Generic drug: Gallium Ga 68 PSMA-11
Brand name: Gallium Ga 68 PSMA-11
What is Gallium Ga 68 PSMA-11 Injection, and how does it work?
Gallium Ga 68 PSMA-11 Injection is a radioactive diagnostic agent 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 or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
What are the side effects of Gallium Ga 68 PSMA-11?
Side effects of Gallium Ga 68 PSMA-11 include:
What is the dosage for Gallium Ga 68 PSMA-11?
- Handle Ga 68 PSMA-11 Injection with appropriate safety measures to minimize radiation exposure. Use waterproof gloves, effective radiation shielding, and other appropriate safety measures when preparing and handling Ga 68 PSMA-11 Injection.
- Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.
Recommended Dosage And Administration Instructions
In adults, the recommended amount of radioactivity to be administered for PET is 111 MBq to 259 MBq (3 mCi to 7 mCi) administered as an intravenous bolus injection.
- Use aseptic technique and radiation shielding when withdrawing and administering Ga 68 PSMA11 Injection.
- Calculate the necessary volume to administer based on calibration time and required dose.
- Inspect Ga 68 PSMA-11 Injection visually for particulate matter and discoloration before administration. Do not use the drug if the solution contains particulate matter or is discolored.
- Ga 68 PSMA-11 Injection may be diluted with sterile 0.9% Sodium Chloride Injection, USP.
- Assay the final dose immediately before administration to the patient in a dose calibrator.
- After injection of Ga 68 PSMA-11 Injection, administer an intravenous flush of sterile 0.9% Sodium Chloride Injection, USP to ensure full delivery of the dose.
- Dispose of any unused drug in a safe manner in compliance with applicable regulations.
- Unless contraindicated, a diuretic expected to act within the uptake time period may be administered at the time of radiotracer injection to potentially decrease artifact from radiotracer accumulation in the urinary bladder and ureters.
Patient Preparation Prior To PET Imaging
- Instruct patients to drink a sufficient amount of water to ensure adequate hydration prior to administration of Ga 68 PSMA-11 Injection and to continue to drink and void frequently following administration to reduce radiation exposure, particularly during the first hour after administration.
- Position the patient supine with arms above the head. Begin PET scanning 50 to 100 minutes after the intravenous administration of Ga 68 PSMA-11 Injection.
- Patients should void immediately prior to image acquisition and that image acquisition should begin at the proximal thighs and proceed cranially to the skull base or skull vertex.
- Adapt imaging technique according to the equipment used and patient characteristics in order to obtain the best image quality possible.
- Ga 68 PSMA-11 binds to prostate-specific membrane antigen (PSMA). Based on the intensity of the signals, PET images obtained using Ga 68 PSMA-11 Injection indicate the presence of PSMA in tissues.
- Lesions should be considered suspicious if uptake is greater than physiologic uptake in that tissue or greater than adjacent background if no physiologic uptake is expected.
- Tumors that do not bear PSMA will not be visualized. Increased uptake in tumors is not specific for prostate cancer.
- Estimated radiation absorbed doses per injected activity for organs and tissues of adult male patients following an intravenous bolus of Ga 68 PSMA-11 Injection are shown in Table 1.
- The effective radiation dose resulting from the administration of 259 MBq (7 mCi) is about 4.4 mSv. The radiation doses for this administered dose to the critical organs, which are the kidneys, urinary bladder, and spleen, are 96.2 mGy, 25.4 mGy, and 16.8 mGy, respectively.
- These radiation doses are for Ga 68 PSMA-11 Injection alone. If CT or a transmission source are used for attenuation correction, the radiation dose will increase by an amount that varies by technique.
Table 1: Estimated Radiation Absorbed Dose per Injected Activity in Selected Organs and Tissues of Adults after Intravenous Administration of Ga 68 PSMA-11 Injection
|Organ||Absorbed dose (mGy/MBq)|
|Effective Dose (mSv/MBq)||0.0169||0.0015|
What drugs interact with Gallium Ga 68 PSMA-11?
Androgen Deprivation Therapy And Other Therapies Targeting The Androgen Pathway
Is Gallium Ga 68 PSMA-11 safe to use while pregnant or breastfeeding?
- Ga 68 PSMA-11 Injection is not indicated for use in females.
- There are no available data with Ga 68 PSMA-11 Injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
- Ga 68 PSMA-11 Injection is not indicated for use in females.
- There are no data on the presence of Ga 68 PSMA-11 in human milk, the effect on the breastfed infant, or the effect on milk production.
Gallium Ga 68 PSMA-11 Injection is a radioactive diagnostic agent 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 or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Side effects of Gallium Ga 68 PSMA-11 include nausea, diarrhea, and dizziness.
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Prostate Cancer Staging and Survival Rates
The prognosis for prostate cancer, as with any cancer, depends on how advanced the cancer has become, according to established stage designations. The patient's PSA score at diagnosis, as well as their Gleason score (the grading system used to determine the aggressiveness of prostate cancer) determines the prognosis and final stage designation. Prostate cancer has a high survival rate in general, but your chances depend on the stage of the cancer.
What Are the 5 Warning Signs of Prostate Cancer?
Prostate cancer rarely produces symptoms in the early stage; however, few signs can help in detecting prostate cancer.
