Metastatic neuroendocrine prostate cancer Cancer
Conditions
Interventions
Prostate cancer is a malignant condition which develops in the prostate gland. When cancer has spread past the prostate into the body, it is called metastatic. Metastatic castration-resistant prostate
Sponsors
Novartis Pharmaceuticals UK Limited
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Participants must be adults =18 years of age. 2. Participants must have an ECOG performance status =1 3. Participants must have histological confirmation of adenocarcinoma of the prostate 4. Participants must be PSMA-positive per gallium (68Ga) gozetotide (also referred to as [68Ga]Ga-PSMA-11 or radiolabeled AAA517 and 68 Ga-PSMA-11) positron emission tomographic–computed tomographic (PET/CT) scans at baseline with at least 1 lesion showing intermediate or high uptake level (PSMA expression score 2 or 3 per PROMISE V2 criteria and no lesions meeting the size criteria as defined in the read rules showing PSMA expression scores 0 or 1 as determined by the central reader 5. Participants must have a castrate level of serum/plasma testosterone (=50 ng/dL or =1.7 nmol/L) either by pharmaceutical or surgical methods 6. Participants must have progressed only once on prior second generation ARPIs (abiraterone, enzalutamide, darolutamide, or apalutamide)
Exclusion criteria
Exclusion criteria: 1. Previous treatment with any of the following within 6 months of study enrollment: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. 2. Any previous radioligand therapy. 3. Prior treatment with cytotoxic chemotherapy for metastatic castration-resistant or metastatic hormone-sensitive prostate cancer (mHSPC) (e.g., taxanes, platinum, estramustine, vincristine, methotrexate, etc.), immunotherapy or biological therapy [including monoclonal antibodies]. [Note: Taxane exposure (maximum 6 cycles) in the adjuvant or neoadjuvant setting is allowed if 12 months have elapsed since completion of this adjuvant or neoadjuvant therapy. Prior treatment with sipuleucel-T is allowed]. 4. Any investigational agents within 42 days prior to the day of the first RLT treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Organ dosimetry of AAA617 measured using time activity curves (TACs) and absorbed radiation dose of AAA617 in organs. Absorbed radiation dose to target organs will be calculated by entering the TIAC values for all the source organs in the OLINDA/EXM® or other appropriate software program and adjusting the radiation dose reported by the software for individual weight and organ masses for organs of interest (determined from CT), and red marrow. For dosimetry assessments at Cycle 4, 6, 8, 10, 11, and 12, the individual TACs constructed from Cycle 1 may be scaled based on the organ activities extracted from one or both SPECT/CT images. 2. Incidence and severity of adverse events (AEs) and serious AEs (SAEs) monitoring throughout the study 3. Tolerability of AAA617 measured by AAA617 dose reductions, interruptions, discontinuations throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
Switzerland, United Kingdom
Contacts
Public Contact. Study Team
Outcome results
None listed