Table 1. Characteristics, eligibility criteria, monitoring protocols, definitions of progression and outcomes in studies with predefined measures of disease progression and restricted to men with localised (T1-T2) disease, ordered by length of follow-up, 1988-2004 (continued overleaf).
| 1st author, setting (year published) |
N (yrs recruited) |
Design | Eligibility | Median age ± SD (range), yrs |
Median initial PSA, ng/ml (range) |
Stage (%) | Monitoring protocol |
|---|---|---|---|---|---|---|---|
| Chen, Taichung Veterans Hospital, Taiwan, (2003)15 |
52 (1983- 1996) |
R | Men undergoing TURP for clinically diagnosed BPH with stage T1a cancer. |
71.5* ± 7 | - | T1a (100%) | 3-6 monthly DRE & PSA. |
| Patel, Baylor College of Medicine & Memorial Sloan Kettering Cancer Centre, USA (2004)13 |
88 (1984- 2001) |
R | Clinically localised cancer; Gleason score ≤ 7; eligible for radical treatment; no significant co- morbidities. |
65.3* (44-79) |
5.9 (0.09-30.2) | T1a/b (20%) T1c (58%) T2a-c (22%) |
DRE & PSA every 3 mo for yr 1 & every 6 mo afterwards. TRUS guided sextant biopsy at 6 mo & if DRE/TRUS or PSA abnormalities. PSA velocity calculated from 3 values over 12 mo. |
| Choo, Toronto (2002)16,28,29 | 206 (1995- 2000) |
P | T1b-T2b N0M0, Gleason ≤ 7, PSA ≤ 15 ng/ml |
70 (49-84) |
6.5 (0.3-14.6) | T1b (6%); T1c (57%) T2a (24%); T2b (13%) |
Follow-up every 3 mo for 2 yrs & every 6 mo afterwards with PSA and DRE. TRUS every 6 mo; rpt biopsy at 12-18 mo; bone scan at 12 mo for 1st 2 yrs (then every 24 mo or 12 mo if PSA > 15 ng/ml). |
| Mohler, University of North Carolina (1997)23 |
27 (1991- 1996) |
P | All pts with clinical stage T1c disease. | 69* ± 5 yrs | 5.3 ± 9.8* | T1c (100%) | Follow-up at 3 mo and then 6 monthly with clinical examination, PSA, creatinine and haematocrit. |
| Khan, John Hopkins University USA, (2003)14,26,27 |
78 (1992- 2002) |
P | T1c, PSA density < 15 ng/ml/cm3; Gleason < 7; no grade 4/5; < 3 cores involved with cancer; ≤ 50% involvement of any core |
65 ± 4.5 (50-74) |
4.6 ± 2.3 (0.8-11.9) | T1c (100%) | Twice yearly total and %fPSA, DRE, annual TRUS biopsy (12 cores). |
| 1st author | Definition of progression | Median follow-up (range) |
% progressed (median time; range) |
Probability of freedom from progression |
Probability of freedom from treatment |
Reasons for abandoning monitoring |
|---|---|---|---|---|---|---|
| Chen15 | Abnormal DRE and/or progressive elevation of PSA “proved” by transrectal needle biopsy, or appearance of metastatic disease. |
7.3 yrs (0.5- 15) |
8% | 72% at 5 yrs 60% at 10 yrs |
- | 3 (6%) progressed to stage T2a disease; 1 (2%) progressed to bony mets. |
| Patel13 | Progression defined as a total of ≥ three points awarded for: i) Gleason score increases (increases of 1, > 1 or any new Gleason pattern 4 or 5 awarded 1, 2, and 3 points, respectively); ii) PSA velocity (> 0.75 ng/ml/year in 12 or 24 months awarded 2 and 3 points, respectively); iii) DRE/TRUS findings (increasing old lesion, new lesion not biopsy proven and new biopsy proven lesion awarded 1, 2, and 3 points, respectively); iv) biopsy (bilateral or multifocal cancer, and greater than four cores with cancer awarded 2 and 3 points, respectively). |
44.1 mo (7- 172) |
25% (45 mo; 7-84) |
95% at 1 yr 88% at 2 yrs 67% at 5 yrs 56% at 10 yrs |
93% at 1 yr 84% at 2 yrs 58% at 5 yrs 41% at 10 yrs |
31 (35%) withdrew (17 objective progression; 7 pt anxiety; 7 pt anxiety + ‘ominous features’) (no mets reported). |
| Choo16,28,29 | Any of i) PSA progression (co-existance of PSA doubling time < 2 years + final PSA > 8ng/ml + p < 0.05 on regression of lnPSA on time); ii) clinical progression (based on DRE, symptoms requiring TURP, ureteric obstruction, bone scan, radiologic/clinical evidence of metastases); iii) histological progression (Gleason score upgraded to 8 or greater). |
29 mo (2-66) | 17% | 81% (± 6.2) at 2 yrs; 67% (+/− 12%) at 4 yrs. |
67% (± 7.3) at 2 yrs 48% (± 10.7) at 4 yrs |
69 (33%) withdrew: 15 = clinical progression; 16 = PSA; 5 = histological; 23 = pt request; 6=protocol violation; 4 = other death (no mets). |
| Mohler23 | Clinical criteria: development of palpable disease on DRE, gross haematuria, UTI, symptoms of bladder outlet obstruction, evidence of metastatic disease on physical examination or radiography; Biochemical criteria: increase in serum PSA on 3 consecutive measures and total increase ≥ 5 ng/ml. |
23 mo (6- 62)* |
33% (23 mo) | - | 85% | 15% (4/27) of men withdrew due to PSA progression (no mets). |
| Khan14,26,27 | Progression defined as unfavourable repeat 12-core biopsy findings: Gleason score ≥ 7; or any Gleason pattern 4 or 5; or ≥ 3 cores involved with cancer; or > 50% involvement of any core with cancer. |
≈ 23 mo27 | 29% (20 mo) | - | 76% | (no mets reported). |
BPH: benign prostatic hyperplasia; DRE: digital rectal examination; %fPSA: percent free PSA; P: prospective case-series; R: retrospective case-series; TRUS: trans-rectal ultrasound guided biopsy; TURP: transurethral resection of prostate.
*
mean value (± SD if given)