Illuccix® has established clinical efficacy across prostate cancer stages demonstrated in pivotal trials with 68Ga-PSMA-111,a
INITIAL STAGING
Efficacy of diagnostic performance confirmed through histopathology comparison1
BIOCHEMICAL RECURRENCE
High rate of detection confirmed even at PSA levels lower than 2 ng/mL1
VARIOUS REGIONS
Demonstrated detection including bone, prostate bed, pelvic lymph node, and extrapelvic soft tissue1
National Comprehensive Cancer Network (NCCN) Guidelines and Society of Nuclear Medicine and Molecular Imaging (SNMMI) appropriate use criteria recommendations include 68Ga-PSMA-11 PET/CT or PET/MRI across different stages of prostate cancer2,3,b
a68Ga-PSMA-11 is also known as gallium Ga 68 gozetotide.
bThese guidelines do not recommend use of a particular radiopharmaceutical.
Initial Staging: PSMA-PreRP Trial
Efficacy established at initial staging1
Illuccix® accuracy demonstrated in a pivotal trial with 68Ga-PSMA-11 by histopathology comparison
The open-label, prostate-specific membrane antigen-preprostatectomy (PSMA-PreRP) study (N=325) compared majority positron emission tomography (PET) reads to pelvis lymph node histopathology results.1
In an exploratory subgroup analysis based on summed Gleason score, there was a numerical trend toward more true positives in patients with a Gleason score of ≥8 compared to those with a Gleason score of ≤7.1
In an exploratory analysis of pelvic nodal metastasis in all patients, including those without histopathology reference standard, and using an imputation method1,c:
- Imputed sensitivity was 47% (95% CI: 38%-55%)
- Imputed specificity was 74% (95% CI: 68%-80%)
Patient-Level Performance of 68Ga-PSMA-11 for Detection of Pelvic Lymph Node Metastasis (n=123)1,d

Among the pool of 6 readers, sensitivity ranged from 36% to 60%, specificity from 83% to 96%, positive predictive value from 38% to 80%, and negative predictive value from 80% to 88%.
NPV, negative predictive value; PPV, positive predictive value.
cThe imputation method was based on patient-specific factors.
dWith region matching where at least one true positive region defines a true positive patient.
e95% confidence interval (CI).
Biochemical Recurrence: PSMA-BCR-Trial
Efficacy established at biochemical recurrence even at low PSA levels1

Illuccix® provides a high rate of detection across regions as seen in a pivotal trial with 68Ga-PSMA-111
- Patients with biochemical recurrence after radical prostatectomy were enrolled in this prospective study (N=635)
- Of the 210 evaluable patients, 192 patients (91%) were found to be true positive in one or more regions against the composite reference standard (95% CI: 88%-95%)
PET results and percent PET positivity stratified by serum PSA level (n=628)1,f
Detection rates increased with increasing PSA levels.
Swipe left on table to reveal more
PSA
(ng/mL)
PET positive patients
Total
TP
FP
With reference standard
Without reference standard
PET negative patients
Percent PET positivityg (95% CI)
<0.5
48
11
1
12
36
87
36%
(27%-44%)
≥0.5 and <1
44
15
3
18
26
35
56%
(45%-67%)
≥1 and <2
71
29
1
30
41
15
83%
(75%-91%)
≥2
299
137
13
150
149
29
91%
(88%-94%)
Total
462
192
18
210
252
166
74%
(70%-77%)
TP, true positive; FP, false positive.
f7 patients were excluded from this table due to protocol deviations.
gPercent PET positivity = PET positive patients/total patients scanned.
CLR is defined as the true positive percentage among all positive PET scans1,h

