Active — Not RecruitingPhase 2

Efficacy of Ra-223 in PSMA PET Optimally Selected Patients

United States2 participantsStarted 2024-08-30

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

What they're measuring

PSA50 response rate

Timeframe: Up to 6 months

Trial details

NCT IDNCT05924672

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-07