Prospective single-arm active surveillance cohort with selective delayed intervention for localized prostate cancer (single academic health sciences centre)
Phase observationalN = 993
- Population
- Men with clinically localized (2010 report) or favorable- or intermediate-risk (2015 report) prostate cancer managed with active surveillance; the 2015 report states a single academic health sciences centre
- Design
- Prospective single-arm cohort managed with an initial expectant approach. Intervention was offered for a PSA doubling time of less than 3 years, Gleason score progression (to 4+3 or greater in the 2010 report) or unequivocal clinical progression. 2010 report: 450 patients, median follow-up 6.8 years (range 1 to 13). 2015 report: 993 men with favorable- or intermediate-risk disease; median follow-up from first biopsy among the 819 survivors 6.4 years (range 0.2 to 19.8).
- Arms
- Active surveillance (single arm) (experimental, n = 993): Initial expectant approach with selective delayed intervention
- People
- Klotz L, senior author Loblaw A
Show the numbers
| Endpoint | Analysis | Active surveillance (single arm) | Control | Effect |
|---|---|---|---|---|
| OS450 patients observed with active surveillance (2010 report) | long term-updatemedian follow-up 6.8 yearsKlotz 2010 | 78.6% | — | Overall survival reported without a time point. Other-cause mortality accounted for almost all deaths; the hazard ratio for nonprostate cancer to prostate cancer mortality was 18.6 at 10 years. |
| Prostate cancer-specific survival450 patients observed with active surveillance (2010 report)10-year prostate cancer actuarial survival | long term-updatemedian follow-up 6.8 yearsKlotz 2010 | 97.2% at 10 y | — | — |
| Prostate cancer-specific survival993 men on active surveillance (2015 report)Actuarial cause-specific survival | long term-updatemedian follow-up 6.4 yearsKlotz 2015 | 98.1% at 10 y; 94.3% at 15 y | — | Median follow-up from first biopsy among the 819 survivors. 15 deaths (1.5%) from prostate cancer among 993 men. |
| Remaining untreated on surveillance993 men on active surveillance (2015 report) | long term-updatemedian follow-up 6.4 yearsKlotz 2015 | 75.7% at 5 y; 63.5% at 10 y; 55% at 15 y | — | — |
| Endpoint | Analysis | Active surveillance (single arm) | Control | Effect |
|---|---|---|---|---|
| OS450 patients observed with active surveillance (2010 report) | long term-updatemedian follow-up 6.8 yearsKlotz 2010 | 78.6% | — | Overall survival reported without a time point. Other-cause mortality accounted for almost all deaths; the hazard ratio for nonprostate cancer to prostate cancer mortality was 18.6 at 10 years. |
| Prostate cancer-specific survival450 patients observed with active surveillance (2010 report)10-year prostate cancer actuarial survival | long term-updatemedian follow-up 6.8 yearsKlotz 2010 | 97.2% at 10 y | — | — |
| Prostate cancer-specific survival993 men on active surveillance (2015 report)Actuarial cause-specific survival | long term-updatemedian follow-up 6.4 yearsKlotz 2015 | 98.1% at 10 y; 94.3% at 15 y | — | Median follow-up from first biopsy among the 819 survivors. 15 deaths (1.5%) from prostate cancer among 993 men. |
| Remaining untreated on surveillance993 men on active surveillance (2015 report) | long term-updatemedian follow-up 6.4 yearsKlotz 2015 | 75.7% at 5 y; 63.5% at 10 y; 55% at 15 y | — | — |
- Active surveillance (single arm) (experimental)
Data table (modelled values)
| Months | Active surveillance (single arm) |
|---|---|
| 0 | 100.0% |
| 49 | 99.5% |
| 97 | 98.8% |
| 146 | 96.7% |
| 194 | 94.3% |
- Active surveillance (single arm) (experimental)
Data table (modelled values)
| Months | Active surveillance (single arm) |
|---|---|
| 0 | 100.0% |
| 49 | 79.4% |
| 97 | 67.4% |
| 146 | 59.6% |
| 194 | 55.0% |
Appears in
Sources
Klotz L, Zhang L, Lam A, Nam R, Mamedov A, Loblaw A. Clinical results of long-term follow-up of a large, active surveillance cohort with localized prostate cancer. J Clin Oncol. 2010;28(1):126-31.
Klotz L, Vesprini D, Sethukavalan P, Jethava V, Zhang L, Jain S, et al. Long-term follow-up of a large active surveillance cohort of patients with prostate cancer. J Clin Oncol. 2015;33(3):272-7.