Illuccix (Gallium Ga 68 Gozetotide)

Radiopharmaceutical diagnostic agent for PSMA PET imaging in prostate cancer

Prescription Only (Rx) ATC: V09IX Radiopharmaceutical
Active Ingredient
Gallium Ga 68 gozetotide
Dosage Form
Injection, solution (IV)
Manufacturer
Telix Pharmaceuticals
FDA Approved
December 2021
Reviewed by iMedic Medical Board
Published:
Updated:
Evidence Level 1A

Illuccix (gallium Ga 68 gozetotide) is a radioactive diagnostic agent used with positron emission tomography (PET) imaging to detect prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer. It is the first commercially available PSMA-targeted PET imaging agent approved by the FDA for detecting suspected metastatic prostate cancer and suspected recurrence of prostate cancer. Illuccix is administered by intravenous injection in a licensed nuclear medicine facility and provides highly sensitive imaging that can detect disease earlier than conventional imaging methods.

Quick Facts

Active Ingredient
Ga-68 Gozetotide
Drug Class
Radiopharmaceutical
ATC Code
V09IX
Common Use
PSMA PET Imaging
Dosage Form
IV Injection
Prescription Status
Rx Only

Key Takeaways

  • Illuccix is the first FDA-approved gallium-68 labeled PSMA-targeted PET imaging agent for prostate cancer, providing superior detection compared to conventional imaging.
  • It is indicated for patients with suspected metastatic prostate cancer eligible for initial definitive therapy, and for patients with suspected recurrence based on rising PSA levels.
  • The drug is administered as a single intravenous injection (111-259 MBq) in a nuclear medicine facility, with PET imaging performed 50-100 minutes afterward.
  • PSMA PET imaging with Illuccix has demonstrated detection rates of 40-75% in biochemical recurrence even at very low PSA levels, outperforming standard CT and bone scans.
  • The agent is generally well tolerated; common side effects are mild and include nausea, diarrhea, and dizziness. Radiation exposure is kept as low as reasonably achievable.

What Is Illuccix and What Is It Used For?

Quick Answer: Illuccix (gallium Ga 68 gozetotide) is a radiopharmaceutical diagnostic agent used for PET imaging to detect prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer. It helps identify both primary and metastatic disease with high sensitivity.

Illuccix is a radioactive diagnostic drug designed to help physicians visualize and locate prostate cancer cells throughout the body. It belongs to a class of medications known as radiopharmaceutical diagnostic agents, which are radioactive compounds used in medical imaging procedures. Specifically, Illuccix targets prostate-specific membrane antigen (PSMA), a protein that is significantly overexpressed on the surface of most prostate cancer cells.

The active ingredient in Illuccix is gallium Ga 68 gozetotide, a small molecule that binds with high affinity to PSMA. When injected intravenously, the compound circulates through the bloodstream and accumulates at sites where PSMA is present in high concentrations, essentially marking prostate cancer cells for detection. The gallium-68 radiolabel emits positrons that are detected by a PET scanner, creating detailed images that reveal the location and extent of prostate cancer.

Illuccix was approved by the United States Food and Drug Administration (FDA) in December 2021, making it the first commercially available gallium-68 labeled PSMA-targeted PET imaging agent. Previously, PSMA PET imaging was only available at a limited number of academic medical centers that could produce the radiotracer on-site. The commercial availability of Illuccix has dramatically expanded patient access to this advanced imaging technology.

Approved Indications

Illuccix is specifically indicated for two clinical scenarios in men with prostate cancer:

  • Suspected metastasis eligible for initial definitive therapy: In patients who have been diagnosed with prostate cancer and are candidates for curative treatment (such as surgery or radiation therapy), Illuccix PET imaging can detect whether the cancer has spread beyond the prostate gland. This information is critical for determining the most appropriate treatment strategy.
  • Suspected recurrence based on elevated PSA levels: In patients who have previously been treated for prostate cancer and show rising prostate-specific antigen (PSA) levels in their blood, Illuccix PET imaging can locate the site of disease recurrence. Identifying the location of recurrent cancer enables targeted salvage therapy, which may improve outcomes.

