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Evaluating safety and tolerability of a new treatment for advanced prostate cancer

A Phase I, Open-label, Multi-center Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer

PHASE1 · Novartis · NCT06531499

This study is testing a new treatment for advanced prostate cancer to see if it's safe and tolerable for men who haven't had chemotherapy before.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment106 (estimated)
Ages18 Years to 100 Years
SexMale
SponsorNovartis (industry)
Drugs / interventionschemotherapy, immunotherapy, methotrexate
Locations21 sites (Los Angeles, California and 20 other locations)
Trial IDNCT06531499 on ClinicalTrials.gov

What this trial studies

This study assesses the safety, tolerability, and radiation dosimetry of up to 12 cycles of AAA617 in adults with metastatic castration-resistant prostate cancer who have not previously received chemotherapy. Participants will undergo screening to confirm PSMA positivity and will receive treatment every six weeks, with follow-up assessments including PSMA-PET scans to monitor treatment response and safety. The study aims to gather important data on the effects of this novel treatment approach in a specific patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with PSMA-positive metastatic castration-resistant prostate cancer who have progressed on prior ARPI treatment.

Not a fit: Patients who have received chemotherapy or have significant renal impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced prostate cancer who have limited treatment choices.

How similar studies have performed: Other studies have shown promise with similar PSMA-targeted therapies, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Signed informed consent must be obtained prior to participation in the study.
* Participants must be adults ≥ 18 years of age.
* Participants must have an ECOG performance status ≤ 1.
* Participants must have histological confirmation of adenocarcinoma of the prostate.
* Participants must be PSMA-positive per 68Ga-PSMA PET/CT scans at baseline
* Participants must have a castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L) either by pharmaceutical or surgical methods.
* Participants must have progressed only once on prior second generation ARPIs
* Documented progressive mCRPC
* Participants must have ≥ 1 metastatic lesion by conventional imaging that is present on screening/baseline CT, MRI, or bone scan
* Renal: eGFR ≥ 60 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
* Participants must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies except alopecia.

Key exclusion Criteria:

* Previous treatment with any of the following within 6 months of study enrollment: Strontium 89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation
* Any previous radioligand therapy.
* Prior treatment with cytotoxic chemotherapy for metastatic castration-resistant or metastatic hormone-sensitive prostate cancer (mHSPC) (e.g., taxanes, platinum, estramustine, vincristine, methotrexate, etc.), immunotherapy or biological therapy \[including monoclonal antibodies\]. \[Note: Taxane exposure (maximum 6 cycles) in the adjuvant or neoadjuvant setting is allowed if 12 months have elapsed since completion of this adjuvant or neoadjuvant therapy. Prior treatment with sipuleucel-T is allowed\].
* Concurrent therapies: cytotoxic chemotherapy, immunotherapy, radioligand therapy, PARP inhibitor, biological, or investigational therapy
* History of myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature and/or clinically active significant cardiac disease
* Concurrent serious acute or chronic nephropathy and/or moderate to severe renal impairment as determined by the principal investigator.
* Diagnosed with other active malignancies that are expected to alter life expectancy or may interfere with disease assessment
* Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 14 weeks after stopping study treatment.
* Concurrent urinary outflow obstruction or unmanageable urinary incontinence
* History of somatic or psychiatric disease/condition that may interfere with the aims and assessments of the study.

Other protocol-defined inclusion/exclusion criteria may apply.

Where this trial is running

Los Angeles, California and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Metastatic Castration-Resistant Prostate Cancer, Phase 1, RADIODOSE, AAA617, metastatic castration-resistant prostate cancer, radiation dosimetry, mCRPC, Prostate-specific membrane antigen

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.