In 2 exploratory analyses of gallium Ga 68 gozetotide PET positive patients without reference standard information using an imputation approach1,i
- 72% (340/475) were imputed as true positive in one or more regions (95% CI: 68%-76%)
- 54% (340/635) were correctly detected as true positive (95% CI: 50%-57%) among all BCR patients who received a PET scan, whether it was read as positive or negative
CLR, correct localization rate.
hTP/TP+FP.
fUsing an estimated likelihood that ≥1 location-matched PET positive lesion was reference standard positive based on patient-specific factors.
Illuccix® identified lesions across all vital regions as seen in a pivotal trial with 68Ga-PSMA-111,j
74% of patients (n=469) had ≥1 positive region detected by 68Ga-PSMA-11 PET majority read

jTotal does not add up to 100% due to rounding of percentages.
Guidelines
Recommendations of guidelines on PSMA PET/CT or PET/MRI
Guideline
When 68Ga-PSMA-11 is recommended for use
National Comprehensive Cancer Network (NCCN)2,k
To be considered for full body (soft tissue and bone) imaging and equivocal results on initial bone imaging at:
- Initial staging of unfavorable intermediate,l high or very high-risk prostate cancer
- Biochemical recurrence (BCR) after initial definitive therapy or progression of N1 disease on androgen deprivation therapy (ADT), or localized on observation
- Progression of nonmetastatic and metastatic castration-naïve prostate cancer
- Nonmetastatic castration-resistant prostate cancer (nmCRPC) with increasing PSA or radiographic evidence of metastases
Because of the increased sensitivity and specificity of PSMA-PET tracers for detecting micrometastatic disease compared to conventional imaging (CT, MRI) at both initial staging and BCR, the panel does not feel that conventional imaging is a necessary prerequisite to PSMA-PET and that PSMA-PET/CT or PSMA-PET/MRI can serve as an equally effective, if not more effective front-line imaging tool for these patients.
NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Society of Nuclear Medicine and Molecular Imaging (SNMMI)3,k
SNMMI appropriate use criteria (AUC) describe clinical scenarios for 68Ga-PSMA-11 PET/CT or PET/MRI use at different prostate cancer stages including:
- Newly diagnosedm unfavorable intermediate, high-risk, or very high-risk prostate cancer
- Biochemical recurrence
- nmCRPC on conventional imaging
kThese guidelines do not recommend use of a particular radiopharmaceutical.
lWith at least one of the following: 2 or 3 intermediate risk factors, Grade Group 3, ≥ 50% biopsy cores positive (ie, ≥ 6 of 12 cores).
mPatients with suspected prostate cancer evaluated for biopsy and detection of intraprostatic tumor and patients with very low, low, and favorable intermediate-risk prostate cancer are described as “rarely appropriate”.
nScoring of this indication will likely be revisited and improved based on the outcomes of radioligy and therapy clinical trials.
Guideline and when 68Ga-PSMA-11 is recommended for use
National Comprehensive Cancer Network (NCCN)2,k
To be considered for full body (soft tissue and bone) imaging and equivocal results on initial bone imaging at:
- Initial staging of unfavorable intermediate,l high or very high-risk prostate cancer
- Biochemical recurrence (BCR) after initial definitive therapy or progression of N1 disease on androgen deprivation therapy (ADT), or localized on observation
- Progression of nonmetastatic and metastatic castration-naïve prostate cancer
- Nonmetastatic castration-resistant prostate cancer (nmCRPC) with increasing PSA or radiographic evidence of metastases
Because of the increased sensitivity and specificity of PSMA-PET tracers for detecting micrometastatic disease compared to conventional imaging (CT, MRI) at both initial staging and BCR, the panel does not feel that conventional imaging is a necessary prerequisite to PSMA-PET and that PSMA-PET/CT or PSMA-PET/MRI can serve as an equally effective, if not more effective front-line imaging tool for these patients.
NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Society of Nuclear Medicine and Molecular Imaging (SNMMI)3,k
SNMMI appropriate use criteria (AUC) describe clinical scenarios for ⁶⁸Ga-PSMA-11 PET/CT or PET/MRI use at different prostate cancer stages including:
- Newly diagnosedm unfavorable intermediate, high-risk, or very high-risk prostate cancer
- Biochemical recurrence
- nmCRPC on conventional imaging
kThese guidelines do not recommend use of a particular radiopharmaceutical.
lWith at least one of the following: 2 or 3 intermediate risk factors, Grade Group 3, ≥ 50% biopsy cores positive (ie, ≥ 6 of 12 cores).
mPatients with suspected prostate cancer evaluated for biopsy and detection of intraprostatic tumor and patients with very low, low, and favorable intermediate-risk prostate cancer are described as “rarely appropriate”.
nScoring of this indication will likely be revisited and improved based on the outcomes of radioligy and therapy clinical trials.