Radioactive antibody combo aims to stop prostate cancer spread
NCT ID NCT00859781
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether a radioactive antibody called 177Lu-J591, combined with the hormone-blocking drug ketoconazole, can prevent prostate cancer from spreading in high-risk patients. The study enrolls 55 men whose PSA is rising despite hormone therapy but who have no visible metastases. The main goal is to see how many remain free of detectable spread after 18 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 177Lu-J591 (a radioactive antibody) and ketoconazole (a hormone-blocking drug)
- What this could lead to
- If this works, it could offer a new way to delay or prevent the spread of prostate cancer in high-risk patients whose PSA is rising despite hormone therapy.
- What could go wrong
- This is a small, early-phase trial with only 55 participants, so results may not apply to everyone. The combination therapy can cause side effects like low blood counts and fatigue.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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55 people
The number who actually took part.
- Started
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Jun 2009
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- 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 years and older
- Sex
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Male participants only
- Healthy volunteers
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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: * Histologically or cytologically confirmed adenocarcinoma of the prostate previously treated with surgery and/or radiotherapy. * Biochemical progression (rising PSA) after medical or surgical castration * High risk of systemic progression defined as: 1. Rising PSA as defined above and either: 2. Absolute PSA \> 20 ng/mL AND/OR 3. PSA doubling time \< 8 months * No evidence of local recurrence or distant metastases * Age \>18 years. * Serum testosterone \< 50 ng/ml * Patients capable of fathering children must agree to use an effective method of contraception for the duration of the trial. * Subjects on bisphosphonate therapy must be on a stable dose and must have started therapy \> 4 weeks prior to protocol therapy. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Use of red blood cell or platelet transfusions within 4 weeks of treatment * Use of hematopoietic growth factors within 4 weeks of treatment * Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment * Prior radiation therapy encompassing \>25% of skeleton (see Appendix C) * Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®) * Platelet count \<150,000/mm3 or known primary qualitative platelet disorder * Absolute neutrophil count (ANC) \<2,000/mm3 * Hematocrit \<30 percent and Hemoglobin \< 10 g/dL * Abnormal coagulation profile (PT or INR, PTT \> 1.3x ULN) unless on therapeutic anticoagulation - see concomitant meds section * Serum creatinine \>2.5 mg/dL * AST (SGOT) \>2x ULN * Bilirubin (total) \>1.5x ULN; subjects with Gilbert's syndrome will be allowed if direct bilirubin is within institutional normal limits * Active serious infection * Active angina pectoris or NY Heart Association Class III-IV * ECOG Performance Status \> 2 * Life expectancy \<12 months * History of deep vein thrombosis and/or pulmonary embolus within 1 month of study entry * 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 * Prior investigational therapy (medications or devices) within 4 weeks of treatment. Furthermore, other investigational therapy is not permitted during the treatment phase. * Prior use of ketoconazole for the purposes of prostate cancer therapy for greater than 1 month * Known history of HIV. The effects of J591 are unknown in this population. Furthermore, ketoconazole has many well-described drug-drug interactions which could affect antiviral therapy. If necessary, this population will be studied separately. * 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. \- Known history of known myelodysplastic syndrome * Adrenal hormone inhibitors (other than ketoconazole) within 4 weeks prior to study enrollment * Finasteride (Propecia® or Proscar®) or dutasteride (Avodart®) within 4 weeks of enrollment * Patients on corticosteroids prior to enrollment must have either discontinued and shown biochemical progression or have biochemical progression on a stable dose
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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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Cedars Sinai
Los Angeles, California, 90048, United States
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Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
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Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
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The University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
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UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
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USC/Norris Comprehensive cancer center
Los Angeles, California, 90089, United States
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University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
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University of Utah
Salt Lake City, Utah, 84108, United States
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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.
- 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?
- A scanner in the operating room could show surgeons exactly where prostate cancer remains