Clareo Health | An External Control Arm Study Comparing Survival Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With 177Lu-PSMA-617 vs Androgen Receptor Pathway Inhibitor (ARPI) Switch in Routine Care
An External Control Arm Study Comparing Survival Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With 177Lu-PSMA-617 vs Androgen Receptor Pathway Inhibitor (ARPI) Switch in Routine Care
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–100
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
1. Had an International Classification of Diseases, 9th or 10th Revision, Clinical Modification (ICD-9-CM or ICD-10-CM) diagnosis of prostate cancer (PC) (ICD-9-CM 185x or ICD-10-CM C61x).
2. Had at least two documented clinical visits, on different days, occurring on or after 01 Jan 2013.
3. Included in probabilistic sample of patients queued for review via abstraction.
4. Had diagnosis of metastatic disease on or after 01 Jan 2013.
5. Histology was confirmed as adenocarcinoma of the prostate.
6. Had confirmed mCRPC diagnosis.
7. Treated with an ARPI-containing line of therapy (LOT; i.e., index therapy) in the mCRPC setting immediately after progression on one previous ARPI-containing line (in any setting, Hormone Sensitive PC or castration-resistant PC), as defined per the health research database's LOT rules and confirmed via abstraction.
8. 18 years of age or older at the start of index therapy.
9. Had an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0-1 within 30 days before or up to 7 days after index date, or unknown ECOG PS.
You may not be if
1. Female sex.
2. Had evidence of untreated brain metastases.
3. Had history of cardiac comorbidities, infection with hepatitis B or C, or spinal cord compression that would indicate significant risk to PSMAfore trial participation.
4. Diagnosis of an active additional malignancy (i.e., other than prostate cancer).
5. Evidence of biomarker status that would indicate eligibility for treatment other than ARPI, or better prognosis.
6. Evidence of prior treatment with therapies that potentially affect study outcomes (e.g., radiopharmaceuticals, taxane, immunotherapy or biological therapy, clinical study drug (CSD), or 177Lu-PSMA-617).
7. Had evidence of inadequate organ function.
8. Had evidence of low levels of albumin (\< 2.5 g/dL).
