INDICATIONS AND USAGE

GOZELLIX, after radiolabeling with Ga-68, is for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:
  • With suspected metastasis who are candidates for initial definitive therapy
  • With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level

Performance

PSMA imaging is guideline supported across the many stages of prostate cancer

Guidelines underscore a substantial need

Prostate cancer is diagnosed in nearly 314,000 men annually and represents the second-leading cause of cancer death among men in the United States.1

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) do not recommend conventional imaging as a prerequisite to PSMA PET.2

Recommendations of guidelines on PSMA PET/CT or PET/MRI2-4

Recommended clinical use & application
NCCN
SNMMI/EANM
AUA/SUO
Initial staging for
suspected metastases
BCR based on elevated PSA
nmCRPC with elevated PSA
More info
See how Gozellix® works
Actor portrayal of a veteran with prostate cancer.

PSMA PET scans are under-utilized among US veterans and other high-risk populations

Despite evidence-based recommendations, ≈1/3 of men in the Veterans Health Administration with newly diagnosed high-risk prostate cancer (Gleason scores 8-10 and PSA >20 ng/mL) are not receiving PSMA PET2,5

In a study of disparities in imaging, black patients were found to receive nearly 4 times fewer 68Ga-PSMA-11a PET scans than non-Hispanic white patients6

a68Ga-PSMA-11 is also known as gallium Ga-68 gozetotide.

PSMA PET provides accurate imaging critical for clinical decision-making

The standard of care for advanced prostate cancer imaging7

PSMA PET is increasingly replacing conventional imaging for many phases of prostate cancer because it provides more accurate information.3

Picture representing the effectiveness of PSMA PET scans.

Imaging modality performance in the proPSMA study conducted in high-risk prostate cancer patients8,b

PSMA-PET/CT
Conventional imagingc
Difference
Favors PSMA
Sensitivity
(metastases)
85%
38%
47%
Specificity
(metastases)
98%
91%
7%
Accuracy in pelvic lymph node metastases
91%
59%
32%
Uncertain results
7%
23%
16%
Radiation exposure
8.4 mSv
19.2 mSv
10.9 mSv
b
A multicenter, two-arm, randomized trial of high-risk men ≥18 years of age (N=302) with histopathologically confirmed prostate cancer being considered for radical prostatectomy or radiotherapy with curative intent at 10 Australian centers. Patients had a PSA of ≥20 ng/mL within 12 weeks before randomization, an ISUP grade group 3–5, or clinical stage T3 or worse.8
c
Abdominal CT + bone scan.

PSMA PET/CT often changes patient management

In a meta-analysis of 54 studies, PSMA PET/CT led to changes in clinical management in9:

28%
of cases with primary prostate cancer
54%
of cases with recurrent disease

Start strong with accurate initial staging

Receive more information.

Performance—initial staging/diagnosis

Proven diagnostic performance for early and accurate metastases detection at initial staging.

Reliable diagnostic performance of 68Ga-PSMA-11a for detecting pelvic lymph node metastases10

Gozellix provides confidence in evaluating for the presence of pelvic lymph node metastases with 90% specificity and 84% negative predictive value10
Scan of 69-year-old man diagnosed with adenocarcinoma of the prostate.
69- year-old man diagnosed with adenocarcinoma of the prostate. Gleason score 4+5. PSA 21 ng/mL.
Ga-68 gozetotide 5.8 mCi, 59-minute uptake period: Primary tumor confirmed in the left lobe. Lumbar spine metastasis detected, confirming state IV prostate cancer diagnosis.11

Patient-level performance of 68Ga-PSMA-11 for detection of pelvic lymph node metastasis (n=123)d

Diagnostic performance10
Diagnostic performance shows 90% specificity and 47% sensitivity.
Predictive value10
Predictive value of 84% NPV and 61% PPV.
a
68Ga-PSMA-11 is also known as gallium Ga-68 gozetotide.
d
By histopathology comparison, with region matching where at least one true positive region defines a true positive patient.10
e
95% confidence interval (CI).10

Gozellix scans provide information critical to patient management12

69% of patients were restaged.
57% of patients had management changes.

