Prostate Testing for Cancer and Treatment (ProtecT)

University of Oxford

Status: Active, not recruiting

Conditions: Prostate Cancer

Treatments: Procedure: Radical prostatectomy; Other: Active monitoring; Radiation: Conformal radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02044172

HTA96/20/99

20141297 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82,849 patients

Sex: Male

Ages: 50 to 69 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82,849 participants in 3 patient groups

Radical prostatectomy

Active Comparator group

Description:

Radical prostatectomy

Treatment:

Procedure: Radical prostatectomy

Conformal radiation therapy

Active Comparator group

Description:

Conformal radiation therapy External beam radiation therapy

Treatment:

Radiation: Conformal radiation therapy

Active monitoring

Active Comparator group

Description:

Active monitoring of prostate specific antigen levels and disease surveillance

Treatment:

Other: Active monitoring