Recruiting

AcTFirstAAA817 and ARPI for PSMA-positive Metastatic Castration Resistant Prostate Cancer

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What is being tested

AAA817

+ ARPI

+ Standard of Care

Drug
Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

From 18 to 100 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Phase 3
Interventional
Study Start: July 2025
See protocol details

Summary

Principal SponsorNovartis Pharmaceuticals
Study ContactNovartis PharmaceuticalsMore contacts
Last updated: February 7, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2025

Actual date on which the first participant was enrolled.

This study is designed to see if a new treatment called 225Ac-PSMA-617, when combined with either enzalutamide or abiraterone, is more effective than the current standard treatments for adult men with a type of prostate cancer known as PSMA-positive metastatic castration-resistant prostate cancer. The main goal is to find out if this new treatment can help patients live longer without the cancer getting worse. This is important because finding more effective treatments can improve the quality of life and outcomes for patients who have few options due to the advanced stage of their cancer. Participants in the study will first undergo scans to confirm their eligibility and ensure their cancer is PSMA-positive. Those who qualify will be randomly assigned to receive either the new treatment of 225Ac-PSMA-617 through an IV infusion, potentially with oral ARPI medications, or the standard care treatment, which could involve other oral ARPI drugs or chemotherapy. The study will closely monitor the safety of the treatments and measure how long patients go without their cancer progressing. Supportive care, including therapies to reduce certain hormone levels, is available to all participants as needed. The study does not allow switching between treatment groups, and safety checks are a routine part of the process.

Official TitleA Phase III, Open-label, Multi-center, Randomized Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate Cancer
NCT06855277
Principal SponsorNovartis Pharmaceuticals
Study ContactNovartis PharmaceuticalsMore contacts
Last updated: February 7, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

940 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesProstatic NeoplasmsUrogenital NeoplasmsMale Urogenital Diseases

Criteria

9 inclusion criteria required to participate
Signed informed consent must be obtained prior to participation in the study.

Participants must not have received taxane-based chemotherapy in mCRPC setting (allowed in mHSPC setting).

Participants must have histological, and/or cytological confirmation of adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible.

Participants must have PSMA-PET positive disease using a PSMA imaging agent that is approved as per protocol.

Show More Criteria

4 exclusion criteria prevent from participating
Previous treatment with any external beam radiotherapy including hemi-body radiation within 6 weeks of randomization (within 2 weeks for radiotherapy of localized metastases).

Other protocol-defined inclusion/exclusion criteria may apply.

Previous anti-cancer treatment with any approved or investigational radiopharmaceuticals (for example, [177Lu]Lu-PSMA, [177Lu]-DOTA, or Radium- 223.)

Any prior PARP inhibitor or other systemic anticancer therapy administered for metastatic castration-resistant prostate cancer (mCRPC). Any other approved or investigational systemic therapy (including chemotherapy, immunotherapy, biologics, or monoclonal antibodies) is prohibited within 28 days or 5 half-lives (whichever is shorter) before randomization. Note: Prior ARPI administered in the mHSPC setting or earlier may continue until C1D1.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive AAA817 infusion directly into a vein.

Group II

Experimental
Participants will receive AAA817 infusion directly into a vein with ARPIs.

Group III

Active Comparator
Participants will receive standard treatment as decided by the trial doctor either as a taxane-based chemotherapy infusion directly into a vein or ARPI change either as capsules or tablets or AAA617 monotherapy infusion directly into a vein.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 50 locations

Recruiting

Rocky Mountain Cancer Centers

Denver, United StatesOpen Rocky Mountain Cancer Centers in Google Maps
Recruiting

Miami Cancer Institute at Bapt

Miami, United States
Recruiting

Univ Of Iowa Hospitals And Clinics

Iowa City, United States
Recruiting

University of Kansas Hospital

Kansas City, United States
Recruiting
50 Study Centers