How PSMA PET Imaging Works

Prostate-specific membrane antigen (PSMA) is a transmembrane glycoprotein that is expressed at very low levels on normal prostate cells but is dramatically upregulated on prostate cancer cells. Expression levels of PSMA can be 100 to 1,000 times higher on cancer cells compared to normal prostate tissue. Furthermore, PSMA expression tends to increase with disease aggressiveness, in metastatic disease, and in castration-resistant prostate cancer, making it an ideal target for both diagnostic imaging and targeted therapy.

When Illuccix is injected, the gallium Ga 68 gozetotide molecule binds specifically to PSMA on cell surfaces. The gallium-68 isotope then undergoes radioactive decay, emitting positrons that travel a short distance before colliding with electrons. This collision produces two gamma rays that travel in opposite directions and are detected simultaneously by the PET scanner, allowing precise localization of the PSMA-expressing cells.

The resulting PET images provide a whole-body map of PSMA-positive sites, revealing not only the primary tumor but also metastases in lymph nodes, bones, and soft tissues. When combined with computed tomography (CT) in a PET/CT scan, both functional and anatomical information are obtained, providing comprehensive staging of the disease.

Clinical Significance

PSMA PET imaging with Illuccix has fundamentally changed the management of prostate cancer. Studies demonstrate that PSMA PET changes the treatment plan in approximately 50-70% of patients compared to conventional imaging alone. This includes upstaging patients who were thought to have localized disease and downstaging patients who were previously believed to have widespread metastases.

What Should You Know Before Receiving Illuccix?

Quick Answer: Before receiving Illuccix, inform your healthcare provider about all medications you are taking, particularly androgen deprivation therapy (ADT) or other hormonal treatments for prostate cancer, as these may affect PSMA expression and image interpretation. Pregnancy must be ruled out in female partners, as radiation can harm a developing fetus.

Before undergoing Illuccix PET imaging, several important considerations should be discussed with your healthcare team. Although Illuccix is a diagnostic agent rather than a therapeutic drug, proper preparation and awareness of potential limitations are essential for obtaining accurate and clinically meaningful results.

Contraindications

There are no absolute contraindications listed in the prescribing information for Illuccix. However, the following situations require careful consideration:

  • Known hypersensitivity: Patients with a known hypersensitivity to gallium Ga 68 gozetotide or any component of the formulation should not receive Illuccix.
  • Pregnancy: Illuccix can cause fetal harm when administered to a pregnant woman due to radiation exposure. While the primary patient population is male prostate cancer patients, female healthcare workers and partners should be aware of radiation safety precautions.

Warnings and Precautions

Several important warnings and precautions are associated with Illuccix use:

Risk of image misinterpretation: PSMA PET imaging with Illuccix can produce both false-positive and false-negative results. PSMA is not exclusively expressed on prostate cancer cells; it can also be found on other tissues including the salivary glands, kidneys, small intestine, liver, and spleen, as well as in some non-prostate cancers. Additionally, some prostate cancer lesions may have low or absent PSMA expression, leading to false-negative results. Image interpretation should always be performed by qualified nuclear medicine physicians and should be correlated with the patient's clinical history, pathology, and other diagnostic findings.

Radiation exposure: Illuccix contributes to the patient's overall long-term cumulative radiation exposure. Radiation exposure is associated with a dose-dependent risk of cancer development. Healthcare providers should ensure that the lowest effective dose is administered, and patients should be advised to hydrate well and void frequently after the procedure to reduce radiation exposure to the bladder.

Impact of androgen deprivation therapy (ADT): Androgen deprivation therapy and other hormonal treatments for prostate cancer can affect PSMA expression levels on cancer cells. Some studies have shown that short-term ADT can transiently increase PSMA expression, while prolonged therapy may have variable effects. The timing of PSMA PET imaging relative to hormonal treatment initiation or changes should be carefully considered and discussed with the treating physician.

