Feasibility, pitfalls and results of a structured concept-development phase for a randomized controlled phase III trial on radiotherapy in primary prostate cancer patients

Table 1 summarizes dose prescriptions and constraints for stereotactic body radiotherapy as described in the current literature

Study/ Reference	Prescibed doses	Rectum					Urethra
Herrera et al. [38]	36.25 Gy (prostate) / 45–50 Gy (boost)	V25Gy < 20 cc		D1cc < 38 Gy	D0.1cc < 41 Gy		D1cc < 39 Gy	D0.1cc < 41
Hypo-FLAME [37]	35 Gy (prostate) / 50 Gy (boost)	V28Gy < 20%	D2cc < 35 Gy	D1cc < 38 Gy	D0.035cc < 40 Gy			D0.035cc < 42 Gy
Zelefsky et al. [41]	35–40 Gy (prostate)	V24Gy < 53%*		D1cc* < 38.5 Gy	Dmax < 41.2 Gy
PACE B [5]	36.25 Gy (prostate)	V29Gy < 20%		D1cc < 36 Gy			V42 Gy < 50%
NRG GU005 (NCT03367702)	36.25 Gy (prostate)	D0.03cc (Gy) < = 38.06	D3cc < = 34.4	D10% < =32.63	D20% < = 29	D50% < =38.06
	Acceptable	< 40	< 36	< 34	< 30	< 40
American Association of Physicits in Medicine		V25Gy < 20 cc			Dmax < 38 Gy
Study/ Reference	Bladder				Penile bulb		Small bowel
Herrera et al. [38]	Dmedian < 20 Gy		D1cc < 41 Gy	D0.1cc < 45
Hypo-FLAME [37]	V28Gy < 20%	D5cc < 37 Gy	D1cc < 42 Gy		D90% < 20 Gy		D5cc < 19.5 Gy	D0.035cc < 35 Gy
Zelefsky et al. [41]	V24Gy < 53%*	D15cc < 18.3 Gy	D1cc < 42 Gy	Dmax < 42 Gy
PACE B [5]	V18.1 Gy < 40%	D5cc < 37 Gy			V29.5 Gy < 50%			D1cc < 30 Gy
NRG GU005 (NCT03367702)	D0.03cc < =38.06	D50% < =18.12					D0.03cc < =30
	Acceptable: < 40 Gy	< 20 Gy					< 33 Gy
American Association of Physicits in Medicine		D15cc < 18.3 Gy		Dmax < 38 Gy	D3cc < 30 Gy	Dmax < 50 Gy	D5cc < 19.5 Gy	D0.035cc < 35 Gy

ISSN: 1471-2407