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Looking for participantsPhase3

Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC

Sponsor: Novartis Pharmaceuticals

NCT ID: NCT06855277

View on ClinicalTrials.gov ↗

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.

Prostate Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

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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

PET positive

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
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 of 0 to 2. * Participants must have histological, and/or cytological confirmation of adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible. * Participants who have received taxane-based chemotherapy in mHSPC setting are eligible if they are deemed appropriate for chemotherapy, ARPI change or AAA617 as the next line of therapy in the opinion of the Investigator. Note: Participants who have received taxane-based chemotherapy for mCRPC are excluded. * Participants must not have received taxane-based chemotherapy in mCRPC setting (allowed in mHSPC setting). * Participants must have PSMA-PET positive disease using a PSMA imaging agent that is approved as per protocol. * Participant must have been diagnosed with mCRPC with documented progressive disease while on treatment with ARPI in mHSPC or earlier setting as their last treatment (and did not progress on more than one ARPI). * Participants with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer, as per local testing, may be enrolled if they had prior exposure to PARPi. Key Exclusion Criteria: * Previous anti-cancer treatment with any approved or investigational radiopharmaceuticals (for example, \[177Lu\]Lu-PSMA, \[177Lu\]-DOTA, or Radium- 223.) * Previous treatment with any external beam radiotherapy including hemi-body radiation within 6 weeks of randomization (within 2 weeks for radiotherapy of localized metastases). * 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. Other protocol-defined inclusion/exclusion criteria may apply.

Where Is This Study? (4 UK sites)

Novartis Investigative Site

Oxford OX4 6LB, United Kingdom

Recruiting

Novartis Investigative Site

Sutton SM2 5PT, United Kingdom

Recruiting

Novartis Investigative Site

Windsor SL4 3HD, United Kingdom

Recruiting

Novartis Investigative Site

London EC1A 7BE, United Kingdom

Recruiting

How to Get in Touch

Novartis Pharmaceuticals

Sponsor contact

CONTACT

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

Sponsor contact

CONTACT

+41613241111
Data sourced from ClinicalTrials.gov · Last verified: 2026-09