Gozellix enables accurate detection of micrometastases as small as 2 mm for more informed clinical decision-making at the earliest signs across a broad range of prostate cancer13,14

68Ga-PSMA-11 has been used in more than 220,000 patients15

Performance—biochemical recurrence

Reliable, accurate results for patients with recurrent prostate cancer

Accurate detection of prostate cancer across a broad patient population at the initial signs of biochemical recurrence (BCR)10
In a retrospective follow-up analysis of treatment decisions for patients with BCR who received 68Ga-PSMA-11 PET/CT for restaging (N=203)­16:
60% of patients had a change in management. Of the patients who had treatment changes: 45% had complete responses.
CLR by serum PSA level
CLR is defined as the true positive percentage among all positive PET scans with reference standard.10,f
<0.5 PSA level with a CLR of 92%. ≥0.5 and <1 PSA level with a CLR of 83%. ≥1 and <2 PSA level with a CLR of 97%. ≥2 PSA level with a CLR of 91%.
fTP/TP+FP.


Detection rates of distant metastases increased with PSA levels17

  • High true positive rates in regional and distant metastases, including bone18
  • 91% true positive rate10

Gozellix demonstrated high accuracy in recurrent prostate cancer detection (N=2005)17

A prospective, multicenter study of 68Ga-PSMA-11 hybrid PET performed on patients at the time of biochemically recurrent prostate cancer after radical prostatectomy (RP), definitive radiation therapy (RT), or RP with postoperative RT. The primary study endpoint was the PPV of 68Ga-PSMA-11 PET/CT.17

Detection in patients with PSA levels as low as 0.02 ng/mL18

Putative local recurrence in a 71-year-old man with 0.10 ng/mL PSA.18
Putative left iliac lymph node metastasis in a 67-year-old man with 0.13 ng/mL PSA.18
Adapted from Burgard C, et al,18 under the terms and conditions of the Creative Commons Attribution (CC BY) license.
a68Ga-PSMA-11 is also known as gallium Ga-68 gozetotide.

Take a closer look at 68Ga-PSMA-11a

68Ga-PSMA PET scan19
68Ga-PSMA-11 shows no suspicious findings.
Scan shows no suspicious findings, saving time for both the HCP and patient.
Seifert R, Telli T, Opitz M, et al. Unspecific 18F-PSMA-1007 bone uptake evaluated through PSMA-11 PET, bone scanning, and MRI triple validation in patients with biochemical recurrence of prostate cancer. J Nucl Med. 2023;64(5):738-743; Fig 1.

PSMA PET tracers exhibit differential biodistribution that can impact interpretation and clinical decision-making20

  • Gozellix has the longest time to dose expiration of any 68Ga-based PET agent that incorporates cyclotron-based Ga-6810

68Ga-PSMA-11 had a lower rate of unspecific bone uptake than those scanned with 18F-PSMA-1007 PET21,22

Interpreting benign lesions as metastatic may have far-reaching implications for patients.23

Society of Nuclear Medicine and Molecular Imaging (SNMMI) procedure guidelines and studies suggest interpreting bone lesions with 18F-based PSMA radiotracers could have significant implications due to detection of benign bone lesions.3,22-24

68Ga has high interobserver agreement7

Detection in patients with PSA levels as low as 0.02 ng/mL18

  • 68Ga-PSMA-11 PET/CT has high reproducibility and higher interobserver agreement than 18F-based scans7,25

68Ga has low interobserver variability25

Low incidence of bladder accumulation, particularly when given with hydration and/or a diuretic. Voiding is recommended prior to imaging to reduce tracer accumulation.10,26