Pregnancy and Breastfeeding

Illuccix is classified as a radioactive drug and can cause fetal harm. Although the primary patient population consists of men with prostate cancer, the following considerations apply:

  • Female healthcare workers who are pregnant or may be pregnant should follow radiation safety protocols when handling or being near patients who have received Illuccix.
  • Male patients who have female partners of reproductive potential should use effective contraception during and for a period after the imaging procedure, as recommended by their physician.
  • Breastfeeding considerations are generally not applicable to the primary patient population but should be discussed with a healthcare provider if relevant.
Important Radiation Safety Warning

After receiving Illuccix, you will emit low levels of radiation for several hours. Follow all instructions from the nuclear medicine staff regarding contact with others, especially pregnant women and young children. Drink plenty of fluids and urinate frequently to help eliminate the radioactive material from your body more quickly.

How Does Illuccix Interact with Other Drugs?

Quick Answer: The most clinically significant interactions with Illuccix involve androgen-pathway directed therapies that can alter PSMA expression on cancer cells, potentially affecting imaging accuracy. No formal drug-drug interaction studies have been conducted, but certain medications may influence image interpretation.

Unlike traditional therapeutic medications, Illuccix is a single-dose diagnostic agent that does not undergo significant hepatic metabolism or renal drug interactions in the traditional pharmacokinetic sense. However, several classes of medications can influence the accuracy and interpretation of PSMA PET imaging results by altering PSMA expression on prostate cancer cells or affecting the biodistribution of the tracer.

Major Interactions

Androgen receptor-targeted therapies represent the most clinically relevant interactions with PSMA PET imaging. These medications can modulate PSMA expression on prostate cancer cells, potentially leading to changes in tracer uptake that may affect image interpretation:

Major Drug Interactions with Illuccix
Drug/Class Effect on PSMA Imaging Clinical Recommendation
Enzalutamide May transiently increase PSMA expression initially, then decrease with prolonged use Discuss timing of scan with treating oncologist
Abiraterone Can alter PSMA expression; effect varies by duration of therapy Consider scan timing relative to treatment initiation
GnRH Agonists/Antagonists (e.g., leuprolide, degarelix) ADT may affect PSMA expression levels; short-term treatment may increase expression Inform nuclear medicine physician of ADT status and duration
Darolutamide Androgen receptor inhibitor that may modulate PSMA expression Document current treatment in imaging request

Minor Interactions

Several other medications and substances may have minor effects on PSMA PET imaging quality or interpretation, though these are generally less clinically significant:

Minor Drug Interactions with Illuccix
Drug/Class Potential Effect Clinical Recommendation
Diuretics May affect hydration status and renal clearance of tracer Ensure adequate hydration; discuss with imaging team
5-Alpha Reductase Inhibitors (finasteride, dutasteride) Minimal effect on PSMA expression in most studies No dose modification required; document use
Corticosteroids High-dose steroids may theoretically affect PSMA expression Inform imaging team of current steroid use
Important Note on Drug Interactions

No formal drug-drug interaction studies have been conducted with Illuccix. The interactions listed above are based on the known pharmacology of PSMA and the mechanism of action of these medications. Always provide a complete medication list to the nuclear medicine team before your PSMA PET scan to ensure accurate image interpretation.

What Is the Correct Dosage of Illuccix?

Quick Answer: The recommended dose of Illuccix is 111 to 259 MBq (3 to 7 mCi) administered as a single intravenous injection. PET imaging is initiated approximately 50 to 100 minutes after injection. The drug is always prepared and administered by trained nuclear medicine professionals.

Illuccix is not a medication that patients self-administer. It is always prepared and administered by qualified nuclear medicine professionals in a licensed imaging facility. The dosage is measured in megabecquerels (MBq) or millicuries (mCi), which are units of radioactivity, rather than in milligrams as with conventional medications.

