Radioactive 'Smart Bomb' targets Hard-to-Treat prostate cancer
NCT ID NCT03042468
First seen Jun 25, 2026 · Last updated Sep 15, 2026 · Updated 3 times
Summary
This study tests a radioactive drug called 177Lu-PSMA-617 in men with advanced prostate cancer that has stopped responding to hormone therapy. The drug seeks out and delivers radiation directly to cancer cells. The trial aims to find the safest effective dose and see if it can lower PSA levels. About 50 men are participating in this early-phase study.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 177Lu-PSMA-617 (a radioactive drug that targets prostate cancer cells)
- What this could lead to
- If it works, this could provide a new, targeted treatment option for men with advanced prostate cancer that has stopped responding to hormone therapy.
- What could go wrong
- This is an early-phase trial with only 50 participants, so results may not apply to everyone. The drug is radioactive and may cause side effects like dry mouth, fatigue, or low blood counts.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
50 people
The number who actually took part.
- Start date
-
Dec 2016
- Finished
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Jun 2026
- Lead sponsor
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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
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18 to 99 years
- Sex
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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: 1. Histologically or cytologically confirmed adenocarcinoma of prostate 2. Documented progressive metastatic CRPC based on Prostate Cancer Working Group 3 (PCWG3) criteria, which includes at least one of the following criteria: * PSA progression * Objective radiographic progression in soft tissue * New bone lesions 3. ECOG performance status of 0-2 4. Have serum testosterone \< 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH/GnRH analogue (agonist/antagonist) if they have not undergone orchiectomy. 5. Have previously been treated with at least one of the following: * Androgen receptor signaling inhibitor (such as enzalutamide) * CYP 17 inhibitor (such as abiraterone acetate) 6. Have previously received taxane chemotherapy, been determined to be ineligible for taxane chemotherapy by their physician, or refused taxane chemotherapy. 7. Age \> 18 years 8. Patients must have normal organ and marrow function as defined below: * Absolute neutrophil count \>2,000 cells/mm3 * Hemoglobin ≥9 g/dL (independent of transfusion and/or growth factors within 1 month prior to registration) * Platelet count \>150,000 x 109/uL (independent of transfusion and/or growth factors within 3 months prior to randomization) * Serum creatinine \<1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min/1.73 m2 by Cockcroft-Gault * Serum total bilirubin \<1.5 x ULN (unless due to Gilbert's syndrome in which case direct bilirubin must be normal * Serum AST and ALT \<1.5 x ULN 9. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Use of investigational drugs or implantation of investigational medical device ≤4 weeks of Cycle 1, Day 1 or current enrollment in investigational drug or device study 2. Prior systemic beta-emitting bone-seeking radioisotopes 3. Brain metastases or leptomeningeal disease 4. History of deep vein thrombosis and/or pulmonary embolus within 1 month of study entry 5. Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study 6. Radiation therapy for treatment of PCa ≤4 weeks of Day 1 Cycle 1 7. Patients on stable dose of bisphosphonates or denosumab, which have been started no less than 4 weeks prior to treatment start, may continue on this medication, however patients are not allowed to initiate bisphosphonate/Denosumab therapy during the DLT-assessment period of the study. 8. Having partners of childbearing potential and not willing to use a method of birth control deemed acceptable by the principle investigator and chairperson during the study and for 1 month after last study drug administration 9. Currently active other malignancy other than non-melanoma skin cancer. Patients are considered not to have "currently active" malignancy if they have completed any necessary therapy and are considered by their physician to be at less than 30% risk of relapse. 10. Known history of known myelodysplastic syndrome
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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
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Tulane Cancer Center Clinic
New Orleans, Louisiana, 70112, United States
-
Weill Cornell Medical College
New York, New York, 10021, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Training a Patient's own immune cells to fight advanced prostate cancer
- Radioactive missile aims at prostate cancer that spread
- New PET tracer targets ACP3 to spot prostate cancer
- Can a One-Week radiation course match four weeks for prostate cancer?
- Can a new PET tracer spot hidden prostate cancer spread?
- Can a gel cushion shield the rectum during prostate radiation?