Appendix 1: Summary of active monitoring studies without a predefined measure of disease progression (1988-2004) (ordered by stage & publication yr).
| 1st author, setting (year published) |
N (yrs recruited) |
Eligibility | Median age ± SD (range) |
Median initial PSA, ng/ml (range) |
Stage (%); median Gleason score |
Median follow-up (range) |
% choosing active treatment† during follow-up |
Reasons for abandoning active monitoring |
|---|---|---|---|---|---|---|---|---|
| LOCALISED DISEASE ONLY (STAGE T1-T2) | ||||||||
| El-Geneidy, Portland VA Medical Centre (2004)6 |
175 (1993- 2000) |
T1-T2 NXM0 | 71 (50- 86) |
6.9 (0.5-76.5) | T1 or T2 (31% stage T1c); 6 |
3.3 yrs (0.1-8.6) |
22% | PSA increase only: 32%; signs of local tumour progression: 8%; pt wish, no evidence of progression: 45%; unknown: 16%. PSA DT < 3 yrs (in 23% of pts) was associated with 3 fold increased rate of active treatment (p < 0.02; multivariable analysis). |
| Carter, Centre for Prostate Disease Research, (2003)7 |
313 (1991- 2002) |
Age ≤ 70; Gleason ≤ 6; no grade 4; PSA ≤ 20 ng/ml; ≤ 3 + ve cores; stage ≤ 2 |
65 (41- 70) |
5.1 (0.5-20) | Low grade, localised (60% stage T1c); 5 |
3.8 yrs (0.5-10.5) |
57.3% and 73.2% within 2 and 4 yrs respectively |
PSA DT < 2 yrs (in 22% of pts) was associated with > 3 fold increased rate of active treatment (p < 0.0001; multivariable analysis). |
| Meng, CaPSURE database (2003)8 |
457 (1989- 2001) |
Stage ≤ 3a N0M0; expectant initial treatment |
- | - | Localised (46% stage T1); - |
- | 41% at median 1.7 yrs. Only 15% went from low- intermediate / high risk on PSA criteria |
In multivariable models, men aged ≥ 75, < college educated, income < $30K, were 65%, 37% & 58% less likely, respectively, to abandon watchful waiting. Those with absolute PSA change from base ≥ 2 ng/ml had 3 fold rate of active treatment. |
| Zeitman, Massachusetts General Hospital (2001)9 |
198 (1990- 1999) |
T1-T2NXM0, PSA < 20 ng/ml |
71 | 6.6 | Localised (21% stage T1c); - |
3.4 | 57% of those alive by 5 yrs; 74% of those alive by 7 yrs. |
Of treated pts 81% believed the physician initiated therapy because of PSA increase or a nodule; physicians recorded advocating treatment due to clinical or biochemical progression in 24%. |
| Nam,Toronto, (1998)10 |
141 (1990- 1995) |
Clinically localised | 69 (53- 80) |
- | Localised disease (stage not stated); - |
1.7 yrs (0.2-4.1) |
48% underwent radical surgery |
Patient preference (none based on PSA velocity). |
| Gerber, Univ of Chicago, (1998)5 |
49 (1989- 1996) |
Stage T1-T2 | 71.9 ± 7.0 (55- 84) |
12.3 ±11.1* (1.1-49.0) |
Localised (T1c: 47%); - |
32 mo* (12-69). |
12% of those alive & not lost to follow-up. |
Patient preference – not based on uniform criteria. |
| INCLUDES LOCALLY ADVANCED/DISTANT METASTATIC DISEASE (STAGE T3-T4) | ||||||||
| Ross, McGill University, Canada, (2004)12. |
142 (1994- ?) |
Clinically localised prostate cancer |
69* (51- 87) |
8.1 (0.23-41) | T1-T3 (54% stage T1c); 57% Gleason score = 5-6 |
3.95 yrs (0.3-13) |
28% | “The decision…was on an individual basis. No specific criteria..” |
| Wu, Dept of Defence Centre for Prostate Disease Research (2004)11 |
1,158 (1990- 2001) |
Expectant initial treatment; no metastases |
70.9 | 6.4 | T1-T4 (53.6% T1; 41.7% T2); 37.8% Gleason = 5-6 |
2.8 yrs (0.8-11.3) |
39.1% | In multivariable models, LogPSA and clinical stage were positively associated, and age at diagnosis was inversely associated, with active treatment |
DRE: digital rectal examination; CaPSURE: Cancer of the Prostate Strategic Urologic Research Endeavour. PSA DT: Prostate specific antigen doubling time.
†
Radical prostatectomy, radiotherapy, hormonal treatment.
*
mean value used