Benefits of PSMA PET
Benefits of PSMA PET
PSMA Imaging to improve patient management
The diagnosis and treatment of prostate cancer have significantly advanced in recent years.1 In particular, prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) has emerged as a key imaging technique for assessing prostate cancer.2 A growing body of research highlights PSMA PET/CT as a superior option for diagnosis and staging compared to traditional imaging methods, demonstrating enhanced sensitivity, specificity, and accuracy in detecting the disease.3 Initially, PSMA PET/CT was primarily used for advanced prostate cancer treatment; however, recent studies now support its use much earlier in the disease process, including prior to initial treatment selection and for follow-up after therapy. As clinical experience with PSMA PET/CT expands, it is becoming the preferred imaging choice for physicians, aiding in diagnosis and staging to inform treatment decisions.1
Radiopharmaceutical Clinical Equivalence
Current evidence does not indicate a significant clinical impact of different radioligands, and the published data has not sufficiently distinguished the radiotracers based on their clinical effectiveness.2 Understanding the physiological distribution and common pitfalls associated with each radiopharmaceutical is essential for accurate interpretation of PSMA PET/CT. Ultimately, the choice of tracer should be guided by factors such as access, availability, and the infrastructure of the imaging facility.
“After 10 years of clinical use and experience, the best PSMA radiotracer is actually the one you can access.”4
Michael Hofman, MBBS, FRACP, FAANMS, FICIS, GAICD
1. Hoffman A, Amiel GE. The Impact of PSMA PET/CT on Modern Prostate Cancer Management and Decision Making-The Urological Perspective. Cancers (Basel). 2023 Jun 29;15(13):3402. doi: 10.3390/cancers15133402.
2. S. Huang et al. Comparison of 18F-based PSMA radiotracers with Gallium-68 Gozetotide (PSMA-11) in PET/CT imaging of prostate cancer—a systematic review and meta-analysis. Prostate Cancer and Prostatic Diseases; 2023. https://doi.org/10.1038/s41391-023-00755-2
3. Hofman MS et al. Prostate-specific membrane antigen PET-CT before radical treatment. The Lancet, 2020 Apr 395;10231: 1170 – 1172.
4. Hofman MS. Comparing PSMA Ligands for Prostate Cancer Imaging. Urology Today 2024, May 31. https://www.urotoday.com/video-lectures/imaging-prostate-cancer/video/mediaitem/4068-comparing-psma-ligands-for-prostate-cancer-imaging-michael-hofman.html
Are you looking to expand PSMA in your practice?
Gallium-68 Gozetotide (PSMA-11) Partnership opportunities are available now
Prostate PSMA imaging is quickly evolving to meet a long-standing need in diagnostic oncology. The emergence of PSMA PET radiopharmaceuticals is the key to this development. IONETIX is establishing FDA approved manufacturing of PSMA radiopharmaceuticals in select markets leading to enhancing supply, increasing flexibility, and creating partnership opportunities. Partnering with IONETIX allows for a customized supply to meet specific practice and provider needs with flexibility in volumes and timing. We are interested in collaborating with local professionals committed to providing this exceptional imaging modality to their patients and exploring various partnership opportunities to optimize PSMA PET imaging together.
CONTACT US
To learn more about PSMA imaging with Gallium Ga 68 Gozetotide, contact clinical@ionetix.com.
Indications and Usage
Gallium Ga 68 gozeotide injection is indicated 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.
WARNINGS AND PRECAUTIONS
Risk for Misdiagnosis
Image interpretation errors can occur with gallium Ga 68 gozetotide 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. The performance of Gallium Ga 68 gozetotide injection for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of Gallium Ga 68 gozetotide injection for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score. 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.
Radiation Risks
Gallium Ga 68 gozetotide injection 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 health care workers. Advise patients to hydrate before and after administration and to void frequently after administration.
ADVERSE REACTIONS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of Gallium Ga 68 gozetotide injection was evaluated in 960 patients, each receiving one dose of Gallium Ga 68 gozetotide injection. 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 a comprehensive list.
For full prescribing Information: https://dailymed.nlm.nih.gov/
dailymed/drugInfo.cfm?setid=357655a4-b3ee-4ea1-a1ea-50d4686546bb
Sites are encouraged to report any negative side effects of prescription drugs to the FDA. Visit: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program or call 1-800-FDA-1088
