Illuccix (68Ga-PSMA-11) has extensive clinical experience across a broad range of disease burden.
68Ga-PSMA-11a (Illuccix) is recommended by AUA/SUO, National Comprehensive Cancer Network® (NCCN®) and SNMMI/EANM procedure guidelines2-4
a68Ga-PSMA-11 is also known as gallium Ga 68 gozetotide.
Initial Staging: PSMA-PreRP Trial
Proven diagnostic performance even for micrometastatic disease1,4-7
68Ga-PSMA-11 (Illuccix) can provide early and accurate tumor detection for patients with a broad range of disease burden1
The PSMA-PreRP trial was an open-label study of patients with biopsy-proven prostate cancer who were considered candidates for prostatectomy and pelvic lymph node dissection (N=325).1
Patient-Level Performance of 68Ga-PSMA-11 for Detection of Pelvic Lymph Node Metastasis (n=123)1,b
The pivotal PSMA-PreRP trial included patients with either intermediate- or high-risk disease, determined by at least one of the following8:
- Elevated PSA level ≥10 ng/mL
- T-stage ≥T2b
- Gleason score ≥6
NPV, negative predictive value; PPV, positive predictive value.
bBy histopathology comparison, with region matching where at least one true positive region defines a true positive patient.1
c95% confidence interval (CI).1
Biochemical Recurrence: PSMA-BCR-Trial
Accurate detection of prostate cancer across a broad patient population at the initial signs of BCR1
Detect prostate cancer even at PSA levels <2 ng/mL with a consistently high CLR1
The pivotal PSMA-BCR trial was a prospective 2-center study of patients with biochemical evidence of recurrent prostate cancer after definitive therapy (N=635).1
Correct localization rate (CLR) by serum PSA level1
The pivotal PSMA-BCR trial included patients who1:
- had a wide range of PSA levels:
- 48% had PSA levels <2 ng/mL
- 52% had PSA levels ≥2 ng/mL
- had received standard definitive therapy:
- 64% received radical prostatectomies
- 73% received radiotherapy treatment
CLR is defined as the true positive percentage among all positive PET scans with a reference standardd
Achieve high true positive rates in the detection of regional and distant metastases, including bone, with Illuccix1
192 of the 210 evaluable patients (91%) were found to be true positive in ≥1 regions against the composite reference standard (95% Cl: 85%-95%).1
74% of patients (n=469) had ≥1 positive region detected by 68Ga-PSMA-11 PET majority read1
dTP/TP+FP.
eTotal does not add up to 100% due to rounding of percentages.
Patient Selection for PSMA-directed 177Lu Radioligand Therapy: VISION Trial
Confidence in guiding treatment decisions with Illuccix1,9-12
Illuccix combines the accuracy of 68Ga-PSMA-11 PET imaging with the reliable and flexible distribution network of Telix1,9-12,f
In the Phase 3 VISION trial, 68Ga-PSMA-11 PET imaging was performed to determine eligibility of mCRPC patients for PSMA-directed ¹⁷⁷Lu radioligand therapy (N=1003).1
Patient eligibility for PSMA-directed 177Lu radioligand therapy evaluated by the central reader1:
869 patients were
PSMA-positive1,g
126 patients were
PSMA-negative1
Confirm if PSMA-directed 177Lu radioligand therapy is appropriate for your patients with mCRPC
fFor patient selection, interpret ILLUCCIX PET in conjunction with patients’ clinical history and imaging from other modalities, including diagnostic anatomical imaging in clinically relevant regions, such as chest, abdomen, and pelvis.1
gDefined as patients having ≥1 tumor lesion with 68Ga-PSMA-11 uptake greater than normal liver and all tumor lesions larger than size criteria with 68Ga-PSMA-11 uptake greater than liver [short axis size criteria: organs ≥1 cm, lymph nodes ≥2.5 cm, bones (soft tissue component) ≥1 cm].1
Guidelines
Recommendations of guidelines on PSMA PET/CT or PET/MRI
Recommended clinical use & application
NCCN
SNMMI/EANM
AUA/SUO
Initial staging for suspected metastases2-4
BCR based on elevated PSA2-4
nmCRPC with elevated PSA2-4
Monitoring for progression in advanced prostate cancer2-4
Eligibility for PSMA-directed radioligand therapy2-4
Recommended clinical use & application
NCCN
Initial staging for suspected metastases2-4
BCR based on elevated PSA2-4
nmCRPC with elevated PSA2-4
Monitoring for progression in advanced prostate cancer2-4
Eligibility for PSMA-directed radioligand therapy2-4
Recommended clinical use & application
SNMMI/
EANM
Initial staging for suspected metastases2-4
BCR based on elevated PSA2-4
nmCRPC with elevated PSA2-4
Monitoring for progression in advanced prostate cancer2-4
Eligibility for PSMA-directed radioligand therapy2-4
Recommended clinical use & application
AUA/SUO
Initial staging for suspected metastases2-4
BCR based on elevated PSA2-4
nmCRPC with elevated PSA2-4
Monitoring for progression in advanced prostate cancer2-4
Eligibility for PSMA-directed radioligand therapy2-4
Guideline
When 68Ga-PSMA-11 PET/CT or PET/MRI is recommended for use
NCCN Guidelines®4
Preferred and category 2A recommendationh
To be considered for full body (soft tissue and bone) imaging and equivocal results on initial bone imaging at:
- Initial staging of unfavorable intermediate,i 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 progression of localized disease 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
