Background
Methods
The ProCaSP Study
Data collection
European organisation of research and treatment in cancer quality of life questionnaire, core module (EORTC QLQ-C30)
Patient-oriented prostate utility scale (PORPUS)
International index of erectile function (IIEF)
Ethics and consent
Statistical analysis
Post hoc statistical power analysis
Results
Patients and tumour characteristics
Radical prostatectomy | Radiotherapy | p-value1 | |||||
---|---|---|---|---|---|---|---|
Non-nerve-sparing (reference) | Nerve-sparing | Total | Brachytherapy | Combined (External/brachytherapy) | External | ||
(n = 256) | (n = 127) | (n = 133) | (n = 44) | (n = 37) | (n = 52) | ||
Age [mean ± SD] | 64.2 ± 6.3 | 59.7 ± 6.1 | 66.5 ± 5.5 | 65.0 ± 6.0 | 66.8 ± 5.5 | 67.7 ± 4.8 | <0.001 |
Partnership [N (%)] | |||||||
Not living with a partner | 14 (5.5) | 6 (4.7) | 10 (7.5) | 4 (9.1) | 3 (8.1) | 3 (5.8) | 0.586 |
Married or having a spouse | 239 (93.4) | 120(94.5) | 121 (91.0) | 39 (88.6) | 33 (89.2) | 49 (94.2) | |
Missing | 3 (1.2) | 1 (0.8) | 2 (1.5) | 1 (2.3) | 1 (2.7) | 0 (0.0) | |
Education [N (%)] | |||||||
without | - | - | 2 (1.5) | 0 (0.0) | 0 (0.0) | 2 (3.8) | 0.113 |
8-9 years | 127 (49.6) | 50 (39.4) | 65 (48.9) | 20 (45.5) | 21 (56.8) | 24 (46.2) | |
10-11 years | 59 (23.0) | 31 (24.4) | 27 (20.3) | 11 (25.0) | 10 (27.0) | 6 (11.5) | |
>=12 years | 70 (27.3) | 45 (35.4) | 38 (28.6) | 13 (29.5) | 6 (16.2) | 19 (36.5) | |
Missing | - | 1 (0.8) | 1 (0.8) | 0 (0.0) | 0 (0.0) | 1 (1.9) | |
Employment status [N (%)] | |||||||
Employed | 70 (27.3) | 67 (52.8) | 17 (12.8) | 9 (20.5) | 2 (5.4) | 6 (11.5) | <0.001 |
Non employed | 180 (70.3) | 59 (46.5) | 114 (85.7) | 33 (75.0) | 35 (94.6) | 46 (88.5) | |
Missing | 6 (2.3) | 1 (0.8) | 2 (1.5) | 2 (4.5) | 0 (0.0) | 0 (0.0) | |
Living area [N (%)] | |||||||
Rural | 149 (58.3) | 85 (66.9) | 56 (42.1) | 29 (65.9) | 18 (48.6) | 9 (17.3) | <0.001 |
Urban | 102 (39.8) | 40 (31.5) | 71 (53.4) | 12 (27.3) | 17 (45.9) | 42 (80.8) | |
Missing | 5 (2.0) | 2 (1.6) | 6 (4.5) | 3 (6.8) | 2 (5.4) | 1 (1.9) | |
Pre-therapeutic Gleason score, [mean ± SD] | 6.6 ± 1.2 | 6.5 ± 1.0 | 6.0 ± 13.1 | 5.4 ± 1.4 | 6.1 ± 1.6 | 6.4 ± 1.1 | 0.110 |
Missing [N] | 2 | 1 | 33 | 25 | 7 | 3 | |
Pre-therapeutic PSA score, [mean ± SD] | 11.4 ± 21.3 | 8.0 ± 4.7 | 13.7 ± 17.0 | 10.8 ± 15.0 | 17.6 ± 14.4 | 13.2 ± 19.9 | 0.032 |
Missing [N] | 5 | 1 | 2 | 1 | 1 | - | |
Pre-baseline androgen deprivation therapy [N (%)] | |||||||
Yes | 10 (3.9) | 1 (0.8) | 51 (38.3) | 20 (45.4) | 13 (35.1) | 18 (34.6) | <0.001 |
No | 185 (72.2) | 81 (63.8) | 46 (34.6) | 16 (36.4) | 12 (32.4) | 19 (36.5) | |
Missing | 61 (23.8) | 45 (35.4) | 36 (27.0) | 8 (18.2) | 12 (32.4) | 16 (30.8) | |
Tumour stage at diagnosis [N %)] | |||||||
T1 | 2 (0.8) | - | 32 (24.0) | 1 (2.3) | 1 (2.7) | 29 (55.8) | <0.001 |
