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Compound · clinical trials

Lu-PSMA clinical trials

Also listed in trial records as AAA617, [177Lu]Lu-PSMA-617, 177Lu-PSMA-617, [177Lu]Lu-PSMA I&T, 177Lu-PSMA, Psma-Rlt, C49H71N9O16
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 26 trials in our USA, France, Germany, Spain, Canada, Austria, Australia, UK, Netherlands, Czechia, Italy, China, Israel, Switzerland, Belgium, Singapore, Sweden, Poland, South Korea, Taiwan, Mexico, Japan, Brazil and Denmark registers that name Lu-PSMA as an intervention. Synced 29 Sep 2026
26Current trials
10Recruiting now
11Lead sponsors
24Country 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
At a glance

Lu-PSMA is named as an intervention in 26 current clinical trials in our USA, France, Germany, Spain, Canada, Austria, Australia, UK, Netherlands, Czechia, Italy, China, Israel, Switzerland, Belgium, Singapore, Sweden, Poland, South Korea, Taiwan, Mexico, Japan, Brazil and Denmark registers. 10 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Novartis Pharmaceuticals (11). The most-studied condition is Prostate Cancer.

Trials by status

  • Recruiting1038%
  • Not yet open14%
  • Active, closed1558%

Trials by phase

  • Phase 21558%
  • Phase 1415%
  • Phase 3312%
  • Phase 428%
  • Phase 1/228%
01

