Randomized Trial of Prostate-Specific Membrane Antigen PET/CT Before Definitive Radiotherapy for Unfavorable Intermediate- and High-Risk Prostate Cancer (PSMA-dRT Trial)

Article Figures & Data

Download figure
Open in new tab
Download powerpoint
Download figure
Open in new tab
Download powerpoint
FIGURE 1.
CONSORT (Consolidated Standards of Reporting Trials) flow diagram.
Download figure
Open in new tab
Download powerpoint
FIGURE 2.
PFS: control and PSMA PET/CT cohorts were compared using log rank testing. Ticks represent censored cases. Patients with extrapelvic metastasis on PSMA PET/CT who were not eligible for dRT were excluded (1 patient).

TABLE 1.

Patient and Treatment Characteristics

Characteristic	Control arm	PSMA PET/CT arm
All patients^*
Median age (y)	73.6	70.7
Race
White	17 (58.6%)	16 (64.0%)
African American	2 (6.9%)	2 (8.0%)
Other	10 (34.5%)	7 (28.0%)
NCCN risk group
Unfavorable intermediate risk	14 (48.3%)	11 (44.0%)
High risk	15 (51.7%)	14 (56.0%)
Median initial PSA (ng/mL)	8.4 (IQR, 4.9–20.5)	10.7 (IQR, 6.4–12.9)
Gleason score
≤7	18 (62.1%)	13 (52.0%)
8	5 (17.2%)	4 (16.0%)
9–10	6 (20.7%)	8 (32.0%)
T stage by conventional imaging
T1–2	25 (86.2%)	20 (80.0%)
T3–4	4 (13.8%)	5 (20.0%)
N stage by conventional imaging
N0/Nx	27 (93.1%)	23 (92.0%)
N1	2 (6.9%)	2 (8.0%)
Conventional imaging performed
CT	1 (3.4%)	1 (4.0%)
MRI	8 (27.6%)	7 (28.0%)
CT and MRI	3 (10.3%)	2 (8.0%)
Bone scan and CT	1 (3.4%)	1 (4.0%)
Bone scan and MRI	0 (0%)	3 (12.0%)
Bone scan, CT, and MRI	11 (37.9%)	10 (40.0%)
¹⁸F-fluciclovine PET and MRI	4 (13.8%)	0 (0%)
¹⁸F-fluciclovine PET, MRI, bone scan, and CT	1 (3.4%)	0 (0%)
¹⁸F-fluciclovine PET, bone scan, and CT	0 (0%)	1 (4.0%)
Patients included in primary endpoint analysis^†
Concurrent ADT	21 (75.0%)	18 (75%)
Pelvic lymph node irradiation	7 (25.0%)	8 (33.3%)
PSMA PET/CT miTNM stage	—
miT2bN0M0		10 (41.7%)
miT2cN0M0		4 (16.7%)
miT3aN0M0		4 (16.7%)
miT3bN0M0		2 (8.3%)
miT3aN1M0		3 (12.5%)
miT3bN1M1b		1 (4.2%)

↵* All patients in the study (n = 29 patients in the control arm and 25 patients in the PSMA PET/CT arm).
↵† Patients included in primary endpoint analysis (n = 28 patients in the control arm and 24 patients in the PSMA PET/CT arm).
NCCN = National Comprehensive Cancer Network; PSA = prostate-specific antigen; IQR = interquartile range; ADT = androgen deprivation therapy.
Data are number and percentage unless otherwise indicated.