Tests a radioactive PSMA drug with hormone therapy in advanced prostate cancer
Tests a radioactive drug plus hormone therapy in men with advanced prostate cancer.
Plain-language title generated from the registry record
Registry title: Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC
Key facts
- Where
- Mexico City, MexicoSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer that has spread, no longer responds to hormone-lowering treatment and shows up on a PSMA scan. They must have progressed on an ARPI as their last treatment.
- Age
- 18 Years to 100 Years
- Sex
- Men only
- Disease stage
- Metastatic castration-resistant prostate cancer (mCRPC) with PSMA-positive disease on a PSMA-PET scan. The cancer must be adenocarcinoma of the prostate, confirmed by tissue or cell tests.
- Earlier treatment
- The disease must have progressed on an ARPI as the last treatment, and not on more than one ARPI. Prior taxane chemotherapy for mHSPC is allowed. Prior taxane chemotherapy for mCRPC, and any prior radiopharmaceutical such as [177Lu]Lu-PSMA, [177Lu]-DOTA or Radium-223, are not allowed.
- Biomarker or test result
- PSMA-positive disease on PSMA-PET. People with a harmful HRR gene mutation can join if they had a PARP inhibitor before.
Main reasons for not taking part
- Mixed histology (neuroendocrine) prostate cancer
- Taxane chemotherapy for mCRPC
- Any prior radiopharmaceutical, for example [177Lu]Lu-PSMA, [177Lu]-DOTA or Radium-223
- External beam radiotherapy within 6 weeks of randomization (2 weeks for localized metastases)
- Prior PARP inhibitor or other systemic cancer therapy for mCRPC
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Source: NCT06855277, who can take part
Where in Mexico
- Mexico CityMexico City, MexicoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT06855277
- Record updated
- 15 October 2026
- Original description
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.Read full original descriptionShow less
A 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
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.
Inclusion: 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.
Exclusion: 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.