New study checks kidney impact on prostate cancer drug safety

NCT ID NCT06004661

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

23 people

The number who actually took part.

Started

Apr 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 100 years

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

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

  • Mount Sinai Hosp Med School

    New York, New York, 10029, United States

  • Novartis Investigative Site

    Paris, 75014, France

  • Novartis Investigative Site

    Vandœuvre-lès-Nancy, 54511, France

  • Novartis Investigative Site

    Essen, 45147, Germany

  • Novartis Investigative Site

    München, 80377, Germany

  • Novartis Investigative Site

    Milan, 20141, Italy

  • Novartis Investigative Site

    Naples, 80131, Italy

  • Novartis Investigative Site

    Granada, Andalusia, 18014, Spain

  • Novartis Investigative Site

    El Palmar, Murcia, 30120, Spain

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