Using PSMA PET scans to select patients for Ra-223 therapy in advanced prostate cancer
Efficacy of Ra-223 in PSMA PET Optimally Selected Patients
This study is testing whether PSMA PET scans can help find the right patients with advanced prostate cancer for treatment with Ra-223 radiation therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of California, San Francisco Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05924672 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the effectiveness of using prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scans to identify patients with castration-resistant prostate cancer that has spread to the bones for treatment with Ra-223 radiation therapy. Participants will undergo PSMA PET scans and bone scans to assess their eligibility for Ra-223, which is administered intravenously. The study aims to evaluate the PSA response rates, overall survival, and safety profile of Ra-223, as well as to compare imaging responses using different scanning techniques. Blood samples will be collected throughout the treatment to monitor patient responses.
Who should consider this trial
Good fit: Ideal candidates are male patients aged 18 and older with castration-resistant prostate cancer that has metastasized to the bones.
Not a fit: Patients with significant nodal disease or those who have not progressed on second-generation androgen signaling inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment selection and outcomes for patients with advanced prostate cancer.
How similar studies have performed: Other studies have shown promise in using imaging techniques for patient selection in cancer therapies, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Thomas A Hope, MD — University of California, San Francisco
- Study coordinator: Maya Aslam
- Email: Maya.Aslam@ucsf.edu
- Phone: 877-827-3222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.