Prostate Testing for Cancer and Treatment (ProtecT)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02044172 |
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Recruitment Status :
Active, not recruiting
First Posted : January 23, 2014
Last Update Posted : November 14, 2022
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer | Procedure: Radical prostatectomy Radiation: Conformal radiation therapy Other: Active monitoring | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 82849 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | The ProtecT Trial - Evaluating the Effectiveness of Treatments for Clinically Localised Prostate Cancer |
| Actual Study Start Date : | June 1, 2001 |
| Actual Primary Completion Date : | November 14, 2020 |
| Estimated Study Completion Date : | March 31, 2027 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Radical prostatectomy
Radical prostatectomy
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Procedure: Radical prostatectomy
radical prostatectomy |
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Active Comparator: Conformal radiation therapy
Conformal radiation therapy External beam radiation therapy
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Radiation: Conformal radiation therapy
Conformal radiation therapy, external beam |
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Active Comparator: Active monitoring
Active monitoring of prostate specific antigen levels and disease surveillance
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Other: Active monitoring
Active monitoring of Prostate specific antigen levels and disease surveillance |
- Disease specific mortality [ Time Frame: Median 15 years follow up ]
- Overall survival [ Time Frame: Median 15 years ]
- Disease progression [ Time Frame: Median 15 years ]Metastases
- Treatment complications [ Time Frame: Median 15 years ]
- General health status [ Time Frame: Median 15 years ]
- Psychological state [ Time Frame: Median 15 years ]
- Symptoms [ Time Frame: Median 15 years ]
- Sexual function [ Time Frame: Median 15years ]
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| Ages Eligible for Study: | 50 Years to 69 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044172
| 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, United Kingdom | |
| Principal Investigator: | Freddie C Hamdy | University of Oxford |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Oxford |
| ClinicalTrials.gov Identifier: | NCT02044172 |
| Obsolete Identifiers: | NCT00632983 |
| Other Study ID Numbers: |
HTA96/20/99 20141297 ( Registry Identifier: ISRCTN ) |
| First Posted: | January 23, 2014 Key Record Dates |
| Last Update Posted: | November 14, 2022 |
| Last Verified: | November 2022 |
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Prostate cancer Treatment Screening |
Surgery Radiotherapy Active monitoring |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |