Efficacy of Ra-223 in PSMA PET Optimally Selected Patients
NCT05924672 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2026-01-14
Summary
This phase II trial studies how well prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scans (in combination with bone scans) work in selecting patients for Ra-223 radiation therapy that have castration-resistant prostate cancer that has spread from where it first started (primary site) to the bones (bone metastasis). Ra-223 is a type of therapy that emits radiation. Radiation gives off energy which can kill tumor cells and other cells that may support the tumor cells. Ra-223 is given by infusion into the veins, where it is absorbed by the bones. PSMA PET is a type of scan used to detect prostate cancer tumors. PSMA is a radioactive tracer that binds to a specific protein that is found on prostate tumor cells. The PSMA tracer shows the areas on the PET scan where tumor cells are active. A PET scan uses a special camera to detect the energy given off from radioactive tracers (such as PSMA) to make detailed pictures of areas where the tracer accumulates in the body. The PET scan is often combined with a magnetic resonance imaging (MRI) or computed tomography (CT) scan, which helps to map the locations where PSMA has accumulated. PSMA PET scans may be able to select patients that will benefit the most from Ra-223 treatment.
Conditions
- Castration-Resistant Prostate Carcinoma
- Metastatic Malignant Neoplasm in the Bone
- Stage IVB Prostate Cancer AJCC v8
Interventions
- DRUG
-
Radium-223
Given IV
- PROCEDURE
-
PSMA Positron Emission Tomography (PET) Scan
Undergo PSMA PET/CT
- DRUG
-
Technetium Tc 99M Medronate
Undergo MDP
Sponsors & Collaborators
-
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
collaborator INDUSTRY -
University of California, San Francisco
lead OTHER
Principal Investigators
-
Thomas A Hope, MD · University of California, San Francisco
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-30
- Primary Completion
- 2026-01-07
- Completion
- 2027-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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