At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- AAA817 (drug), ARPI (drug), Standard of Care (drug)
- How long the study runs
- Study runs about 88 months (dates as stated)
- About the drug or intervention
- AAA817 — drug: AAA817 is being studied for treating PSMA positive mCRPC. · ARPI — drug: Androgen receptor pathway inhibitor (ARPI): An ARPI is approved for the treatment of prostate cancer. · Standard of Care — drug: Standard treatment includes approved treatment for mCRPC.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 100 Years
- Who
- Male
- Number of participants
- 940
- Started
- 2025-07-01
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for prostate cancer
- • Phase3 - 940 participants
- • The purpose of this study is to determine whether \[225Ac\]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +/- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator's choice of standard of care (SOC) (ARPI change or taxane-based chemotherapy or \[177Lu\]Lu-PSMA-617 (AAA617)) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) treated with another ARPI as last treatment and who have not been exposed to a taxane-containing chemotherapy in the mCRPC setting nor have received any prior PSMA-targeting radioligand therapy
Who can take part?
- • Ages 18 Years to 100 Years
- • Diagnosed with prostate cancer
- • Male only
Where?
- • Oxford - Novartis Investigative Site
- • Sutton - Novartis Investigative Site
- • Windsor - Novartis Investigative Site
- • London - Novartis Investigative Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this study is to determine whether \[225Ac\]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +/- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator's choice of standard of care (SOC) (ARPI change or taxane-based chemotherapy or \[177Lu\]Lu-PSMA-617 (AAA617)) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) treated with another ARPI as last treatment and who have not been exposed to a taxane-containing chemotherapy in the mCRPC setting nor have received any prior PSMA-targeting radioligand therapy.
More detail
This is a phase III, open label, multicenter randomized study. The study aims at evaluating the superiority of 225Ac-PSMA-617 combined with androgen receptor pathway inhibitor (ARPI) over a change of ARPI or chemotherapy or \[177Lu\]Lu-PSMA-617 (AAA617) in prolonging progression free survival (rPFS). Screening period: At screening, the participants will be assessed for eligibility and will undergo a positron emission tomography (PET)/computed tomography (CT) scan to evaluate PSMA positivity. Only participants with PSMA positive cancer and confirmed eligibility criteria will be randomized. Participants randomized to the investigational arms will receive up to 6 doses of AAA817 10 Mbq +/- 10% given intravenously with or without an ARPI (oral enzalutamide or oral abiraterone) per investigator's choice. Treatment with ARPI should continue as per protocol end of treatment criteria. Participants randomized to SoC will be treated with an ARPI change (oral enzalutamide or oral abiraterone) or taxane-based chemotherapy (docetaxel or cabazitaxel) or \[177Lu\]Lu-PSMA-617 (AAA617)' per investigator's choice. Treatment with ARPI should continue as per protocol end of treatment criteria. Treatment duration with taxane-based chemotherapy or AAA617will depend on the chosen regimen per the investigator's discretion following local guidelines as per standard of care and product labels and adhere to the protocol end of treatment criteria. Supportive care will be allowed in both arms at the discretion of the investigator and includes available care for the eligible participant according to best institutional practice for mCRPC treatment, including androgen deprivation therapy (ADT). Safety will be assessed routinely during the study. Crossover is not allowed among study arms. The study will be conducted in the USA among other countries globally.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 100 Years
- Who can join: Male only
- How fit you need to be: ECOG 0 or better
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ an ECOG performance status of 0 to 2
- ✓ histological, and/or cytological confirmation of adenocarcinoma of the prostate
- ✓ PSMA-PET positive disease using a PSMA imaging agent that is approved as per protocol
What the study is looking for
- ✓Signed agreement to take part must be obtained prior to participation in the study.
- ✓Participants must be adults ≥ 18 years of age.
- ✓Participants must have an Fit enough for normal activity (ECOG 0) to 2.
- ✓Participants must have histological, and/or cytological confirmation of adenocarcinoma of the prostate. Participants...
- ✓Participants must not have received taxane-based drug treatment in mCRPC setting (allowed in mHSPC setting).
Who cannot take part
- ✗Previous anti-cancer treatment with any approved or investigational radiopharmaceuticals (for example,...
- ✗Previous treatment with any external beam radiotherapy including hemi-body radiation within 6 weeks of randomization...
- ✗Note: Prior ARPI administered in the mHSPC setting or earlier may continue until C1D1.
- ✗Other protocol-defined inclusion/exclusion criteria may apply.
See the full criteria
Where Is This Study? (4 UK sites)
Novartis Investigative Site
Oxford OX4 6LB, United Kingdom
Novartis Investigative Site
Sutton SM2 5PT, United Kingdom
Novartis Investigative Site
Windsor SL4 3HD, United Kingdom
Novartis Investigative Site
London EC1A 7BE, United Kingdom
How to Get in Touch
Novartis Pharmaceuticals
Sponsor contactCONTACT
Novartis Pharmaceuticals
Sponsor contactCONTACT
