Use of SPECT-CT for Comparison of Dosimetry Methods in PSMA-targeted Radioligand Therapy (SPECTacular Study) (SPECTacular)
Metastatic Castration-resistant Prostate Cancer
About this trial
This is an interventional diagnostic trial for Metastatic Castration-resistant Prostate Cancer
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male, 18 years old or older Histologically or pathologically confirmed prostate adenocarcinoma without predominant small cell component. Patient is receiving PSMA-targeted Radioligand Therapy (PRLT) for treatment of PSMA-positive tumor and/or metastases of prostate cancer. Therapy may be FDA approved or investigational in nature under an approved clinical trial. Ability to lay flat on scanner for duration of SPECT-CT imaging studies (1-2 hours) Exclusion Criteria: Assessment by the Investigator as unable or unwilling to comply with the requirements of the protocol. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥ 2 All criteria which may preclude a PSMA-radioligand therapy using Lu-177 PSMA-617 or Lu-177 PSMA I&T to be performed as per standardized guidelines and protocols laid down for these treatments and per decision by the treating physician.
Sites / Locations
- BAMF HealthRecruiting
Arms of the Study
Arm 1
Experimental
SPECT/CT
All patients enrolled will undergo 5 additional (6 total) SPECT/CT scans per treatment cycle. Current FDA approved PSMA radioligand therapy is administered over 6 cycles, so there will be a total of 30 additional SPECT/CT scans during this study. During each treatment cycle, patients will have a SPECT/CT scan at the following time points after administration of PRLT: 4 Hours 24 Hours (+/- 8 Hours) 48 Hours (+/- 8 Hours) 96 Hours (+/- 8 Hours) 168 Hours (+/- 24 Hours) 336 Hours (+/- 24 Hours)