Prostate Testing for Cancer and Treatment

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Radical prostatectomy
* Radiation: Conformal radiation therapy
* Other: Active monitoring


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radical prostatectomy<br>Radical prostatectomy | Procedure: Radical prostatectomy<br>* radical prostatectomy<br>|
| Active Comparator: Conformal radiation therapy<br>Conformal radiation therapy External beam radiation therapy | Radiation: Conformal radiation therapy<br>* Conformal radiation therapy, external beam<br>|
| Active Comparator: Active monitoring<br>Active monitoring of prostate specific antigen levels and disease surveillance | Other: Active monitoring<br>* Active monitoring of Prostate specific antigen levels and disease surveillance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease specific mortality |  | Median 15 years follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Median 15 years | 
| Disease progression | Metastases | Median 15 years | 
| Treatment complications |  | Median 15 years | 
| General health status |  | Median 15 years | 
| Psychological state |  | Median 15 years | 
| Symptoms |  | Median 15 years | 
| Sexual function |  | Median 15years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Treatment, Screening, Surgery, Radiotherapy, Active monitoring