Gozellix has an injection window of more than 3X that of 18F-based tracers at standard dose27

a
68Ga-PSMA-11 is also known as gallium Ga-68 gozetotide.
g
Based on median of recommended dosing range in the Prescribing Information.
AUA, American Urological Association; BCR, biochemical recurrence; CLR, correct localization rate; CT, computed tomography; EANM, European Association of Nuclear Medicine; HCP, healthcare professional; ISUP, International Society of Uropathology; MRI, magnetic resonance imaging; NCCN, National Comprehensive Cancer Network; nmCRPC, non-metastatic castration-resistant prostate cancer; NPV, negative predictive value; PET, positron emission tomography; PPV, positive predictive value; PreRP, preprostatectomy; PSA, prostate-specific antigen; PSMA, prostate-specific membrane antigen; SUO, Society of Urologic Oncology.

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INDICATIONS AND USAGE

GOZELLIX, after radiolabeling with Ga-68, is for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:
  • With suspected metastasis who are candidates for initial definitive therapy
  • With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Risk for Misinterpretation
Image interpretation errors can occur with GOZELLIX PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga-68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.
Imaging Prior to Initial Definitive or Suspected Recurrence Therapy
The performance of GOZELLIX for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of GOZELLIX for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score.
Radiation Risks
Gallium Ga-68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration.
Hypersensitivity Reactions to Sulfites
Ascorbic Acid Stabilizer contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

ADVERSE REACTIONS

The safety of gallium Ga-68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMA-BCR studies, each receiving one dose of gallium Ga-68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%.

DRUG INTERACTIONS

Androgen deprivation therapy and other therapies targeting the androgen pathway

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga-68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga-68 gozetotide PET has not been established.

Please note that this information is not comprehensive.

Please see the Full Prescribing Information.

You are encouraged to report suspected adverse reactions of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report adverse reactions to Telix Pharmaceuticals (US) by calling 1-844-455-8638 or emailing pharmacovigilance@telixpharma.com.

