Phase III Study of 18F-PSMA-1007 Versus 18F-Fluorocholine PET/CT for Localization of Prostate Cancer Biochemical Recurrence: A Prospective, Randomized, Crossover Multicenter Study

Pierre Olivier; Anne-Laure Giraudet; Andrea Skanjeti; Charles Merlin; Pierre Weinmann; Ines Rudolph; Alexander Hoepping; Mathieu Gauthé

doi:10.2967/jnumed.122.264743

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FIGURE 1.
Trial chart.
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FIGURE 2.
62-y-old patient with history of PCa (International Society of Urological Pathology grade 3; PSA level of 5.7 ng/mL), initially treated with prostatectomy (pT3N0R0), prostate bed radiation therapy, and 6 mo of androgen deprivation therapy (ADT), presenting with PSA recurrence (0.72 ng/mL). ¹⁸F-PSMA-1007 PET/CT detected pelvic lymph nodes (red arrow) and bone metastases (green arrow) that were not detected by ¹⁸F-fluorocholine PET/CT. Therapeutic management changed from targeted radiation therapy before PET to ADT after PET, leading to drop in PSA level to 0.1 ng/mL at 6 mo. BW = body weight.

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TABLE 1.

Patient Characteristics (Intention-to-Treat Population)

Characteristic	All patients (n = 190)	¹⁸F-PSMA-1007 first (n = 102)	¹⁸F-fluorocholine first (n = 88)
Median age (y)^*	69 (49–84)	68 (49–81)	70 (51–84)
Initial ISUP group grade at PCa diagnosis^†
1	29 (15.3)	12 (11.8)	17 (19.3)
2	64 (33.7)	32 (31.4)	32 (36.4)
3	55 (29.0)	33 (32.4)	22 (25)
4	14 (7.4)	8 (7.8)	6 (6.8)
5	21 (11.1)	13 (12.8)	8 (9.1)
Unknown	7 (3.7)	4 (3.9)	3 (3.4)
Prior prostatectomy^†	154 (81)	80 (78)	74 (84)
With pelvic lymph node dissection (no. of patients)	93	51	42
Serum PSA levels, in ng/mL, before first PET examination^‡
Overall	1.7 (0.6–4.2)	2.0 (0.9–5.5)	1.3 (0.6–3.1)
In patients with prior prostatectomy	1.3 (0.5–3.2)	1.7 (0.6–3.5)	0.9 (0.4–2.5)
In patients without prior prostatectomy	4.5 (2.3–9.9)	6.3 (2.8–10.9)	3.0 (2.1–9.0)
Serum PSA doubling time, in mo, before first PET examination^‡	6.3 (3–12.1)	6.4 (3.0–11.6)	5.9 (2.7–12.6)
PSA doubling time ≤ 6 mo (% of patients)	49	47	51
PSA doubling time ≤ 12 mo (% of patients)	74	76	70

↵* Values in parentheses are ranges.
↵† Reported as numbers of patients, with percentages in parentheses.
↵‡ Reported as medians, with interquartile ranges in parentheses.
ISUP = International Society of Urological Pathology.

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TABLE 2.

Patient-Level Overall Proportion of Patients With Correct Rate of Detection of Recurrent PCa According to Standard of Truth and Positive Predictive Value (ITT Population) (n = 190)

Parameter	¹⁸F-PSMA-1007^*	¹⁸F-fluorocholine^*	P
Undetermined lesions considered positive for PCa recurrence in analysis
Proportion	0.82 (0.78–0.86)	0.65 (0.60–0.71)
Difference in proportion	0.16 (0.11–0.22)		<0.0001
Odds ratio	2.40 (1.79–3.21)		<0.0001
Positive predictive value	0.96 (0.93–0.99)	0.96 (0.93–0.99)
Difference in positive predictive value	0.002 (0.031–0.035)		0.90
Odds ratio	0.95 (0.42–2.15)		0.90
Undetermined lesions considered negative for PCa recurrence in analysis
Proportion	0.77 (0.72–0.82)	0.57 (0.51–0.62)
Difference in proportion	0.21 (0.15–0.26)		<0.0001
Odds ratio	2.61 (1.97–3.46)		<0.0001
Positive predictive value	0.95 (0.92–0.99)	0.97 (0.95–1.00)
Difference in positive predictive value	0.02 (0.01–0.05)		0.25
Odds ratio	0.58 (0.22–1.55)		0.27

↵* Values in parentheses are 95% CIs.

