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Radiopharmaceutical
Ra-223 for Prostate Cancer
Phase 2
Waitlist Available
Led By Thomas A Hope, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial studies if using PSMA PET scans to select patients for Ra-223 radiation therapy is effective in treating prostate cancer that has spread to bones.
Who is the study for?
This trial is for men aged 18+ with castration-resistant prostate cancer that has spread to bones, but not beyond. They must have low testosterone levels and be in fairly good health overall. Participants need a positive PSMA PET scan result and can't have had certain previous cancer treatments or high bone involvement by the cancer.
What is being tested?
The study tests if PSMA PET scans are effective in selecting patients who would benefit from Ra-223 radiation therapy. Ra-223 targets bone metastases from prostate cancer. The trial will assess how well this targeted radiation works after identifying tumor activity through advanced imaging techniques.
What are the potential side effects?
Potential side effects of Ra-223 include nausea, diarrhea, blood cell count changes leading to anemia or infection risks, and symptoms related to where the radiation is absorbed in the body such as bone pain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
PSA50 response rate
Secondary study objectives
Compare the lesion based PSMA PET response based on paired NaF PET / MDP uptake
Overall Survival
PSA30 response rate
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (NaF PET/CT/MDP, Ra-223, PSMA PET)Experimental Treatment3 Interventions
Patients undergo NaF PET/CT or MDP scan within 45 days prior to cycle 1 day 1. Patients then receive standard of care Ra-223 IV on day 1 of each cycle. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo PSMA PET/CT over 45-60 minutes between 30-60 days after the last dose of Ra-223. Patients also undergo collection of blood samples during screening, on day 1 of every Ra-223 cycle, and at 30 days after the last dose of Ra-223. Patients may also undergo NaF PET/CT or MDP scans during Ra-223 treatment as clinically indicated, and/or CT scans during screening and Ra-223 treatment as clinically indicated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radium-223
2023
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,586 Previous Clinical Trials
14,899,992 Total Patients Enrolled
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering PharmaIndustry Sponsor
25 Previous Clinical Trials
122,101 Total Patients Enrolled
Thomas A Hope, MDPrincipal InvestigatorUniversity of California, San Francisco
4 Previous Clinical Trials
503 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is only in the bones, confirmed by a special PET scan.I am a man aged 18 or older.I can take care of myself and am up and about more than half of my waking hours.My cancer progressed despite treatment with drugs like abiraterone.My prostate cancer is getting worse according to specific criteria.I have undergone at least two cycles of chemotherapy that included a taxane.I am eligible for Ra-223 cancer treatment.My testosterone levels are very low, as confirmed by a recent test.My side effects from previous cancer treatments are mild.My cancer has spread to my organs or brain/spine and hasn't been treated there.I have previously been treated with specific radioactive medications.I have not had a blood transfusion in the last 45 days.I have previously undergone radioligand therapy.I have another cancer type, but it won't affect this trial's treatment.I haven't had any cancer treatments like chemotherapy or immunotherapy in the last 3 weeks.Over 75% of my bones are affected, as shown by a PSMA PET scan.My cancer has spread to lymph nodes, but they are small and haven't grown in 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (NaF PET/CT/MDP, Ra-223, PSMA PET)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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