T2 | 142 (55.5) | 103 (81.1) | 39 (29.3) | 8 (18.2) | 17 (45.9) | 14 (26.9) | |
T3 | 105 (41.0) | 21 (16.5) | 20 (15.0) | 1 (2.3) | 12 (32.4) | 7 (13.5) | |
Missing | 7 (2.7) | 3 (2.4) | 43 (32.3) | 34 (77.3) | 7 (18.9) | 2 (3.8) | |
Risk stratification [N (%)] | |||||||
Low | 13 (5.1) | 7 (5.5) | 25 (18.8) | 6 (13.6) | 0 (0.0) | 19 (36.5) | <0.001 |
Intermediate | 33 (12.9) | 15 (11.8) | 22 (16.5) | 2 (4.5) | 8 (21.6) | 12 (23.1) | |
High | 205 (80.1) | 103 (81.1) | 47 (35.3) | 4 (9.1) | 25 (67.6) | 18 (34.6) | |
Missing | 5 (1.9) | 2 (1.6) | 39 (29.3) | 32 (72.7) | 4 (10.8) | 3 (5.8) | |
Operation condition [N (%)] | |||||||
Retropubic | 251 (98.0) | 124 (97.6) | n.a. | n.a. | n.a. | n.a. | n.a. |
Perineal | 5 (2.0) | 2 (1.6) | |||||
Missing | - | 1 (0.8) | |||||
Sexual functioning, [mean ± SD] | 41.5 ± 21.2 | 54.7 ± 16.5 | 33.1 ± 22.3 | 26.7 ± 22.1 | 32.4 ± 21.6 | 39.7 ± 21.7 | <0.001 |
Missing [N] | 92 | 36 | 44 | 11 | 15 | 18 |
Sexual functioning - IIEF
Generic HRQOL – QLQ-C30
Main analysis | Analysis with separation of different RT treatment groups1 | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Radical prostatectomy | Radiotherapy | Wald test | Radiotherapy | Wald test | |||||||||
Ref. | Nerve-sparing | Total | Brachytherapy | Combined (External/brachytherapy) | External | ||||||||
b | b | 95%-CI | b | 95%-CI | p-value | b | 95%-CI | b | 95%-CI | b | 95%-CI | p-value | |
QLQ-C30
| |||||||||||||
Functioning scales | |||||||||||||
Global health status | 0 | 2.9 | (−0.6, 6.4) | −2.0 | (−5.9, 2.0) | 0.098 | −1.0 | (−6.2, 4.2) | −2.2 | (−8.4, 3.9) | −4.4 | (−9.9, 1.2) | 0.120 |
Physical functioning | 0 | 1.7 | (−0.6, 4.1) | −0.9 | (−4.3, 2.4) | 0.198 | −0.6 | (−5.4, 4.3) | −0.6 | (−5.2, 3.9) | −3.5 | (−8.9, 2.0) | 0.224 |
Role functioning | 0 | 1.9 | (−1.5, 5.3) | −0.5 | (−4.8, 3.8) | 0.425 | −1.6 | (−7.9, 4.7) | 2.0 | (−4.7, 8.7) | −2.5 | (−8.8, 3.8) | 0.314 |
Emotional functioning | 0 | 3.8 | (−0.2, 7.8) | −2.7 | (−7.3, 2.0) | 0.074 | −2.4 | (−8.7, 3.9) | 1.1 | (−6.2, 8.3) |
−8.6
|
(−15.2, −2.0)
| 0.028 |
Cognitive functioning | 0 | 2.5 | (−1.1, 6.2) | −1.8 | (−5.5, 1.9) | 0.170 | −0.7 | (−6.0, 4.5) | −2.2 | (−8.2, 3.8) | −2.7 | (−9.5, 4.0) | 0.277 |
Social functioning | 0 | 1.2 | (−3.7, 6.1) | 0.1 | (−5.4, 5.5) | 0.650 | −0.7 | (−7.9, 6.5) | 3.0 | (−5.1, 11.1) | −5.7 | (−14.3, 3.0) | 0.287 |
Symptom scales
| |||||||||||||
Fatigue | 0 | −3.6 | (−7.8, 0.5) | 0.4 | (−4.6, 5.3) | 0.173 | 0.1 | (−6.6, 6.8) | −1.6 | (−9.1, 5.9) | 5.4 | (−2.0, 12.9) | 0.174 |
Nausea and vomiting | 0 | −0.5 | (−1.6, 0.6) | 1.1 | (−0.5, 2.7) | 0.100 |
2.1
|
(0.1, 4.1)
| −0.5 | (−2.2, 1.2) | 0.6 | (−1.8, 2.9) | 0.091 |
Pain | 0 | 0.5 | (−3.5, 4.5) | 2.7 | (−2.2, 7.5) | 0.477 | 3.6 | (−3.3, 10.5) | 0.1 | (−7.2, 7.3) | 3.4 | (−4.8, 11.6) | 0.601 |
