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...