Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [68Ga]Ga-PSMA-11, Ga-PSMA-11, 68Ga-PSMA-11, AAA517
Gallium Ga 68 Gozetotide · 1 trial · 1 indication
Number/extent of lesions with at least a moderate update of any of the RLIs according to visual assessment scoring scale on each corresponding targeted PET/CT scan based on blinded independent central review (BICR) assessment.
Percentage changes in quantitative PET/CT parameters (SUVmax, SUVmean, SUVpeak, target-positive Tumor Volume (target -TV), Total Lesion (target (TL-target)\] and changes in number of target-positive lesions (as per visual assessment) on each corresponding target PET/CT based on BICR.
| Arm | Type | Description |
|---|---|---|
| PSMA-predominant Neuroendocrine prostate cancer (NEPC) | EXPERIMENTAL | - |
| Somatostatin Receptor 2 (SSTR2)-predominant NEPC | EXPERIMENTAL | - |
| Gastrin Releasing Peptide Receptor (GRPR)-predominant NEPC | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| [68Ga]Ga-PSMA-11 | DRUG | \[68Ga\]Ga-PSMA-11 will be administered as a single intravenous dose of approximately 150 MBq (4 mCi) to be administered during baseline imaging and at any time ≥ 6 weeks after first RLT dose. Sites should consider doing PET/CT imaging with RLT corresponding RLI as the first of three PET/CT scans. Administered dose should not be lower than 111 MBq (3 mCi) or higher than 259 MBq (7 mCi) |
| [68Ga]GA-DOTA-TATE | DRUG | \[68Ga\]Ga-DOTA-TATE will be administered as a single intravenous dose to be administered during baseline imaging and at any time ≥ 6 weeks after first RLT dose. Sites should consider doing PET/CT imaging with RLT corresponding RLI as the first of three PET/CT scans. within a range of 100-200MBq (2.7-5.4 mCi) |
| [68Ga]Ga-NeoB | DRUG | \[68Ga\]Ga-NeoB will be administered as a single intravenous dose to be administered during baseline imaging and at any time ≥ 6 weeks after first RLT dose. Sites should consider doing PET/CT imaging with RLT corresponding RLI as the first of three PET/CT scans. within a range of 150-250 MBq (4.1-6.8 mCi). |
| [177Lu]Lu-PSMA-617 | DRUG | \[177Lu\]Lu-PSMA-617 will be administered as an intravenous infusion at a dose of 7.4 GBq (200mCi) (+/- 10%), every 6 weeks for 6 cycles. |
| [177Lu]Lu-DOTA-TATE | DRUG | \[177Lu\]Lu-DOTA-TATE will be administered as an intravenous infusion at a dose of 7.4 GBq (200mCi) (+/- 10%) every 6 weeks for 6 cycles. |
| [177Lu]Lu-NeoB | DRUG | \[177Lu\]Lu-NeoB will be administered as an intravenous infusion at a dose of 9.25 GBq (250mCi) every 6 weeks for 6 cycles |
| L-Lysine HCl-L-Arginine HCl, 2.5 %, | DRUG | sterile solution for infusion Lysine HCl-Arginine HCl, 2.5 % (1L) |
| Gonadotropin-releasing hormone (GnRH) analogues | DRUG | Anatomical Therapeutic Chemical \[ATC\] code L02AE |
| GnRH antagonists | DRUG | abarelix, degarelix, or relugolix |
| Antiemetics & antinauseants | DRUG | ATC code A04A |
| Metoclopramide | DRUG | ATC code A03FA01 |
Key Inclusion criteria: * Participants must have metastatic prostate cancer with neuroendocrine differentiation as determined by at least one of the following: * Histologically small cell or neuroendocrine cancer from a primary prostate or metastatic biopsy confirmed by local laboratory. * Exp...
Gallium Ga 68 Gozetotide is being studied in metastatic neuroendocrine prostate cancer. It is an imaging agent directed at PSMA, a protein found on prostate cancer cells, and is being evaluated in an exploratory Phase 1 study that combines PSMA, SSTR2 and GRPR targeted radioligand therapy in this patient population.
Gallium Ga 68 Gozetotide targets PSMA, or prostate-specific membrane antigen, which serves as a biomarker in prostate cancer. By binding to PSMA, the gallium-68 labeled agent allows visualization of PSMA-expressing disease. In this program it is being studied in metastatic neuroendocrine prostate cancer, a setting where PSMA expression can guide radioligand therapy selection.
Novartis AG, which trades under the ticker NVS, is the developer of Gallium Ga 68 Gozetotide. The company is sponsoring the clinical program evaluating this PSMA-targeted agent in metastatic neuroendocrine prostate cancer.
Gallium Ga 68 Gozetotide is in Phase 1 development. It is an investigational agent and has not been approved for the metastatic neuroendocrine prostate cancer indication described here. The single Phase 1 study is currently active and not recruiting, with 31 participants planned.
Gallium Ga 68 Gozetotide is being studied in the NEPC Study, registered as NCT06379217, titled an exploratory safety and efficacy study with PSMA, SSTR2 and GRPR targeted radioligand therapy in metastatic neuroendocrine prostate cancer. The Phase 1 trial is active and not recruiting, enrolls 31 male participants aged 18 and older, and runs in the United States, France, Germany, Spain and the United Kingdom.
Yes. Gallium Ga 68 Gozetotide is also known as [68Ga]Ga-PSMA-11, Ga-PSMA-11, 68Ga-PSMA-11 and AAA517. These names refer to the same PSMA-targeted gallium-68 imaging agent developed by Novartis AG under ticker NVS.