Prostate cancer is the most common cancer in men after skin cancer. Risk factors include age, family history, ethnicity, and diet. Prostate cancer is diagnosed by a digital rectal exam, prostate-specific antigen (PSA) test, and prostate biopsy. Symptoms may include frequent need to urinate, incontinence, pain, blood in the urine, fatigue, and more. Prognosis and treatment depend on cancer staging. Watchful waiting, surgery, radiation, cryotherapy, and other management strategies are available. Research and clinical trials strive to find new and better treatments for prostate cancer.
Prostate Cancer Treatment: Focal Therapy and Other Experimental Treatments
Several new and experimental treatments for prostate cancer are under study, including treatments that use ultrasound, lasers, tissue-freezing gas, and new ways of administering radiation. These new methods are types of focal therapy, that is, treatment focused on the cancer cells in the prostate, rather than systemic therapy that administers medications or other treatments to the whole body with the aim of treating the prostate.
Can Prostate Cancer Be Completely Cured?
Prostate cancer is the second most common cancer in men. Due to routine screening of prostate-specific antigen (PSA) levels in the United States, nearly 90% of prostate cancers get detected in early stages. When found early, there are several treatment options available and prostate cancer has a high chance of getting cured.
Prostate Cancer Early Signs and Symptoms
Difficulty with urination – frequency, weak stream, trouble getting started, etc. – is usually the first sign of prostate cancer. But these and other early symptoms of prostatic cancer can also come from benign prostate conditions, so diagnostic testing is important, including PSA tests and digital rectal exam.
Prostate Cancer Facts
Prostate cancer is a leading cause of cancer and cancer death in males; in some men, identifying it early may prevent or delay metastasis and death from prostate cancer. The prostate is a walnut-shaped gland that is a part of the male reproductive system that wraps around the male urethra at it exits the bladder. Prostate cancer is common in men over 50 years of age, with the risk of developing prostate cancer increases with aging.
How Is Prostate Cancer Diagnosed?
Prostate cancer is largely a disease of men over 40, so it’s around this age doctors recommend the first prostate screening. The first exam is a blood test to determine if there are abnormal prostate specific antigen (PSA) levels in your blood – PSA is produced by the prostate. If the PSA is high, your doctor will perform a digital rectal exam, during which the doctor feels your prostate from inside your rectum with a gloved finger. Other diagnostic tests include an endoscopic biopsy of tumor tissue for analysis in a lab.
Early-Stage Prostate Cancer Treatment
If prostate cancer is detected early and appears to be slow-growing, invasive procedures, chemotherapy, radiation and other approaches can sometimes do more harm than good. Many prostate cancer treatments come with side effects, like incontinence or impotence, so it’s in the patient’s interest to put off invasive treatments as long as is medically safe. Active surveillance is where doctors "watch and wait" for changes that could prompt medical intervention.
Prostate Cancer Treatment: Chemotherapy, Bone-Targeted and Immune Therapy
Doctors may introduce chemotherapy and immune therapy if other measures fail to cure a case of prostate cancer. However, unlike with other forms of cancer, chemotherapy isn’t the first choice for early prostate cancer. Immune therapy uses the body's own immune system to attack the prostate tumor, while bone-targeted therapy aims to preserve bone and prevent metastasis.
Prostate Cancer: Radical Prostatectomy Surgery
Radical prostatectomy, or surgical removal of the entire prostate gland, isn’t typically the first choice in prostate cancer treatment. Sometimes a radical approach is necessary to keep the cancer from metastasizing, however. Some cases are too severe or diagnosed too late for drugs or radiation to have much effect. In these cases, treatment teams may opt for a radical prostatectomy, despite potential side effects like impotence and incontinence.
Prostate Cancer: Radiation, Brachytherapy and Radiopharmaceuticals
Radiation treatment for prostate cancer is a powerful tool at doctors’ disposal. Using radiation vs. surgery or other invasive treatments to kill cancer cells may still cause side effects, but ideally they are less severe. Radiation therapy can be performed via external beam therapy (EBRT) or the placement of radioactive seeds into the prostate (prostate brachytherapy) or using radioactive drugs (radiopharmaceuticals).
Prostate Cancer Treatment: Hormonal Therapy
Prostate cancer is highly sensitive to, and dependent on, the level of the male hormone testosterone, which drives the growth of prostate cancer cells. Testosterone belongs to a family of hormones called androgens, and today front-line hormonal therapy for advanced and metastatic prostate cancer is called androgen deprivation therapy (ADT).
What Is the Latest Treatment for Prostate Cancer?
Prostate cancer affects 1 in 5 men. Learn how it is diagnosed and treated by doctors.
When Should You Screen for Prostate Cancer?
Screening for prostate cancer helps detecta tumor early, enabling timely treatment and prevention of any complications. According to the American Cancer Society (ACS), the decision to get screened should be made by men in consultation with their doctor. The doctor needs to counsel the men about the uncertainties involved in the screening process, the risks and potential benefits of getting screened for prostate cancer.
The Early Signs of Prostate Cancer
Prostate cancer in its early stages usually causes no signs and symptoms. Screening can help detect the cancer early.
How Is Prostate Cancer Screening Done?
There are no standard or routine screening tests for prostate cancer. Studies are being done to find ways to make prostate-specific antigen (PSA) testing more accurate for early cancer detection.
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