- Eligibility of candidates for PSMA-directed radioligand therapy
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) and European Association of Nuclear Medicine (EANM)2,j
SNMMI appropriate use criteria (AUC) describes scenarios where 68Ga-PSMA-11 PET/CT or PET/MRI may be used in a clinical setting based on an appropriateness score categorized as “appropriate,” “may be appropriate,” or “rarely appropriate.” Below are the scenarios and stages deemed as “appropriate”:
- Newly diagnosedk unfavorable intermediate, high-risk, or very high-risk prostate cancer
- Biochemical recurrence
- nmCRPC on conventional imaging
- Evaluation of eligibility for patients being considered for PSMA-targeted radioligand therapy
American Urological Association (AUA) and Society of Urologic Oncology (SUO)3
AUA/SUO recommend use of 68Ga-PSMA-11 PET imaging across prostate cancer stages, including:
- Newly diagnosed patients with aggressive cancer defined by D’Amico risk factors (T-stage ≥cT3a, Grade Group 4/5, or PSA >20 ng/mL)
- Preferred imaging methodl for periodic staging of patients with non-metastatic BCR after failure of local therapy who are at high risk for metastases (eg, PSA doubling time <12 months)
- Assessment of patients with nmCRPC every 6-12 months for development of metastatic disease
- Assessment of patients with mCRPC at least annually without PSA progression or new symptoms
- Patients with mCRPC who received prior docetaxol and androgen pathway inhibitor, and considering PSMA-directed radioligand therapy
Expert Opinion: Clinicians should utilize PSMA PET imaging preferentially, where available, in patients with PSA recurrence after failure of local therapy as an alternative to conventional imaging due to its greater sensitivity, or in the setting of negative conventional imaging.
Guideline and when 68Ga-PSMA-11 is recommended for use
NCCN Guidelines®4
Preferred and category 2A recommendationh
To be considered for full body (soft tissue and bone) imaging and equivocal results on initial bone imaging at:
- Initial staging of unfavorable intermediate,i 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 progression of localized disease 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
- Eligibility of candidates for PSMA-directed radioligand therapy
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) and European Association of Nuclear Medicine (EANM)2,j
SNMMI appropriate use criteria (AUC) describes scenarios where 68Ga-PSMA-11 PET/CT or PET/MRI may be used in a clinical setting based on an appropriateness score categorized as “appropriate,” “may be appropriate,” or “rarely appropriate.” Below are the scenarios and stages deemed as “appropriate”:
- Newly diagnosedk unfavorable intermediate, high-risk, or very high-risk prostate cancer
- Biochemical recurrence
- nmCRPC on conventional imaging
- Evaluation of eligibility for patients being considered for PSMA-targeted radioligand therapy
American Urological Association (AUA) and Society of Urologic Oncology (SUO)3
AUA/SUO recommend use of 68Ga-PSMA-11 PET imaging across prostate cancer stages, including:
- Newly diagnosed patients with aggressive cancer defined by D’Amico risk factors (T-stage ≥cT3a, Grade Group 4/5, or PSA >20 ng/mL)
- Preferred imaging methodl for periodic staging of patients with non-metastatic BCR after failure of local therapy who are at high risk for metastases (eg, PSA doubling time <12 months)
- Assessment of patients with nmCRPC every 6-12 months for development of metastatic disease
- Assessment of patients with mCRPC at least annually without PSA progression or new symptoms
- Patients with mCRPC who received prior docetaxol and androgen pathway inhibitor, and considering PSMA-directed radioligand therapy
Expert Opinion: Clinicians should utilize PSMA PET imaging preferentially, where available, in patients with PSA recurrence after failure of local therapy as an alternative to conventional imaging due to its greater sensitivity, or in the setting of negative conventional imaging.
hBased upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.4
iWith at least one of the following: 2 or 3 intermediate risk factors, Grade Group 3, ≥ 50% biopsy cores positive (ie, ≥ 6 of 12 cores).4
jThese guidelines do not recommend use of a particular radiopharmaceutical.
kPatients 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”.13
lWith or without CT, MRI, or technetium bone scan.
Detection of benign bone lesions with 18F-based PSMA radiotracers
Interpreting benign lesions as metastatic may have far reaching implications for patients.14
SNMMI procedure guidelines and other studies suggest interpreting bone lesions with 18F-based PSMA radiotracers can be challenging due to detection of benign bone lesions.2,14-16
Undesired accumulation of free 18F in bone may result in false positives17
Detection of benign bone lesions with 18F-based PSMA radiotracers may be due to the high affinity of free 18F for bone. Free 18F load can be associated with radiodefluorination, a key process for 18F-based PSMA radiotracer metabolism that produces additional free 18F.17