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TABLE 3.

Patient-Level Proportion of Patients With Correct Rate of Detection of PCa Lesions by PSA Level at Baseline (ITT Population) (n = 190)

Parameter	¹⁸F-PSMA-1007^*	¹⁸F-fluorocholine^*	P
PSA < 0.5 ng/mL
No. of patients with recurrence detected by SOT = 43
Proportion	0.57 (0.45–0.68)	0.39 (0.28–0.50)
Odds radio	2.10 (1.13–3.89)		0.002
0.5 ng/mL ≤ PSA < 1.0 ng/mL
No. of patients with recurrence detected by SOT = 25
Proportion	0.83 (0.72–0.93)	0.43 (0.28–0.58)
Odds radio	6.88 (3.35–14.13)		<0.0001
1.0 ng/mL ≤ PSA < 2.0 ng/mL
No. of patients with recurrence detected by SOT = 33
Proportion	0.81 (0.72–0.89)	0.50 (0.37–0.62)
Odds radio	4.31 (2.26–8.24)		<0.0001
PSA ≥ 2.0 ng/mL
No. of patients with recurrence detected by SOT = 78
Proportion	0.85 (0.79–0.91)	0.74 (0.66–0.82)
Odds radio	2.01 (1.27–3.19)		0.003

↵* Values in parentheses are 95% CIs.
SOT = standard of truth.

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TABLE 4.

Change in Diagnostic Thinking After Both PET/CT Scans (ITT Population) (n = 190)^*

Change in diagnostic thinking	¹⁸F-fluorocholine examination contributed more	¹⁸F-PSMA-1007 examination contributed more	Both PET examinations contributed equally	Missing
Yes
PET identified site of recurrence that was not known before	3 (1.6)	80 (42.1)	29 (15.3)	3 (1.6)
PET confirmed site of recurrence that was suspected before	1 (0.5)	6 (3.2)	3 (1.6)
Other		4 (2.1)	15 (7.9)
Missing		3 (1.6)	2 (1.1)

No		38 (20)
Missing				3 (1.6)

↵* Data are reported as numbers of patients, with percentages in parentheses.

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TABLE 5.

Change in Diagnostic Thinking After Both PET Scans and Influence at End of Follow-up (ITT Population) (n = 190)^*

	Influence was:
Category	To benefit of patient	Not to benefit of patient	Neither to benefit nor disadvantage of patient	Missing
¹⁸F-fluorocholine examination contributed more
More accurate diagnosis	6 (3.2)	0	0	0
Diagnostic thinking was misled by PET	0	0	0	0
PET had no influence	0	1 (0.5)	1 (0.5)	0
Missing	0	0	0	0
¹⁸F-PSMA-1007 examination contributed more
More accurate diagnosis	88 (46.3)	2 (1.1)	10 (5.3)	2 (1.1)
Diagnostic thinking was misled by PET	1 (0.5)	1 (0.5)	2 (1.1)	0
PET had no influence	0	0	1 (0.5)	0
Missing	0	0	0	0
Both PET examinations contributed equally
More accurate diagnosis	27 (14.2)	0	13 (6.8)	0
Diagnostic thinking was misled by PET	0	5 (2.6)	1 (0.5)	0
PET had no influence	5 (2.6)	2 (1.1)	16 (8.4)	0
Missing	0	0	1 (0.5)	0
Missing
More accurate diagnosis	1 (0.5)	0	0	0
Diagnostic thinking was misled by PET	0	0	0	0
PET had no influence	0	0	0	0
Missing	0	0	0	4 (2.1)