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68Ga-PSMA-11
68Ga-PSMA-11 is a positron emission tomography (PET) imaging agent that binds to prostate-specific membrane antigen (PSMA) on prostate cancer cells to enable visualization and detection.
68Ga-PSMA-11 is a positron emission tomography (PET) imaging agent that binds to prostate-specific membrane antigen (PSMA) on prostate cancer cells to enable visualization and detection. Used for PET imaging of PSMA-positive lesions in prostate cancer patients for staging and restaging.
At a glance
| Generic name | 68Ga-PSMA-11 |
|---|---|
| Also known as | 68Ga-PSMA-HBED-CC, 68Ga-PSMA-11 injection, Illucix, gallium Ga 68 Gozetotide, 68-gallium prostate-specific membrane antigen 11 positron emission tomography/magnetic resonance imaging |
| Sponsor | Weill Medical College of Cornell University |
| Drug class | PET imaging agent / radiopharmaceutical |
| Target | PSMA (prostate-specific membrane antigen) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
68Ga-PSMA-11 consists of gallium-68 (a positron-emitting radioisotope) conjugated to a small molecule ligand that targets PSMA, a transmembrane protein highly expressed on prostate cancer cells. When injected intravenously, the agent accumulates at sites of PSMA expression, allowing PET imaging to detect and localize prostate cancer lesions, including metastases. This enables improved staging, restaging, and treatment planning in prostate cancer patients.
Approved indications
- PET imaging of PSMA-positive lesions in prostate cancer patients for staging and restaging
Common side effects
Key clinical trials
- 177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer (PHASE3)
- A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxane Treatment Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer (PHASE2)
- Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer in Japan (PHASE2)
- Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial (PHASE2)
- 68Ga-PSMA PET in the Renal Cell Carcinoma (NA)
- NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer. (PHASE1)
- An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) (PHASE3)
- Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT) (PHASE2)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |