Prostate Testing for Cancer and Treatment

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Procedure: Radical prostatectomy; Other: Active monitoring; Radiation: Conformal radiation therapy

• Registration Number: NCT02044172
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2001-06-01
• Study First Submitted: 2014-01-21
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-23
• Primary Completion: 2020-11-14
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-08
• Last Update Posted: 2022-11-14
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 82849

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radical prostatectomy	Radical prostatectomy	Radical prostatectomy
Active monitoring	Active monitoring	Active monitoring of prostate specific antigen levels and disease surveillance
Conformal radiation therapy	Conformal radiation therapy	Conformal radiation therapy External beam radiation therapy

Primary Outcome Measures

Name	Time	Method
Disease specific mortality	Median 15 years follow up

Secondary Outcome Measures

Name	Time	Method
Sexual function	Median 15years
Overall survival	Median 15 years
Disease progression	Median 15 years	Metastases
Treatment complications	Median 15 years
General health status	Median 15 years
Psychological state	Median 15 years
Symptoms	Median 15 years

Trial Locations

Locations (8)

University Hospital of Wales; 🇬🇧 Cardiff, United Kingdom

Leicester General Hospital; 🇬🇧 Leicester, United Kingdom

Queen Elizabeth Hospital; 🇬🇧 Birmingham, United Kingdom

Southmead Hospital; 🇬🇧 Bristol, United Kingdom

Western General Hospital; 🇬🇧 Edinburgh, United Kingdom

Freeman Hospital; 🇬🇧 Newcastle, United Kingdom

Addenbrokes' Hospital; 🇬🇧 Cambridge, United Kingdom

Royal Hallamshire Hospital; 🇬🇧 Sheffield, United Kingdom