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Evaluating AAA617 alone and with ARPI for advanced prostate cancer

An International Prospective Open-label, Multi-center, Randomized, Non-comparative Phase II Study of Lutetium [177Lu] Vipivotide Tetraxetan (AAA617) Alone and Lutetium [177Lu] Vipivotide Tetraxetan (AAA617) in Combination With Androgen Receptor Pathway Inhibitors in Patients With PSMA PET Scan Positive Castration-Resistant Prostate Cancer

Phase 2 Interventional Novartis · NCT05849298

This study is testing a new treatment called AAA617, alone and with another drug, to see if it helps men with advanced prostate cancer that hasn't spread and is resistant to other therapies.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment120 (estimated)
Ages18 Years to 100 Years
SexMale
SponsorNovartis Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations47 sites (Mobile, Alabama and 46 other locations)
Trial IDNCT05849298 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and effectiveness of AAA617, a targeted therapy, both alone and in combination with androgen receptor pathway inhibitors (ARPI), in patients with prostate cancer that is positive for PSMA and resistant to castration. Approximately 120 participants will be randomized to receive either treatment, focusing on those who show no signs of metastasis in conventional imaging. The study will utilize advanced imaging techniques to confirm the presence of PSMA-positive disease and monitor treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates include adult males aged 18 and older with confirmed prostate cancer, ongoing androgen deprivation therapy, and PSMA-positive disease without evidence of metastasis.

Not a fit: Patients with metastatic disease evident on conventional imaging or those who do not meet the PSMA positivity criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced prostate cancer that is resistant to standard therapies.

How similar studies have performed: Other studies have shown promising results with similar targeted therapies in prostate cancer, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion criteria

* Participants must be adults ≥ 18 years of age with signed informed consent prior to participation to study
* Histologically or cytologically confirmed prostate cancer
* Participants must have ongoing androgen deprivation therapy with a GnRH agonist/antagonist or prior bilateral orchiectomy
* Castrate level of serum testosterone (\< 1.7 nmol/l \[50 ng/dl\]) on GnRH agonist or antagonist therapy or after bilateral orchiectomy
* Participants must have evidence of PSMA-positive disease as seen on a AAA517 or piflufolastat F 18 PET/CT scan at baseline as determined by Blinded Independent Central Review (BICR) based on the methodology proposed in the Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE) (Eiber et al 2018). Participants with M1 disease only on PSMA PET scan are allowed to participate
* Participants must have a negative conventional imaging for M1 disease.
* PSA Doubling Time (PSADT) of ≤ 10 months
* Participants must have adequate organ functions: bone marrow reserve, hepatic \& renal

Key Exclusion criteria

* Prior or present evidence of metastatic disease as assessed by CT/MRI locally for soft tissue disease and whole-body radionuclide bone scan for bone disease. Exception: Participants with soft tissue pelvic disease may be eligible (e.g., participants with enlarged lymph nodes below the aortic bifurcation (N1) are eligible if the short axis of the largest lymph node is \<20 mm)
* Unmanageable concurrent bladder outflow obstruction or urinary incontinence. Note: participants with bladder outflow obstruction or urinary incontinence, which is manageable with best available standard of care (incl. pads, drainage) are allowed
* Active clinically significant cardiac disease; history of seizure or condition that may pre-dispose to seizure which may require treatment with surgery or radiation therapy
* Prior therapy with: second generation anti-androgens (e.g., enzalutamide, apalutamide and darolutamide); CYP17 inhibitors (e.g., abiraterone acetate, orteronel, galeterone, ketoconazole; radiopharmaceutical agents (e.g., Strontium-89), PSMA-targeted radioligand therapy; immunotherapy (e.g., sipuleucel-T); chemotherapy, except if administered in the adjuvant/neoadjuvant setting, completed \> 2 years before randomization; any other investigational agents for CRPC; use of estrogens, 5-α reductase inhibitors (finasteride, dutasteride), other steroidogenesis inhibitors (aminoglutethimide) or first-generation anti-androgens (bicalutamide, flutamide, nilutamide, cyproterone) within 28 days before randomization; radiation therapy (external beam radiation therapy \[EBRT\] and brachytherapy within 28 days before randomization
* Other concurrent cytotoxicity chemotherapy, immunotherapy, radioligand therapy, poly adenosine diphosphate-ribose polymerase (PARP) inhibitor, biological therapy or investigational therapy

Other protocol-defined inclusion/exclusion criteria may apply.

Where this trial is running

Mobile, Alabama and 46 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 → Find more trials like this →
Conditions Prostatic NeoplasmProstate-specific membrane antigenLutetium [177Lu] vipivotide tetraxetanAndrogen Receptor Pathway InhibitorsEnzalutamideDarolutamideApalutamideCastration Resistant Prostate Cancer
Last reviewed 2026-06-15 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.