Adults

Recommended Adult Dose

Dose: 111 to 259 MBq (3 to 7 mCi) as a single intravenous bolus injection

Volume: Total volume of injection not to exceed 10 mL

Imaging timing: PET imaging should begin approximately 50 to 100 minutes after injection

Image acquisition: Whole-body PET/CT scan from vertex of skull to mid-thigh (or to feet if clinically indicated)

The exact dose within the recommended range is determined by the nuclear medicine physician based on patient factors including body weight, the type of PET scanner being used, and institutional protocols. The goal is to achieve optimal image quality while keeping radiation exposure as low as reasonably achievable (the ALARA principle).

Children

Pediatric Dosage

Illuccix is not indicated for use in pediatric patients. The safety and effectiveness of Illuccix in pediatric patients have not been established. Prostate cancer is exceedingly rare in children and adolescents.

Elderly

Geriatric Dosage

No specific dose adjustment is required for elderly patients. Clinical studies of Illuccix included patients up to 90 years of age, and the dosing is the same as for younger adults. However, elderly patients should be monitored for adequate hydration before and after the procedure, particularly if they have renal impairment or are taking diuretics.

Preparation Before the Scan

Patients undergoing Illuccix PET imaging should follow these preparation guidelines:

  • Hydration: Drink plenty of water before and after the injection to promote urinary excretion of the radiotracer and reduce radiation dose to the bladder.
  • Voiding: Empty the bladder immediately before image acquisition and frequently after the procedure.
  • Fasting: No specific fasting requirements for PSMA PET imaging (unlike FDG PET, which requires fasting).
  • Medications: Continue all regular medications unless specifically instructed otherwise by the ordering physician.

Missed Dose

The concept of a missed dose does not apply to Illuccix in the traditional sense, as it is a single-dose diagnostic agent administered at a scheduled imaging appointment. If a patient is unable to attend their scheduled PSMA PET scan, a new appointment should be arranged. Because gallium-68 has a short half-life of approximately 68 minutes, each dose of Illuccix must be freshly prepared shortly before administration. A missed appointment may require rescheduling depending on the availability of the gallium-68 generator and institutional scheduling.

Overdose

In the event of an inadvertent overdose of Illuccix, the primary concern is increased radiation exposure. There is no specific antidote for radiation overdose from gallium-68. Management of overdose includes:

  • Encouraging aggressive hydration and frequent urination to accelerate elimination of the radiotracer
  • Monitoring the patient for any adverse effects
  • Calculating the estimated radiation dose received and consulting radiation safety experts if the dose significantly exceeds the intended range
  • Documentation of the event according to institutional radiation safety protocols

What Are the Side Effects of Illuccix?

Quick Answer: Illuccix is generally well tolerated. The most commonly reported side effects include nausea, diarrhea, and dizziness, which are typically mild and transient. Serious adverse reactions are rare. The primary safety consideration is radiation exposure, which is managed by using the lowest effective dose and encouraging hydration.

Clinical trials of Illuccix demonstrated a favorable safety profile, consistent with other gallium-68 labeled PET tracers. In the pivotal clinical studies that led to FDA approval, the incidence of adverse events was low, and most reported side effects were mild in severity and resolved without intervention.

The CONDOR trial (a multicenter study of 208 patients with biochemically recurrent prostate cancer) and the OSPREY trial (a prospective study in patients with high-risk prostate cancer or biochemical recurrence) provided the primary safety data for Illuccix. Across these studies, the overall incidence of drug-related adverse events was approximately 3-5%.

Common Side Effects

Affects 1-10 in 100 patients (1-10%)

  • Nausea
  • Diarrhea
  • Dizziness

Uncommon Side Effects

Affects 1-10 in 1,000 patients (0.1-1%)

  • Headache
  • Fatigue
  • Injection site reactions (pain, redness, swelling)
  • Altered taste (dysgeusia)
  • Flushing

Rare Side Effects

Affects fewer than 1 in 1,000 patients (<0.1%)

  • Hypersensitivity reactions
  • Erythema (skin redness)
  • Abdominal discomfort
  • Chills

Radiation-Related Considerations

As with all radiopharmaceuticals, Illuccix exposes patients to ionizing radiation. The effective dose from a typical Illuccix injection is estimated at approximately 4-5 millisieverts (mSv) for the radiopharmaceutical component alone. When combined with the CT component of a PET/CT scan, the total effective dose is typically in the range of 10-15 mSv, which is comparable to other nuclear medicine procedures and within accepted limits for diagnostic imaging.

