NCT06780670Recruiting
Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy
Summary
This is a Phase II/III study. Patient population is adult participants with PSMA-positive mCRPC who had treatments with androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy and progressed on or after \[177Lu\]Lu-PSMA targeted therapy. Treatment of interest: the investigational treatment is AAA817 regardless of subsequent anti-neoplastic treatment. The control treatment is investigator's choice of Standard of Care, regardless of subsequent anti-neoplastic treatment
Inclusion criteria
∙ • adults ≥ 18 years of age. • ECOG performance status of 0 to 2. • histopathological and/or cytological confirmation of adenocarcinoma of the prostate. • PSMA-positive disease as assessed by PSMA PET/CT scan using an approved PSMA imaging agent as protocol instructed, • castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L). • Prior treatments with an androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy, and progressed on or after \[177Lu\]Lu-PSMA targeted therapy. • ≥ 1 metastatic lesion that is present on screening/baseline CT, MRI, or bone scan imaging obtained ≤ 28 days prior to randomization • eGFR as requested by the sponsor
Exclusion criteria
• Any investigational agents within 28 days prior to the day of randomization. • Any 225Ac-based investigational compound used prior to the day of randomization. • Participants with a history of CNS metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity. • Concurrent acute kidney injury (renal failure developed between 48 hours to 7 days) or chronic kidney disease (at least 3 months of ongoing renal injury) • Baseline xerostomia ≥ Grade 2 by CTCAE v.5 • History of uncontrolled hypertension, myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature and/or clinically active significant cardiac disease • History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 2 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, non-invasive malignant colon polyps that have been removed). Other protocol-defined inclusion/exclusion criteria may apply.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 2 · Phase 3
- Study type
- Interventional
- Countries
- Switzerland, United States, Australia, Brazil, China, Hong Kong, Israel, Japan, Malaysia, Mexico, Singapore, South Korea, Taiwan
- Sponsor
- Novartis Pharmaceuticals(Industry)
- Protocol no.
- CAAA817A12201
- Conditions
- Prostate Cancer
- Interventions
- Drug
Treatments studied
- Investigators choice of SoC
- AAA817
- AAA817
- AAA817
Locations · 93
- Basel, SwitzerlandNovartis Investigative SiteRecruiting at this site
- Bellinzona, SwitzerlandNovartis Investigative SiteRecruiting at this site
- Bern, SwitzerlandNovartis Investigative SiteRecruiting at this site
- Scottsdale, United StatesHonor Health Research InstituteRecruiting at this site
- Los Angeles, United StatesVA Greater LA Healthcare SystemRecruiting at this site
- Palo Alto, United StatesVA Palo Alto Health Care SystemRecruiting at this site
- Palo Alto, United StatesStanford University Medical CenterRecruiting at this site
- Santa Barbara, United StatesSansum ClinicRecruiting at this site
- Santa Monica, United StatesSaint Johns Cancer InstituteRecruiting at this site
- Denver, United StatesRocky Mountain Cancer CentersRecruiting at this site
- Hartford, United StatesHartford HospitalRecruiting at this site
- Miami, United StatesBaptist Health SouthRecruiting at this site
- Orlando, United StatesAdventHealthRecruiting at this site
- Athens, United StatesUniversity Cancer and Blood Center LLCRecruiting at this site
- Atlanta, United StatesEmory UniversityRecruiting at this site
- Chicago, United StatesUniversity of ChicagoRecruiting at this site
- Indianapolis, United StatesIndiana UniversityRecruiting at this site
- Kansas City, United StatesUniversity of Kansas HospitalRecruiting at this site
- Metairie, United StatesEast Jefferson HospitalRecruiting at this site
- Boston, United StatesDana Farber Cancer InstituteRecruiting at this site
- Boston, United StatesBeth Israel Deaconess Medical CenterRecruiting at this site
- St Louis, United StatesWA Uni School Of MedRecruiting at this site
- Omaha, United StatesNebraska Cancer SpecialistsRecruiting at this site
- Voorhees Township, United StatesNew Jersey Urology LLCRecruiting at this site
- New York, United StatesMount Sinai Hosp Med SchoolRecruiting at this site
- Syracuse, United StatesAssociated Med Professionals of NYRecruiting at this site
- The Bronx, United StatesMontefiore Medical CenterRecruiting at this site
- Gahanna, United StatesCentral Ohio Urology GroupRecruiting at this site
- Springfield, United StatesOregon Urology InstituteRecruiting at this site
- Philadelphia, United StatesFox Chase Cancer CenterRecruiting at this site
In total, worldwide, all 93 sites listed in the registry are recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: September 22, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 63 more locations
Other identifiers
- 2024-512342-42-00 · other identifier
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.