Efficacy of Ra-223 in PSMA PET Optimally Selected Patients

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Jun 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how effective a treatment called Ra-223 is for men with advanced prostate cancer that has spread to the bones. The trial focuses on using a special type of scan called a PSMA PET scan, which helps identify patients who are most likely to benefit from Ra-223 therapy. Ra-223 is a radiation treatment that targets cancer cells in the bones and is given through an infusion into the veins. By using the PSMA PET scan, doctors hope to select the right patients who have the best chance of responding to this therapy.

To be eligible for the trial, participants must be men aged 18 and older who have prostate cancer that is no longer responding to hormone therapy and has spread to the bones, but not to other areas of the body. They should also meet certain health criteria, such as having a specific level of testosterone and a certain level of blood cells. Participants will receive the Ra-223 treatment and will be monitored throughout the study to see how well it works and what effects it has. This trial is currently recruiting participants, so if you or someone you know might qualify, it could be an opportunity to receive a potentially helpful treatment.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Male participants \>= 18 years of age on the day of signing informed consent
• • Castrate level of serum testosterone at study entry (\< 50 ng/dL), checked within three months of enrollment
• • Patient is a candidate for standard of care Ra-223 therapy
• • Bone only disease on PSMA PET using a Food and Drug Administration (FDA) approved PSMA targeted PET radiopharmaceutical
• • Note: Nodal disease on PSMA PET that is less than 1 cm in short axis and without evidence of change in size over the past six months on conventional imaging is allowed
• • Positivity on PSMA PET is defined as uptake greater than the liver that is not attributable to physiologic activity
• • Histologically confirmed prostate adenocarcinoma that is progressive by Prostate Cancer Working Group 3 (PCWG3) criteria at the time of study entry
• • Prior progression on at least one second generation androgen signaling inhibitor including abiraterone, apalutamide, darolutamide, and/or enzalutamide
• • Platelets \> 100,000/microliter (mcL)
• • Hemoglobin (Hgb) \> 9.0 g/dL
• • White blood cells (WBC) \> 2.5
• • Albumin \> 3.0 g/dL
• • Adverse events related to prior anti-cancer treatment must have recovered to =\< Grade 2
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
• • For patients who have partners of childbearing potential: Partner and/or patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principal investigator during the study and for 3 months after last study drug administration
• • Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
• • Ability to understand and the willingness to sign a written informed consent document
• Exclusion Criteria:
• • Prior treatment with Lutetium-177 (177Lu)-PSMA-617, Radium-223, Strontium-89, Samarium-153, Rhenium-186, Rhenium-188
• • Prior exposure to taxane-based chemotherapy.
• • \* Note: Exposure is defined as two or more cycles of taxane-based agents
• • Any systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy or biological therapy, including monoclonal antibodies) within 21 days prior to the first day of treatment
• • Greater than 75% bone involvement, based on PSMA PET
• • Presence of visceral metastases, untreated central nervous system metastases, or untreated epidural or spinal cord involvement
• • Prior treatment with radioligand therapy
• • Blood transfusion within past 45 days
• • Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures