Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [68Ga]Ga-PSMA-11
Ga-PSMA-11 · 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...
Ga-PSMA-11 is an investigational small molecule being studied for use in metastatic neuroendocrine prostate cancer. It is a PSMA-targeted radioligand therapy currently in Phase 1 clinical development. The drug is being evaluated in an exploratory safety and efficacy study for this condition.
Ga-PSMA-11 targets PSMA, a protein that is expressed on prostate cancer cells. By binding to PSMA, the drug is designed to deliver radiation therapy directly to cancer cells. This targeted approach is being investigated for the treatment of metastatic neuroendocrine prostate cancer.
Ga-PSMA-11 is being developed by Novartis AG, a global healthcare company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in metastatic neuroendocrine prostate cancer.
Ga-PSMA-11 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The current trial is an exploratory safety and efficacy study in patients with metastatic neuroendocrine prostate cancer.
Ga-PSMA-11 is being studied in a Phase 1 clinical trial with the identifier NCT06379217. This trial is titled 'NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.' The study is active but not recruiting, with an enrollment of 31 patients.
Yes, Ga-PSMA-11 is also known as [68Ga]Ga-PSMA-11. Both names refer to the same investigational drug being developed by Novartis AG for the treatment of metastatic neuroendocrine prostate cancer. The drug is a PSMA-targeted radioligand therapy currently in Phase 1 clinical trials.