The organs receiving the highest radiation dose from Illuccix include the kidneys, bladder wall, and salivary glands, as these tissues have naturally high PSMA expression. Adequate hydration and frequent voiding after the procedure help reduce the radiation dose to the bladder.

The long-term risk of radiation-induced cancer from a single diagnostic dose of Illuccix is considered very low, and the clinical benefit of accurate cancer staging and treatment planning generally far outweighs this minimal risk. However, radiation exposure should always be minimized, and the necessity of each imaging procedure should be carefully evaluated.

When to Seek Medical Attention

Although serious adverse reactions to Illuccix are rare, patients should contact their healthcare provider if they experience any of the following after the procedure:

  • Signs of an allergic reaction such as rash, hives, difficulty breathing, or swelling of the face, lips, or throat
  • Persistent nausea or vomiting lasting more than 24 hours
  • Severe dizziness or fainting
  • Any unexpected or concerning symptoms in the days following the scan

How Should Illuccix Be Stored?

Quick Answer: Illuccix is stored and handled exclusively by nuclear medicine facilities. Patients do not need to store this medication at home. It must be used within 3 hours of preparation due to the short half-life of gallium-68 (approximately 68 minutes).

Illuccix is a radioactive medication that requires specialized handling, storage, and disposal procedures. Patients never handle or store Illuccix themselves; it is managed entirely by trained nuclear medicine professionals in appropriately licensed facilities.

The key storage and handling requirements for Illuccix include:

  • Temperature: Store at controlled room temperature, 20-25 degrees Celsius (68-77 degrees Fahrenheit), with excursions permitted to 15-30 degrees Celsius (59-86 degrees Fahrenheit).
  • Radiation shielding: Must be stored in appropriate radiation-shielded containers (lead-lined vial shields) in designated radioactive material storage areas.
  • Time constraints: Due to the short half-life of gallium-68 (approximately 68 minutes), the prepared injection must be used within 3 hours of the end of synthesis. After this time, the radioactivity has decayed to a level that may be insufficient for adequate image quality.
  • Quality control: Each prepared dose must pass quality control testing before patient administration, verifying radiochemical purity, radioactivity concentration, and pH.
  • Disposal: Any unused Illuccix must be disposed of according to federal, state, and local regulations for radioactive waste.

The Illuccix kit, before reconstitution with the gallium-68 eluate, should be stored at 25 degrees Celsius (77 degrees Fahrenheit) or below. The kit should not be used past its expiration date. Proper cold chain and storage conditions are maintained by the supplying radiopharmacy or nuclear medicine department.

What Does Illuccix Contain?

Quick Answer: Illuccix contains gallium Ga 68 gozetotide as the active ingredient. The kit includes the gozetotide precursor, buffer solutions, and reaction components that are combined with gallium-68 from a germanium-68/gallium-68 generator to produce the final injectable product.

Illuccix is supplied as a sterile, non-pyrogenic single-dose kit for the preparation of gallium Ga 68 gozetotide injection. The preparation involves combining the kit components with gallium-68 eluted from a germanium-68/gallium-68 (Ge-68/Ga-68) generator. Understanding the composition of Illuccix helps patients and healthcare providers appreciate the nature of this diagnostic agent.

Active Ingredient

The active pharmaceutical ingredient is gallium Ga 68 gozetotide, also known as 68Ga-PSMA-11 or 68Ga-HBED-CC-PSMA. Gozetotide is a small-molecule ligand that binds specifically to the enzymatic active site of prostate-specific membrane antigen (PSMA). When radiolabeled with gallium-68, it serves as a PET radiotracer that localizes to PSMA-expressing tissues.

