Morbidity and quality of life during thermotherapy using magnetic nanoparticles in locally recurrent prostate cancer: Results of a prospective phase I trial

Figures & data

Table I.  Patient characteristics.

Patient	Age	Previous treatments (chronological order)	Initial stage^a	Initial Grade^a	Initial PSA (ng/ml)^a	PSA (ng/ml)^b	Gleason sum^b
1	67	HDR brachytherapy + Ext. Hormonal therapy	T2	G2	15.5	19.1	8
2	68	Hormonal therapy HDR brachytherapy + Ext.	T3	G2	40.7	6.4	7
3	64	Radical prostatectomy External radiation  Hormonal therapy	T3	G2	8.3	0.8	6
4	70	HDR brachytherapy + Ext.	T1	G2	8.0	2.2	7
5	62	LDR brachytherapy + Ext.	T3	G2	27.0	7.1	6
6	68	External radiation Hormonal therapy	T1	G2	5.6	2.8	6
7	65	External radiation Hormonal therapy	T3	G2	16.1	3.0	7
8	75	Suprapubic prostatectomy External radiation Hormonal  therapy Regional hyperthermia TURP	T1	G2	10.6	5.9	8
9	73	Radical prostatectomy External radiation  Hormonal therapy Chemotherapy	T3	G2	11.3	13.8	8
10	79	TURP LDR brachytherapy External radiation  + Regionalhyperthermia Hormonal therapy	T1	G1	5.7	8.9	8

PSA: prostate-specific antigen; HDR: high dose rate; LDR: low dose rate. Ext.: External radiation; TURP: transurethral resection of the prostate; ^aAt first diagnosis; ^bBaseline results before starting thermotherapy.

Figure 1. Example of an unenhanced computed tomography scan obtained one year after a single injection of magnetic fluid into the prostate, followed by six thermotherapy sessions (left). Hyperdense nanoparticle deposits in the prostate are still clearly visible. Histology image obtained by prostate biopsy of the same patient 1 year after treatment (right). Iron-oxide nanoparticles (brown) are still present in the prostate tissue (hematoxylin-eosin staining, ×200).

Table II.  Evaluation of changes in quality of life (QoL) over time. Measurements were carried out before thermotherapy (baseline), at mid-treatment (week 3), at the end of thermotherapy (week 6) and after 3 and 6 months.

		← Thermotherapy →
	Baseline	Week 3	p	Week 6	p	Month 3	p	Month 6	p
EORTC-QLQ-C30
Physical functioning	89.0 (11.0)	84.0 (13.0)	ns	83.3 (20.4)	ns	88.7 (6.3)	ns	87.3 (9.6)	ns
Role functioning	85.0 (18.3)	63.4 (17.2)	<0.05	60.0 (27.4)	<0.01	85.0 (14.6)	ns	85.0 (16.6)	ns
Emotional functioning	79.7 (14.6)	76.3 (14.9)	ns	69.3 (12.7)	ns	84.7 (15.7)	ns	83.3 (14.0)	ns
Cognitive functioning	86.7 (21.9)	78.3 (17.6)	ns	80.0 (15.3)	ns	81.7 (21.4)	ns	76.7 (19.6)	ns
Social functioning	91.7 (14.1)	75.0 (11.8)	<0.05	61.7 (13.7)	<0.01	73.3 (14.0)	<0.01	76.7 (16.1)	<0.05
Global health status/QoL	66.7 (13.0)	56.7 (17.0)	ns	60.8 (13.1)	ns	65.8 (12.1)	ns	64.2 (11.8)	ns
Fatigue	21.3 (18.0)	42.3 (13.7)	<0.05	39.0 (16.4)	ns	24.7 (22.4)	ns	25.0 (17.2)	ns
Nausea and vomiting	1.7 (5.3)	1.7 (5.3)	ns	5.0 (11.2)	ns	3.3 (10.5)	ns	3.3 (10.5)	ns
Pain	15.0 (27.7)	43.3 (33.5)	<0.05	36.7 (31.2)	ns	13.3 (21.9)	ns	15.0 (21.4)	ns
Dyspnoe	10.0 (16.1)	13.3 (17.2)	ns	10.0 (16.1)	ns	16.7 (17.6)	ns	16.7 (17.6)	ns.
Insomnia	26.7 (26.3)	36.6 (29.2)	ns	33.3 (22.2)	ns	33.3 (38.5)	ns	33.3 (38.5)	ns
Appetite loss	0.0 (0.0)	13.3 (23.3)	ns	6.7 (14.0)	ns	10.0 (22.5)	ns	10.0 (16.1)	ns
Constipation	6.7 (14.0)	20.0 (35.8)	ns	13.3 (32.2)	ns	10.0 (22.5)	ns	6.7 (14.0)	ns
Diarrhoea	10.0 (16.1)	19.9 (17.2)	ns	23.3 (31.6)	ns	16.7 (17.6)	ns	10.0 (16.1)	ns
Financial difficulties	13.3 (23.3)	13.3 (23.3)	ns	33.3 (35.1)	<0.01	10.0 (22.5)	ns	13.3 (23.3)	ns
EORTC-QLQ-PR25
Urinary symptoms	32.0 (20.8)	49.0 (14.0)	<0.05	41.0 (15.4)	ns	36.3 (18.1)	ns	31.6 (19.2)	ns
Bowel-related symptoms	10.4 (8.5)	14.3 (12.0)	ns	11.7 (12.3)	ns	6.3 (10.2)	ns	5.0 (7.2)	ns
Treatment-related sympt.	15.3 (9.3)	11.7 (6.7)	ns	12.0 (5.9)	ns	14.0 (11.2)	ns	11.3 (9.2)	ns
Sexual functioning	26.7 (25.7)	10.0 (22.5)	<0.01	14.3 (22.9)	<0.05	16.7 (21.3)	ns	17.7 (22.3)	ns
Sexual activity	47.7 (17.4)	42.7 (14.7)	ns	42.3 (23.2)	ns	46.0 (17.5)	ns	46.0 (16.9)	ns

Values are given as mean scores (standard deviation). The p values indicate significance of the differences compared to baseline scores. The means of intraindividual differences regarding each parameter were considered. Functional scales are indicated in italic. EORTC-QLQ-C30: cancer-specific European Organization for Research and Treatment of Cancer core questionnaire; EORTC-QLQ-P25: tumor-specific EORTC prostate cancer module; ns: not significant.