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Compound · clinical trials

AAA617

Also listed in trial records as 177Lu-PSMA-617
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 10 trials in our USA, UK and China registers that name AAA617 as an intervention. Synced 24 Sep 2026
10Trials tracked
3Recruiting now
2Lead sponsors
3Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards

AAA617 is named as a drug or biological intervention in 10 clinical trials in our USA, UK and China trial registers, 3 of which are recruiting. Lead sponsors include Novartis Pharmaceuticals (9) and The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (1). Registered phases: Phase 2, Phase 3, Phase 4 and Phase 1. Conditions studied include Prostate Cancer; Prostatic Neoplasms; Metastatic Castration-Resistant Prostate Cancer.

01

Clinical trials of AAA617

10 trials
NCT IDStudyPhaseStatusLead sponsorRegister
NCT05803941 Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer (ClinicalTrials.gov ↗)
Prostate Cancer
Phase 4 Recruiting Novartis Pharmaceuticals UK, USA
NCT05939414 An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC. (ClinicalTrials.gov ↗)
Oligometastatic Prostate Cancer (OMPC)
Phase 3 Recruiting Novartis Pharmaceuticals UK, USA, China
NCT06531499 A Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naรฏve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study (ClinicalTrials.gov ↗)
Metastatic Castration-Resistant Prostate Cancer
Phase 1 Recruiting Novartis Pharmaceuticals UK, USA
NCT07677566 177Lu-PSMA-617 Combined With Darolutamide in Neoadjuvant Treatment of High-risk Localized Prostate Cancer: a Prospective, Single-arm, Multi-center Clinical Trial (ClinicalTrials.gov ↗)
Prostate Cancer, Prostate Cancer Patients
Phase 4 Not yet open The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School China
NCT04689828 177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer (ClinicalTrials.gov ↗)
Prostatic Neoplasms
Phase 3 Active, closed Novartis Pharmaceuticals UK, USA
NCT04720157 An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) (ClinicalTrials.gov ↗)
Prostatic Neoplasms
Phase 3 Active, closed Novartis Pharmaceuticals UK, USA, China
NCT05849298 A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC (ClinicalTrials.gov ↗)
Prostatic Neoplasm
Phase 2 Active, closed Novartis Pharmaceuticals USA
NCT06004661 Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function (ClinicalTrials.gov ↗)
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Phase 2 Active, closed Novartis Pharmaceuticals USA
NCT06894511 An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC (ClinicalTrials.gov ↗)
Metastatic Castration Resistant Prostate Cancer (mCRPC)
Phase 2 Active, closed Novartis Pharmaceuticals USA
NCT07047118 A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) (ClinicalTrials.gov ↗)
Prostatic Cancer, Castration-Resistant
Phase 2 Active, closed Novartis Pharmaceuticals USA, China

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied

9 conditions
Condition (as registered)Trials
Prostate Cancer2
Prostatic Neoplasms2
Metastatic Castration-Resistant Prostate Cancer1
Oligometastatic Prostate Cancer (OMPC)1
Metastatic Castration Resistant Prostate Cancer (mCRPC)1
Prostatic Neoplasm1
Metastatic Castration-Resistant Prostate Cancer (mCRPC)1
Prostatic Cancer, Castration-Resistant1
Prostate Cancer Patients1
03

Sponsors

lead sponsor per trial
Lead sponsorTrials
Novartis Pharmaceuticals9
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1
04

Trials by country register

A trial with sites in more than one country appears in each of those registers.

How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how AAA617 works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists AAA617 (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 24 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.