Dyspnoea | 0 | 1.4 | (−2.1, 4.8) | 3.5 | (−0.8, 7.8) | 0.177 | 0.1 | (−5.6, 5.8) | 6.8 | (−0.5, 14.1) | 4.8 | (−1.5, 11.0 | 0.122 |
Insomnia | 0 | 0.1 | (−4.7, 5.0) | 3.2 | (−2.5, 8.9) | 0.451 | 4.3 | (−2.9, 11.5) | 4.0 | (−4.7, 12.7) | 6.4 | (−2.8, 15.6) | 0.291 |
Appetite loss | 0 | −0.1 | (−2.3, 2.1) | 1.5 | (−1.7, 4.7) | 0.317 | 1.5 | (−1.8, 4.8) | 1.0 | (−3.7, 5.6) | 3.1 | (−1.5, 7.6) | 0.276 |
Constipation | 0 | −1.2 | (−5.3, 3.0) | 0.4 | (−4.1, 4.9) | 0.542 | 1.7 | (−4.2, 7.5) | −0.9 | (−8.4, 6.5) | 3.2 | (−5.5, 12.0) | 0.362 |
Diarrhoea | 0 | −0.9 | (−4.4, 2.6) |
7.0
|
(2.5, 11.6)
|
0.006
|
7.8
|
(1.0, 14.5)
| 4.1 | (−3.3, 11.4) | 4.2 | (−3.6, 12.0) |
0.048
|
Financial difficulties | 0 | −3.1 | (−7.0, 0.8) | −0.2 | (−4.7, 4.3) | 0.257 | −2.7 | (−9.1, 3.7) | −0.5 | (−8.8, 7.7) | 4.9 | (−4.0, 13.8) | 0.216 |
PORPUS
| |||||||||||||
PORPUS-P | 0 |
2.3
|
(0.1, 4.6)
| 2.2 | (−0.6, 5.0) |
0.045
| 2.2 | (−1.6, 6.1) | 3.3 | (−0.6, 7.2) | 1.4 | (−3.0, 5.7) | 0.119 |
Disease-specific quality of life – PORPUS-P
Comparison of generic HRQOL to German norm values
Baseline | 24 months after baseline | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Radical prostatectomy | Radiotherapy | Radical prostatectomy | Radiotherapy | |||||||||
nns | ns | total | brachy | comb | extern | nns | ns | total | brachy | comb | extern | |
Global quality of life
| 2.5 | 5.3 | 1.5 | 4.6 | −1.7 | 1.3 | 5.3 | 10.3 | 2.0 | 3.8 | 2.8 | 0.1 |
Functioning scales
| ||||||||||||
Physical | 7.3 | 9.6 | 3.0 | 3.5 | 2.3 | 3.2 | 5.0 | 8.5 | 0.0 | 1.6 | −1.3 | −0.5 |
Role | 9.7 |
14.0
| 3.6 |
11.0
| 2.3 |
12.2
| 9.7 |
14.1
| 4.6 | −0.5 | 5.9 | 9.6 |
Emotional | −8.7 | −9.3 | −3.8 | −2.8 |
−13.2
| 1.5 | −1.6 | 4.4 | −0.4 | 2.1 | −2.7 | −1.6 |
Cognitive | 1.4 | 2.1 | 1.7 | 3.9 | −1.5 | 2.1 | −2.4 | 2.0 | −1.6 | 0.8 | −6.5 | −0.2 |
Social | −3.1 | −2.9 | −4.9 | −6.4 |
−13.1
| 2.4 | −5.2 | −1.8 | −2.2 | −7.5 | 1.9 | 1.5 |
Symptom scales
| ||||||||||||
Fatigue |
−10.0
|
−13.5
| −6.9 | −9.9 | −0.4 | −9.3 | −4.5 | −9.8 | −3.4 | −3.5 | −1.5 | −4.6 |
Nausea/Vomiting | −1.1 | −1.7 | 0.4 | 1.8 | 1.9 | −1.6 | −0.8 | −1.7 | −0.6 | 0.8 | −1.3 | −1.6 |
Pain |
−12.9
|
−19.0
| −8.7 | −8.3 | −7.0 |
−10.5
| −9.6 |
−14.0
| −6.8 | −5.4 |
−10.8
| −9.4 |
Single items
| ||||||||||||
Dyspnoea | −9.3 | −9.0 | −4.9 | −9.6 | −1.1 | −3.3 | −8.1 | −4.9 | −2.7 | −6.5 | −0.5 | 0.7 |
Insomnia | −2.8 | −4.8 | −1.2 | −4.9 |
10.7
| −6.6 | 0.1 | −4.5 | 0.0 | −4.0 |
10.6
| −1.1 |
Appetite loss | −2.5 | −2.0 | −1.6 | −3.5 | 0.6 | −1.3 | −2.8 | −4.3 | −0.5 | −2.6 | −3.8 | 3.5 |
Constipation | 2.8 | 0.3 | 1.7 | 3.5 | 2.6 | −0.4 | 1.9 | −1.3 | 2.8 | 5.4 | 0.0 | 3.6 |
Diarrhoea | 0.5 | −2.1 | 3.6 | 1.7 | 8.4 | 2.1 | 0.4 | −0.9 | 5.8 | 7.7 | 0.4 | 6.5 |
Financial difficulties | −6.7 | −8.4 | −3.1 | −4.3 | 4.5 | −7.4 | −2.8 | −6.1 | −2.3 | 0.0 | −4.5 | −2.3 |