Gallium-68 is a positron-emitting radionuclide with a physical half-life of 67.71 minutes. It decays primarily by positron emission (89%) and electron capture (11%) to stable zinc-68. The principal photon useful for PET imaging is the 511 keV annihilation radiation produced when a positron encounters an electron.

Kit Components

The Illuccix kit contains the following components, which are combined during preparation:

  • Gozetotide precursor vial: Contains the PSMA-targeting ligand (HBED-CC-PSMA) in lyophilized form
  • Buffer solution: Sodium acetate buffer to maintain appropriate pH for the radiolabeling reaction
  • Reaction vial: A sterile vial in which the radiolabeling reaction occurs when gallium-68 eluate is added
  • Quality control components: Materials for testing the radiochemical purity and other quality parameters of the final product

The final prepared injection is a clear, colorless to slightly yellow solution with a pH between 3.2 and 5.5. It does not contain preservatives and is intended for single use only. Each prepared dose contains gallium Ga 68 gozetotide at the time of calibration, along with trace amounts of the buffer and reaction components.

About the Gallium-68 Generator

The gallium-68 used in Illuccix is produced from a germanium-68/gallium-68 generator. Germanium-68 has a half-life of approximately 271 days, allowing the generator to produce gallium-68 for up to one year. The gallium-68 is eluted (washed out) from the generator as needed and immediately used to radiolabel the gozetotide precursor in the Illuccix kit. This generator-based system eliminates the need for an on-site cyclotron, making PSMA PET imaging accessible to more facilities.

Frequently Asked Questions About Illuccix

Illuccix (gallium Ga 68 gozetotide) is used for positron emission tomography (PET) imaging to detect prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer. It is approved for two specific indications: detecting suspected metastatic disease in patients who are candidates for initial definitive therapy (such as surgery or radiation), and locating the site of disease recurrence in patients whose PSA levels are rising after previous treatment. Illuccix helps physicians determine the extent and location of prostate cancer with greater accuracy than conventional imaging methods like CT scans and bone scintigraphy.

The Illuccix PET scan is performed at a nuclear medicine or PET/CT imaging facility. After checking in, you will receive a single intravenous injection of Illuccix in your arm. You will then wait approximately 50 to 100 minutes while the tracer circulates through your body and binds to PSMA-positive cells. You will be asked to urinate before the scan to clear radioactivity from the bladder and improve image quality. During the scan, you lie still on a table that moves through the PET/CT scanner. The entire imaging process typically takes 20 to 30 minutes. Afterward, you can resume normal activities, though you should drink extra fluids and urinate frequently to help eliminate the radiotracer.

Illuccix is generally very well tolerated. In clinical trials, the most commonly reported side effects were nausea, diarrhea, and dizziness, all of which were typically mild and resolved quickly without treatment. Uncommon side effects include headache, fatigue, injection site reactions, and altered taste. Serious allergic reactions are extremely rare. The main safety consideration is radiation exposure, which is managed by using the lowest effective dose. The total radiation exposure from an Illuccix PET/CT scan is similar to other nuclear medicine procedures and is considered safe for diagnostic purposes.

PSMA PET imaging with Illuccix has been shown to be significantly more sensitive and specific than conventional imaging techniques for detecting prostate cancer. In the CONDOR trial, Illuccix correctly localized disease in 84% of patients with biochemical recurrence, compared to much lower detection rates with conventional CT and bone scans. Studies show that PSMA PET can detect recurrent disease at PSA levels as low as 0.2 ng/mL, where conventional imaging typically fails. PSMA PET changes the clinical management in approximately 50-70% of patients, often leading to more targeted and effective treatment approaches.

Illuccix was approved by the U.S. FDA in December 2021 and has since gained regulatory approval in several countries. In Europe, a similar gallium-68 PSMA-11 product has been used under institutional or compassionate use frameworks at various academic centers. Availability varies by country and region, as it depends on local regulatory approvals, the availability of germanium-68/gallium-68 generators, and the presence of qualified nuclear medicine facilities. Patients interested in PSMA PET imaging should consult with their urologist or oncologist to determine availability in their area. Telix Pharmaceuticals, the manufacturer, has been expanding global access progressively.

