Time frame: Median 15 years

    Metastases

  3. Treatment complications

    Time frame: Median 15 years

  4. General health status

    Time frame: Median 15 years

  5. Psychological state

    Time frame: Median 15 years

  6. Symptoms

    Time frame: Median 15 years

  7. Sexual function

    Time frame: Median 15years

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • University of Bristol

Registry information

Official study title

The ProtecT Trial - Evaluating the Effectiveness of Treatments for Clinically Localised Prostate Cancer

Acronym: ProtecT

Important dates

Study start
2001
Primary completion
2020
Study completion
2027
First posted
Jan 23, 2014
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.