Phase 3 multicenter randomized trial of PSMA PET/CT prior to definitive radiation therapy for unfavorable intermediate-risk or high-risk prostate cancer [PSMA dRT]: study protocol

Calais, Jeremie; Zhu, Shaojun; Hirmas, Nader; Eiber, Matthias; Hadaschik, Boris; Stuschke, Martin; Herrmann, Ken; Czernin, Johannes; Kishan, Amar U.; Nickols, Nicholas G.; Elashoff, David; Fendler, Wolfgang P.

doi:10.1186/s12885-021-08026-w

Table 1 Studies evaluating several treatment regimens of RT on patients with low-, intermediate- and high-risk PCa

From: Phase 3 multicenter randomized trial of PSMA PET/CT prior to definitive radiation therapy for unfavorable intermediate-risk or high-risk prostate cancer [PSMA dRT]: study protocol

Author, year	Ref	RT type	n	total dose (Gy)	total fractions	Gy/ fraction	PFS def.	Risk group n			5-year PFS (%)
Author, year	Ref	RT type	n	total dose (Gy)	total fractions	Gy/ fraction	PFS def.	LR	IR	HR	LR	IR	HR
Kuban, 2008	[6]	3D	151	78	39	2	P	30	68	53	100	86	69
Kuban, 2008	[6]	3D	150	70	35	2	P	31	71	48	88	83	54
Al-Mamgani, 2008	[7]	3D	333	78	39	2	P	63	90	180	N/A	70	N/A
Al-Mamgani, 2008	[7]	3D	331	68	34	2	P	56	89	185	N/A	60	N/A
Zietman, 2010	[8]	3D	195	79	44	1.8	P	116	72	7	95	79	N/A
Zietman, 2010	[8]	3D	197	70	39	1.8	P	111	76	10	75	68	N/A
Dearnaley, 2007	[9]	3D	422	74	37	2	P	99	127	184	71	71	N/A
Dearnaley, 2007	[9]	3D	421	64	32	2	P	95	137	175	60	60	N/A
Michalski, 2010, 2012	[10, 11]	3D	108	68	38	1.8	P	55	37	69	68	70	42
		3D	300	74	41	1.8	P	91	75	39	73	62	62
		3D	167	79	44	1.8	P	85	54	36	67	70	70
		3D	256	74	37	2	P	92	109	40	84	74	54
		3D	220	78	39	2	P	80	109	32	80	69	67
Beckendorf, 2011	[12]	3D	153	70	35	2	P	–	153	–	–	68	–
Beckendorf, 2011	[12]	3D	153	80	40	2	P	–	153	–	–	74	–
Michalski, 2014	[13]	3D+ IMRT	748	79	44	1.8	P	–	748	–	–	75	–
		3D+ IMRT	751	70	39	1.8	P	–	751	–	–	60	–
		3D	(491)	N/A	N/A	N/A	P	30	68	53	N/A	N/A	N/A
		IMRT	(257)	N/A	N/A	N/A	P	31	71	48	N/A	N/A	N/A
Lukka, 2005	[14]	3D	470	66	33	2	A	–	470	–	N/A	53	N/A
Lukka, 2005	[14]	3D	466	52	20	2.63	A	–	466	–	N/A	60	N/A
Yeoh, 2011	[15]	3D	109	64	32	2	P	–	109	–	N/A	58	N/A
Yeoh, 2011	[15]	3D	108	55	20	2.75	P	–	108	–	N/A	69	N/A
Arcangeli, 2012	[16]	3D	85	80	40	2	P	–	–	85	N/A	N/A	79
Arcangeli, 2012	[16]	3D	83	62	20	3.1	P	–	–	83	N/A	N/A	85
Pollack, 2013	[17]	IMRT	152	76	38	2	P	–	101	51	N/A	86	86
Pollack, 2013	[17]	IMRT	151	70	26	2.7	P	–	98	53	N/A	86	86
Kuban, 2010	[18]	IMRT	102	76	42	1.8	P	30	1	1	96	96	N/A
Kuban, 2010	[18]	IMRT	102	72	30	2.4	P	30	1	1	97	97	N/A
Mantz, 2014	[19]	Gantry	102	40	5	8.0	P	40	–	–	100	N/A	N/A
Katz, 2010, 2011	[20, 21]	RA	304	35	5	7.0	P	211	81	12	99	93	75
Katz, 2010, 2011	[20, 21]	RA	304	36	5	7.3	P	211	81	12	99	93	75
Fuller, 2014	[22]	RA	60	38	4	9.5	P	40	39	–	100	92	N/A
Dubray, 2016	[23]	3D without ADT	191	80	40	2	–	–	191	–	–	76	–
Dubray, 2016	[23]	with ADT	179	80	40	2	–	–	179	–	–	84	–
Dong, 2017	[24]	3D/IMRT without ADT	979	74–80 or 70.2	40 or 26	1.8–2.7	–	–	979	–	–	87.3	–
Dong, 2017	[24]	with ADT	155	74–80 or 70.2	40 or 26	1.8–2.7	–	–	155	–	–	84	–

3D-CRT 3 dimensional conformal radiation therapy, PFS progression-free survival, HR high risk, IMRT intensity modulated radiation therapy, IR intermediate risk, LR low risk, N/A not applicable. The definition of PFS (Phoenix, P; or ASTRO A) is listed

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