No, Illuccix is a diagnostic agent only and is not used for treatment. It helps detect and locate prostate cancer but does not treat it. However, the PSMA target that Illuccix binds to is also used in therapeutic applications. PSMA-targeted radioligand therapy (such as lutetium-177 PSMA-617, marketed as Pluvicto) uses a similar PSMA-binding molecule labeled with a therapeutic radioisotope to deliver radiation directly to cancer cells. The diagnostic PSMA PET scan with Illuccix can help identify patients who are likely to benefit from PSMA-targeted therapy by confirming that their cancer expresses PSMA.

Gallium-68, the radioactive component of Illuccix, has a physical half-life of approximately 68 minutes. This means that every 68 minutes, the amount of radioactivity in your body decreases by half. Within 6 to 8 hours (approximately 5-7 half-lives), the radioactivity has decayed to negligible levels. Additionally, the tracer is actively eliminated from the body through the kidneys and urinary system. By drinking plenty of fluids and urinating frequently after the scan, you can help accelerate this elimination. Most of the radiation exposure occurs within the first few hours after injection.

References

This article is based on the following peer-reviewed sources and official medical guidelines:

  1. U.S. Food and Drug Administration. Illuccix (gallium Ga 68 gozetotide) Prescribing Information. Approved December 2021. FDA Application Number: 214451.
  2. Fendler WP, Calais J, Eiber M, et al. Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer: A Prospective Single-Arm Clinical Trial. JAMA Oncology. 2019;5(6):856-863. doi:10.1001/jamaoncol.2019.0096
  3. Morris MJ, Rowe SP, Gorin MA, et al. Diagnostic Performance of 18F-DCFPyL-PET/CT in Men with Biochemically Recurrent Prostate Cancer: Results from the CONDOR Phase III, Multicenter Study. Clinical Cancer Research. 2021;27(13):3674-3682.
  4. Pienta KJ, Gorin MA, Rowe SP, et al. A Phase 2/3 Prospective Multicenter Study of the Diagnostic Accuracy of Prostate Specific Membrane Antigen PET/CT with 18F-DCFPyL in Prostate Cancer Patients (OSPREY). Journal of Urology. 2021;206(1):52-61.
  5. Hofman MS, Lawrentschuk N, Francis RJ, et al. Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multicentre study. The Lancet. 2020;395(10231):1208-1216. doi:10.1016/S0140-6736(20)30314-7
  6. Sartor O, de Bono J, Chi KN, et al. Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. New England Journal of Medicine. 2021;385(12):1091-1103. doi:10.1056/NEJMoa2107322
  7. European Association of Nuclear Medicine (EANM). Procedure Guideline for PET/CT Imaging of Prostate Cancer with 68Ga-PSMA-11. European Journal of Nuclear Medicine and Molecular Imaging. 2022;49:1174-1190.
  8. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer. Version 4.2025.
  9. World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd List, 2023.
  10. Perera M, Papa N, Roberts M, et al. Gallium-68 Prostate-specific Membrane Antigen Positron Emission Tomography in Advanced Prostate Cancer - Updated Diagnostic Utility, Sensitivity, Specificity, and Distribution of Prostate-specific Membrane Antigen-avid Lesions: A Systematic Review and Meta-analysis. European Urology. 2020;77(4):403-417.

Editorial Team

This article has been written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in nuclear medicine, oncology, and urology.

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Written by the iMedic Medical Content Team, specialists in pharmaceutical and oncology information. All content follows the GRADE evidence framework and international clinical guidelines.

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Reviewed by the iMedic Medical Review Board, an independent panel of board-certified physicians in nuclear medicine and oncology. Reviewed for medical accuracy, completeness, and adherence to FDA, EMA, and NCCN guidelines.

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