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An Open-label Dosimetry, Tolerability and Safety Study of lutetium (177Lu) vipivotide tetraxetan in Patients with Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) with Moderately and Severely Impaired and with Normal Renal Function
EU CTIS ID: 2023-503925-20-00
What this study is testing
To assess potential impact of moderate and severe renal impairment on the dosimetry, biodistribution (PK), safety and tolerability of AAA617
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- 68Ga-PSMA-11 Positron emission tomography (PET)/CT scan positive, and eligible as determined by the sponsor’s central reader
- A castrate level of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L).
- 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, Scher et al 2016).
- 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 as documented by ≤ 20% difference between two separate eGFR measurements calculated with the MDRD equation. In addition, all eGFR values available within 3 months prior to study entry should be classified in the same eGFR category as the calculated eGFR at screening).
- Kidney function based on eGFR by Modification of Diet in Renal Disease (MDRD) equation (at first screening assessment): • 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
You likely can't join if
- Previous treatment with PSMA-targeted radioligand therapy.
- 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.
- 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.
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.