Prostate Testing for Cancer and Treatment

Prostate Cancer Clinical Trial

— ProtecT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02044172
• Other study ID #: HTA96/20/99
• Secondary ID: 20141297
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2001
• Est. completion date: March 31, 2027

Study information

• Verified date: November 2022
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Other known NCT identifiers

• NCT00632983

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 82849
• Est. completion date: March 31, 2027
• Est. primary completion date: November 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Radical prostatectomy
radical prostatectomy

Radiation:
• Conformal radiation therapy
Conformal radiation therapy, external beam

Other:
• Active monitoring
Active monitoring of Prostate specific antigen levels and disease surveillance

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	University of Bristol

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Lane JA, Hamdy FC, Martin RM, Turner EL, Neal DE, Donovan JL. Latest results from the UK trials evaluating prostate cancer screening and treatment: the CAP and ProtecT studies. Eur J Cancer. 2010 Nov;46(17):3095-101. doi: 10.1016/j.ejca.2010.09.016. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease specific mortality		Median 15 years follow up
Secondary	Overall survival		Median 15 years
Secondary	Disease progression	Metastases	Median 15 years
Secondary	Treatment complications		Median 15 years
Secondary	General health status		Median 15 years
Secondary	Psychological state		Median 15 years
Secondary	Symptoms		Median 15 years
Secondary	Sexual function		Median 15years

External Links

•   Project website