Clinical trials of Lu-PSMA

26 trials
StudyPhaseStatusLead sponsorRegisters
Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer
NCT05803941 · ClinicalTrials.gov ↗ · Prostate Cancer
Phase 4 Recruiting Novartis Pharmaceuticals UK, USA, Germany, France, Spain, Netherlands, Belgium, Sweden, Austria, Czechia, Canada
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.
NCT05939414 · ClinicalTrials.gov ↗ · Oligometastatic Prostate Cancer (OMPC)
Phase 3 Recruiting Novartis Pharmaceuticals UK, USA, China, Germany, France, Spain, Italy, Netherlands, Belgium, Switzerland, Austria, Czechia, Canada, Brazil, Mexico, Japan, Taiwan, Singapore, Australia, Israel
Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy
NCT05560659 · ClinicalTrials.gov ↗ · Oligometastatic Prostate Cancer
Phase 2 Recruiting Peter MacCallum Cancer Centre, Australia Australia, Israel
Lu-PSMA and Stereotactic Radiotherapy Versus Radiotherapy Alone for Prostate Cancer (LUST)
NCT05893381 · ClinicalTrials.gov ↗ · Prostate Cancer
Phase 2 Recruiting Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS Italy
PSMA-RLT in Biochemically Recurrent PCa
NCT06220188 · ClinicalTrials.gov ↗ · Prostate Cancer Recurrent
Phase 2 Recruiting Medical University of Vienna Austria
Neoadjuvant PSMA-RLT in Oligometastatic PCa
NCT06259123 · Prostate Cancer
Phase 2 Recruiting Medical University of Vienna Austria
Radiopharmaceutical Treatment of Advanced Kidney Cancer
NCT06783348 · ClinicalTrials.gov ↗ · Metastatic Clear Cell Renal Cell Carcinoma
Phase 2 Recruiting European Organisation for Research and Treatment of Cancer - EORTC France
Study of Re-treatment With [177Lu]Lu-PSMA in Men With Metastatic Castration Resistance Prostate Cancer
NCT06866938 · ClinicalTrials.gov ↗ · Metastatic Castration-resistant Prostate Cancer
Phase 2 Recruiting Hospices Civils de Lyon France
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
NCT06531499 · Metastatic Castration-Resistant Prostate Cancer
Phase 1 Recruiting Novartis Pharmaceuticals UK, USA, Germany, Spain, Netherlands, Switzerland
Personalized vs. Fixed-Activity 177Lu-PSMA-617 Radiopharmaceutical Therapy (PRODIGY-2)
NCT06943495 · ClinicalTrials.gov ↗ · Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Phase 1 Recruiting Jean-Mathieu Beauregard Canada
177Lu-PSMA-617 Combined With Darolutamide in Neoadjuvant Treatment of High-risk Localized Prostate Cancer: a Prospective, Single-arm, Multi-center Clinical Trial
NCT07677566 · ClinicalTrials.gov ↗ · Prostate Cancer, Prostate Cancer Patients
Phase 4 Not yet open The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School China
177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer
NCT04689828 · ClinicalTrials.gov ↗ · Prostatic Neoplasms
Phase 3 Active, closed Novartis Pharmaceuticals UK, USA, Germany, France, Spain, Netherlands, Belgium, Sweden, Poland, Switzerland, Austria, Czechia, Canada, Israel
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)
NCT04720157 · ClinicalTrials.gov ↗ · Prostatic Neoplasms
Phase 3 Active, closed Novartis Pharmaceuticals UK, USA, China, Germany, France, Spain, Netherlands, Belgium, Sweden, Denmark, Poland, Switzerland, Austria, Czechia, Canada, Mexico, Japan, South Korea, Taiwan, Singapore
In Men With Metastatic Prostate Cancer, What is the Safety and Benefit of Lutetium-177 PSMA Radionuclide Treatment in Addition to Chemotherapy
NCT04343885 · ClinicalTrials.gov ↗ · Metastatic Hormone Naive Prostate Cancer
Phase 2 Active, closed Peter MacCallum Cancer Centre, Australia Australia
Enzalutamide With Lu PSMA-617 Versus Enzalutamide Alone in Men With Metastatic Castration-resistant Prostate Cancer
NCT04419402 · ClinicalTrials.gov ↗ · Metastatic Castration-Resistant Prostate Cancer
Phase 2 Active, closed Australian and New Zealand Urogenital and Prostate Cancer Trials Group Australia
177 LuPSMA-617 vs Docetaxel in Metastatic Castration Resistant and PSMA-Positive Prostate Cancer
NCT04663997 · ClinicalTrials.gov ↗ · Prostate Cancer
Phase 2 Active, closed Canadian Cancer Trials Group Canada
A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxane Treatment Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer
NCT05658003 · ClinicalTrials.gov ↗ · Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Phase 2 Active, closed Novartis Pharmaceuticals China
A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC
NCT05849298 · ClinicalTrials.gov ↗ · Prostatic Neoplasm
Phase 2 Active, closed Novartis Pharmaceuticals USA, Germany, France, Spain, Italy, Poland, Czechia, Canada, Brazil, South Korea, Singapore
Radiometabolic Therapy With 177Lu PSMA in PSMA PET/CT Positive Advanced/Metastatic Tumours:
NCT05867615 · ClinicalTrials.gov ↗ · Cancer
Phase 2 Active, closed Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS Italy
Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function
NCT06004661 · ClinicalTrials.gov ↗ · Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Phase 2 Active, closed Novartis Pharmaceuticals USA, Germany, France, Spain, Italy
An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC
NCT06894511 · ClinicalTrials.gov ↗ · Metastatic Castration Resistant Prostate Cancer (mCRPC)
Phase 2 Active, closed Novartis Pharmaceuticals USA
A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
NCT07047118 · ClinicalTrials.gov ↗ · Prostatic Cancer, Castration-Resistant
Phase 2 Active, closed Novartis Pharmaceuticals USA, China, Germany, France, Spain, Italy, Netherlands, Austria, Czechia, Canada, South Korea, Taiwan, Singapore, Australia, Israel
Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy
NCT04430192 · ClinicalTrials.gov ↗ · Prostatic Neoplasms
Phase 1/2 Active, closed Peter MacCallum Cancer Centre, Australia Australia
Cabazitaxel in Combination With 177Lu-PSMA-617 in Metastatic Castration-resistant Prostate Cancer
NCT05340374 · ClinicalTrials.gov ↗ · Metastatic Castration-resistant Prostate Cancer, mCRPC
Phase 1/2 Active, closed Peter MacCallum Cancer Centre, Australia Australia
LuCarbo - a Study of 177Lu-PSMA-617 Plus Carboplatin in Metastatic Castrate-resistant Prostate Cancer
NCT06303713 · ClinicalTrials.gov ↗ · Prostate Cancer, Metastatic Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
Phase 1 Active, closed Dana-Farber Cancer Institute Israel
NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.
NCT06379217 · ClinicalTrials.gov ↗ · Metastatic Neuroendocrine Prostate Cancer
Phase 1 Active, closed Novartis Pharmaceuticals UK, USA, Germany, France, Spain