References: 1. Prostate cancer facts and statistics. ZERO Prostate Cancer. Accessed February 10, 2025. https://zerocancer.org/about-prostate-cancer/facts-statistics. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.2.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed April 16, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. 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. 3. Fendler WP, Eiber M, Beheshti M, et al. PSMA PET/CT: joint EANM procedure guideline/SNMMI procedure standard for prostate cancer imaging 2.0. Eur J Nucl Med Mol Imaging. 2023;50(5):1466-1486. 4. Lowrance W, Dreicer R, Jarrard DF, et al. Updates to advanced prostate cancer: AUA/SUO guideline (2023). J Urol. 2023;209(6):1082-1090. 5. Miller SR, Gonzalez RT, Jackson WC, et al. Rates of PSMA PET staging and positivity in newly diagnosed prostate cancer in a national health care system. J Nucl Med. 2025;66(1):75-83. 6. Bucknor MD, Lichtensztajn DY, Lin TK, Borno HT, Gomez SL, Hope TA. Disparities in pet imaging for prostate cancer at a tertiary academic medical center. J Nucl Med. 2021;62(5):695-699. 7. Bundschuh RA, Lütje S, Bundschuh L, et al. High interobserver agreement on PSMA PET/CT even in the absence of clinical data. Clin Nucl Med. 2023;48(3):207-212. 8. Hofman MS, Lawrentschuk N, Francis RJ, et al; proPSMA Study Group Collaborators. Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multi-centre study. Lancet. 2020;395(10231):1208-1216. 9. Jeet V, Parkinson B, Song R, Sharma R, Hoyle M. Histopathologically validated diagnostic accuracy of PSMA-PET/CT in the primary and secondary staging of prostate cancer and the impact of PSMA-PET/CT on clinical management: a systematic review and meta-analysis. Semin Nucl Med. 2023;53(5):706-718. 10. Gozellix (kit for the preparation of gallium Ga 68 gozetotide injection) prescribing information. 11. Data on File. 68-GA Imaging. Telix Pharmaceuticals. 2025. 12. Sonni I, Eiber M, Fendler WP, et al. Impact of 68Ga-PSMA-11 PET/CT on staging and management of prostate cancer patients in various clinical settings: a prospective single-center study. J Nucl Med. 2020;61(8):1153-1160. 13. Giesel FL, Fiedler H, Stefanova M, et al. PSMA PET/CT with Glu-urea-Lys-(Ahx)-[68Ga(HBED-CC)] versus 3D CT volumetric lymph node assessment in recurrent prostate cancer. Eur J Nucl Med Mol Imaging. 2015;42(12):1794-1800. 14. Alipour R, Azad A, Hofman MS. Guiding management of therapy in prostate cancer: time to switch from conventional imaging to PSMA PET? Ther Adv Med Oncol. 2019;11:1758835919876828. 15. Data on File. Internal Telix Sales. Telix Pharmaceuticals. 2025. 16. Müller J, Ferraro DA, Muehlematter UJ, et al. Clinical impact of 68Ga-PSMA-11 PET on patient management and outcome, including all patients referred for an increase in PSA level during the first year after its clinical introduction. Eur J Nucl Med Mol Imaging. 2019;46(4):889-900. 17. Abghari-Gerst M, Armstrong WR, Nguyen K, et al. A comprehensive assessment of 68Ga-PSMA-11 PET in biochemically recurrent prostate cancer: results from a prospective multicenter study on 2,005 patients. J Nucl Med. 2022;63(4):567-572. 18. Burgard C, Hoffmann MA, Frei M, et al. Detection efficacy of 68Ga-PSMA-11 PET/CT in biochemical recurrence of prostate cancer with very low PSA levels: a 7-year, two-center “real-world” experience. Cancers (Basel). 2023;15(5):1376. 19. Seifert R, Telli T, Opitz M, et al. Unspecific 18F-PSMA-1007 bone uptake evaluated through PSMA-11 PET, bone scanning, and MRI triple validation in patients with biochemical recurrence of prostate cancer. J Nucl Med. 2023;64(5):738-743. 20. Heilinger J, Roth KS, Weis H, et al. Do you know your PSMA-tracer? Variability in the biodistribution of different PSMA ligands and its potential impact on defining PSMA-positivity prior to PSMA-targeted therapy. EJNMMI Res. 2025;15(1):4. 21. Kuchar M, Mamat C. Methods to increase the metabolic stability of 18F-radiotracers. Molecules. 2015;20(9):16186-16220. 22. Rauscher I, Krönke M, König M, et al. Matched-pair comparison of 68Ga-PSMA-11 PET/CT and 18F-PSMA-1007 PET/CT: frequency of pitfalls and detection efficacy in biochemical recurrence after radical prostatectomy. J Nucl Med. 2020;61(1):51-57. 23. Phelps TE, Harmon SA, Mena E, et al. Predicting outcomes of indeterminate bone lesions on 18F-DCFPyL PSMA PET/CT scans in the setting of high-risk primary or recurrent prostate cancer. J Nucl Med. 2023;64(3):395-401. 24. Kroenke M, Mirzoyan L, Horn T, et al. Matched-pair comparison of 68Ga-PSMA-11 and 18F-rhPSMA-7 PET/CT in patients with primary and biochemical recurrence of prostate cancer: frequency of non–tumor-related uptake and tumor positivity. J Nucl Med. 2021;62(8):1082-1088. 25. Hagens MJ, Oprea-Lager DE, Vis AN, et al. Reproducibility of PSMA PET/CT imaging for primary staging of treatment-naïve prostate cancer patients depends on the applied radiotracer: a retrospective study. J Nucl Med. 2022;63(10):1531-1536. 26. Uprimny C, Bayerschmidt S, Kroiss AS, et al. Impact of forced diuresis with furosemide and hydration on the halo artefact and intensity of tracer accumulation in the urinary bladder and kidneys on [68Ga]Ga-PSMA-11-PET/CT in the evaluation of prostate cancer patients. Eur J Nucl Med Mol Imaging. 2021;48(1):123-133. 27. Data on File. Isotope Decay Rates. Telix Pharmaceuticals. 2022.