The ProCaSP Study

Quality of Life Outcomes of Prostate Cancer Patients After Radiotherapy or Radical Prostatectomy in a Cohort Study

Nora Eisemann; Sandra Nolte; Maike Schnoor; Alexander Katalinic; Volker Rohde; Annika Waldmann

BMC Urol. 2015;15(28)

Conclusions

Our results support the findings from previous research. A fundamental basis of both empirical research and evidence-based medicine is the reproducibility of findings in different settings, health care systems, and different cohorts of patients. In conclusion, RT cancer patients scored lowest on HRQOL at baseline and throughout the study. RP had a larger negative impact on sexual functioning than RT. In patients with similar baseline characteristics and similar baseline HRQOL, treatment by RT increased symptoms of diarrhoea, and nnsRP decreased prostate-specific HRQOL. In view of the relevant proportion of overdiagnosis in prostate cancer and in view of improved survival rates for prostate cancer patients, physicians should inform their patients about these differences in HRQOL outcomes and take them into account when deciding which therapy is best for an individual patient.

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Abbreviations
brachyRT: Brachytherapy, combRT: Combined extern radiotherapy and brachytherapy, externRT: Extern radiotherapy, HRQOL: Health-related quality of life, nnsRP: Non-nerve-sparing radical prostatectomy, nsRP: Nerve-sparing radical prostatectomy, RP: Radical prostatectomy, RT: Radiotherapy, SD: Standard deviation

Competing interests
The authors declare that they have no competing interests.

Authors' contributions
NE made substantial contributions to the design of the analysis, to the statistical analysis and interpretation, and to drafting the manuscript. SN made substantial contributions to drafting the manuscript and to revising it critically for important intellectual content. MS contributed to the statistical analysis and to drafting the manuscript. AK made substantial contributions to drafting the manuscript and to revising it critically for important intellectual content. VR planned the study and was involved in data acquisition and revised the manuscript for important intellectual content. AW contributed to the planning of the analysis, to the statistical analysis, interpretation of results, and drafting the manuscript. All authors gave final approval of the final manuscript.

Acknowledgements
We thank the German Cancer Aid for funding the ProCaSP Study.

Table 1. Sociodemographic characteristics and tumor specific data
	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	0.110
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	-	0.032
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	<0.001

¹Chi-square and F- test for the three groups (non-nerve-sparing radical prostatectomy, nerve-sparing radical prostatectomy, and total radiotherapy), respectively.

Table 2. Estimated effect of treatment option on HRQOL in a multiple regression analysis
	Main analysis						Analysis with separation of different RT treatment groups¹						Wald test
	Radical prostatectomy			Radiotherapy		Wald test	Radiotherapy						Wald test
	Ref.	Nerve-sparing		Total		p-value	Brachytherapy		Combined (External/brachytherapy)		External		p-value
	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

Ref = Non-nerve-sparing radical prostatectomy as reference level.
Bold values indicate significance at the 5%-level.
¹As the regression coefficients of the radical prostatectomy group did not change much, only the regression coefficients of the radiotherapy subgroups with their confidence intervals and the Wald test p-values are reported.
Both analyses are adjusted for baseline HRQOL, age, having a partner (yes/no), highest education level (no graduation, 8–9 years ('Hauptschulabschluss'), 10–11 years ('Realschulabschluss'), >= 12 years high school ('(Fach-)Abitur')), working (yes/no), residence (rural/urban), tumour stage (T-category of the TNM-classification), pre-therapeutic Gleason score, pre-therapeutic PSA score, and sexual functioning at baseline (IIEF total scale).

Table 3. Differences between EORTC QLQ-C30 ProCaSP data and norm data
	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

Legend: positive differences = higher mean functioning or higher mean symptom score in the prostate cancer patient group than in the norm data, negative differences = lower mean functioning or higher mean symptom score in the prostate cancer patient group than in the norm data.
Bold numbers indicate clinical relevance.
nns = non-nerve-sparing, ns = nerve-sparing, brachy = brachytherapy, extern = extern radiotherapy, comb = extern radiotherapy and brachytherapy.

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