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 with Lu-PSMA

19 conditions
Prostate Cancer6Prostatic Neoplasms3Metastatic Castration-resistant Prostate Cancer3Metastatic Castration-Resistant Prostate Cancer2Metastatic Castration-Resistant Prostate Cancer (mCRPC)2Oligometastatic Prostate Cancer (OMPC)1Prostatic Neoplasm1Prostatic Cancer, Castration-Resistant1Metastatic Castration Resistant Prostate Cancer (mCRPC)1Metastatic Neuroendocrine Prostate Cancer1Prostate Cancer Patients1Metastatic Clear Cell Renal Cell Carcinoma1
All 19 conditions
Condition (as registered)Trials
Prostate Cancer6
Prostatic Neoplasms3
Metastatic Castration-resistant Prostate Cancer3
Metastatic Castration-Resistant Prostate Cancer2
Metastatic Castration-Resistant Prostate Cancer (mCRPC)2
Oligometastatic Prostate Cancer (OMPC)1
Prostatic Neoplasm1
Prostatic Cancer, Castration-Resistant1
Metastatic Castration Resistant Prostate Cancer (mCRPC)1
Metastatic Neuroendocrine Prostate Cancer1
Prostate Cancer Patients1
Metastatic Clear Cell Renal Cell Carcinoma1
Metastatic Castrate Resistant Prostate Cancer (mCRPC)1
Metastatic Hormone Naive Prostate Cancer1
mCRPC1
Metastatic Prostate Cancer1
Cancer1
Prostate Cancer Recurrent1
Oligometastatic Prostate Cancer1
03

Sponsors

lead sponsor per trial
Lead sponsorTrials
Novartis Pharmaceuticals11
Peter MacCallum Cancer Centre, Australia4
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS2
Medical University of Vienna2
Hospices Civils de Lyon1
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1
European Organisation for Research and Treatment of Cancer - EORTC1
Jean-Mathieu Beauregard1
Canadian Cancer Trials Group1
Dana-Farber Cancer Institute1
Australian and New Zealand Urogenital and Prostate Cancer Trials Group1
04

By country register

RegisterTrialsRecruiting
Clinical trials in USA103
Clinical trials in France104
Clinical trials in Germany93
Clinical trials in Spain93
Clinical trials in Canada83
Clinical trials in Austria74
Clinical trials in Australia72
Clinical trials in UK63
Clinical trials in Netherlands63
Clinical trials in Czechia62
Clinical trials in Italy62
Clinical trials in China51
Clinical trials in Israel52
Clinical trials in Switzerland42
Clinical trials in Belgium42
Clinical trials in Singapore41
Clinical trials in Sweden31
Clinical trials in Poland30
Clinical trials in South Korea30
Clinical trials in Taiwan31
Clinical trials in Mexico21
Clinical trials in Japan21
Clinical trials in Brazil21
Clinical trials in Denmark10

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

05

Related compounds

06

Questions about Lu-PSMA trials

How many clinical trials are testing Lu-PSMA?

26 current trials in our USA, France, Germany, Spain, Canada, Austria, Australia, UK, Netherlands, Czechia, Italy, China, Israel, Switzerland, Belgium, Singapore, Sweden, Poland, South Korea, Taiwan, Mexico, Japan, Brazil and Denmark registers name Lu-PSMA (also registered as AAA617) as a drug or biological intervention, as of the registry sync on 29 September 2026. Completed and withdrawn studies are not counted.

Are Lu-PSMA trials recruiting patients?

Yes. 10 of the 26 trials are recruiting: 3 with sites in USA, 4 with sites in France, 3 with sites in Germany, 3 with sites in Spain, 3 with sites in Canada, 4 with sites in Austria, 2 with sites in Australia, 3 with sites in UK, 3 with sites in Netherlands, 2 with sites in Czechia, 2 with sites in Italy, 1 with sites in China, 2 with sites in Israel, 2 with sites in Switzerland, 2 with sites in Belgium, 1 with sites in Singapore, 1 with sites in Sweden, 1 with sites in Taiwan, 1 with sites in Mexico, 1 with sites in Japan and 1 with sites in Brazil. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Lu-PSMA clinical trials?

Novartis Pharmaceuticals (11), Peter MacCallum Cancer Centre, Australia (4), Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS (2) and Medical University of Vienna (2), among 11 lead sponsors in total. The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Lu-PSMA works or whether it is effective, and it is not medical advice.

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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 Lu-PSMA 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 Lu-PSMA (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 29 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.