An interventional study of Radical prostatectomy and Conformal radiation therapy in Prostate Cancer, sponsored by University of Oxford. Active, not recruiting at 8 sites in United Kingdom. Open to male participants aged 50 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-14.
Sponsored by University of Oxford · Not applicable, Interventional, and Treatment
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.
OBJECTIVES:
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 82,849 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Radical prostatectomy
Procedure: Radical prostatectomy
Conformal radiation therapy External beam radiation therapy
Radiation: Conformal radiation therapy
Active monitoring of prostate specific antigen levels and disease surveillance
Other: Active monitoring
radical prostatectomy
Conformal radiation therapy, external beam
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
Metastases
Time frame: Median 15 years
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
This study is active, not recruiting, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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University of Oxford