Prostate Testing for Cancer and Treatment — ProtecT  

Prostate Cancer Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT02044172
• Study type: Interventional
• Source: University of Oxford
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2001
• Completion date: March 31, 2027