New study checks kidney impact on prostate cancer drug safety
NCT ID NCT06004661
First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time
Summary
This study looks at how well the body handles a radioactive drug (lutetium vipivotide tetraxetan) in men with advanced prostate cancer that has spread and no longer responds to hormone therapy. Researchers want to see if different levels of kidney function change how the drug spreads and how safe it is. About 23 participants with normal, moderately, or severely reduced kidney function will be enrolled to measure radiation doses to organs and drug levels in the blood.
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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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23 people
The number who actually took part.
- Started
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Apr 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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 100 years
- 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.
Key Inclusion Criteria: 1. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 2. 68Ga-PSMA-11 Positron emission tomography (PET)/CT scan positive, and eligible as determined by the sponsor's central reader. 3. A castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L). 4. Documented progressive mCRPC will be based on at least 1 of the following criteria: * Serum/plasma Prostate-Specific Antigen (PSA) progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL * Soft-tissue progression defined as an increase \>= 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions. * Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan (2+2 PCWG3 criteria) 5. Documented stable chronic renal disease without evidence of further deterioration in renal function (stable chronic renal disease is defined as no significant change in renal function within 4 weeks prior to study entry. 6. Kidney function based on eGFR by Modification of Diet in Renal Disease (MDRD) equation: * Normal renal function: participants with eGFR \>= 90 mL/min/1.73m2 * Moderate renal impairment: participants with eGFR \>= 30 to =\< 59 mL/min/1.73m2 * Severe renal impairment: participants with eGFR \>= 15 to =\< 29 mL/min/1.73m2 Key Exclusion Criteria: 1. Previous treatment with PSMA-targeted radioligand therapy. 2. Previous treatment with any of the following within 6 months of enrollment confirmation: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation. 3. Use of agents known to prolong the QT interval from start of screening to end of Cycle 1, unless they can be permanently discontinued for the duration of study. 4. Current severe urinary incontinence, hydronephrosis, severe voiding dysfunction, any level of urinary obstruction requiring indwelling/condom catheters. Participants with postrenal impairment, like obstructions, retroperitoneal fibrosis (eg after prostatectomy) must be excluded or first resolved to ≤ Grade 1. 5. History or current diagnosis of ECG abnormalities indicating significant risk of safety for participants participating in the study such as: * Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, and clinically significant second- or third-degree AV block without a pacemaker. * History of familial long QT syndrome or known family history of Torsades de Pointe. * Resting heart rate (12 lead ECG) \<60 bpm Other protocol-defined inclusion/exclusion criteria may apply.
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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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Mount Sinai Hosp Med School
New York, New York, 10029, United States
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Novartis Investigative Site
Paris, 75014, France
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Novartis Investigative Site
Vandœuvre-lès-Nancy, 54511, France
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Novartis Investigative Site
Essen, 45147, Germany
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Novartis Investigative Site
München, 80377, Germany
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Novartis Investigative Site
Milan, 20141, Italy
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Novartis Investigative Site
Naples, 80131, Italy
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Novartis Investigative Site
Granada, Andalusia, 18014, Spain
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Novartis Investigative Site
El Palmar, Murcia, 30120, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Cancer-Targeting drug slow advanced prostate cancer?
- Can a smart radiation drug hunt down prostate cancer cells?
- Can a new daily pill slow advanced prostate cancer?
- Can a radioactive injection extend life in advanced prostate cancer?
- Chemo combo vs. radioactive drug: which tames aggressive prostate cancer?
- Can a new pill outsmart resistant prostate cancer?