Smart scans may boost prostate cancer radiation therapy
NCT ID NCT05924672
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tests whether using PSMA PET scans to select patients with castration-resistant prostate cancer that has spread to bones can improve the effectiveness of radium-223 therapy. Radium-223 is a radioactive drug that targets bone tumors. The study involves only 2 participants and measures how many achieve a significant drop in PSA levels. The goal is to see if better patient selection leads to better outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radium-223 (Ra-223)
- What this could lead to
- If successful, this could show that using PSMA PET scans to select patients leads to better tumor shrinkage with radium-223 therapy.
- What could go wrong
- This is a very small early-phase trial with only 2 participants, so results may not apply to larger groups. Radium-223 can cause bone marrow suppression and other side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
2 people
The number who actually took part.
- Started
-
Aug 2024
- Expected to finish
-
Mar 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of California, San Francisco
San Francisco, California, 94143, United States
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Other studies related to the condition(s) this trial covers.
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