34 recruiting, 14 active not recruiting, 9 completed, 6 not yet recruiting. 43 Phase 2, 22 Phase 1, 8 Phase 3, 2 Phase 4, 1 Early Phase 1.
Follow Pluvicto: new trials by email Literature Review of Pluvicto trials Research Report on Pluvicto
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Testing the Use of High Dose Testosterone Followed by Darolutamide Compared to the Usual Care for Patients With Metastatic Prostate Cancer Abiraterone Acetate, Biospecimen Collection, Bone Scan - Metastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8 | Phase 2 / Phase 3 | Not yet recruiting | ECOG-ACRIN Cancer Research Group | 432 | 2027-01-06 | 2026-10-01 |
| Escalating Cycle 1 Dose of Lu-177-PSMA-617 for the Treatment of Metastatic Castration Resistant Prostate Cancer Biospecimen Collection, Computed Tomography, Gallium Ga 68 Gozetotide - Metastatic Castration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8 | Phase 1 | Not yet recruiting | University of Michigan Rogel Cancer Center | 20 | 2026-12-01 | 2026-10-15 |
| Measuring Circulating Tumor Deoxyribonucleic Acid Tumor Fraction to Guide Early 177Lu-PSMA-617 Treatment Discontinuation in Patients With Metastatic Castration-Resistant Prostate Cancer, DYNAMO Trial Lutetium Lu 177 Vipivotide Tetraxetan, Cell-free Circulating Tumor DNA Assay, Computed Tomography - Metastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8 | Phase 2 | Recruiting | University of Washington | 64 | 2026-11-15 | 2026-10-19 |
| Pluvicto for the Treatment of African American Men With Metastatic Castration-Resistant Prostate Cancer Biopsy Procedure, Biospecimen Collection, Bone Scan - Metastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8 | Phase 2 | Not yet recruiting | Emory University | 88 | 2026-11-02 | 2026-10-06 |
| Impact of Body Composition on Dosimetry of 177Lu-PSMA Radioligand Therapy 177Lu-PSMA-617 + SPECT/CT dosimetry - Carcinoma, Castration Resistant Prostatic Neoplasms | Not applicable | Not yet recruiting | Centre Henri Becquerel | 100 | 2026-09-01 | 2026-05-14 |
| PSMA-High: EBRT/ PSMA617/ ADT vs. EBRT/ ADT EBRT + 6 mo ADT + 177Lu-PSMA-617, EBRT + 24 mo ADT - High-Risk Localized Prostate Cancer | Phase 2 | Recruiting | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 60 | 2026-08-17 | 2026-09-22 |
| Predictive Factors for Response to Lutetium-177 PSMA Radioligand Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer [177Lu]Lu-PSMA-617 (Pluvicto, Novartis), 68Ga-PSMA-11 PET/CT, Post-therapy 177Lu-PSMA SPECT/CT dosimetry - Prostate Cancer, Prostatic Neoplasms | Recruiting | Lithuanian University of Health Sciences | 70 | 2026-08-04 | 2026-10-14 | |
| Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial Abiraterone Acetate, Biospecimen Collection, Leuprolide Acetate - Recurrent Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8 | Phase 2 | Recruiting | Mayo Clinic | 202 | 2026-08-04 | 2026-09-18 |
| 177Lu-PSMA-617 Combined With Darolutamide in Neoadjuvant Treatment of High-risk Localized Prostate Cancer: a Prospective, Single-arm, Multi-center Clinical Trial Darolutamide combined with 177Lu-PSMA-617 - Prostate Cancer, Prostate Cancer Patients | Phase 4 | Not yet recruiting | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | 20 | 2026-07-01 | 2026-07-01 |
| 68Ga-PSMA-11 PET-directed Radioligand Therapy in Metastatic Hepatocellular Carcinoma (HCC) Lu-PSMA-617 - Liver Cancer, Hepatocellular Carcinoma | Phase 2 | Recruiting | Melissa Lumish | 10 | 2026-06-01 | 2026-05-08 |
| Lu-177 PSMA Treatment in Cell Renal Carcinoma Lu-177 PSMA-617 - Metastatic Renal Cancer | Phase 3 | Not yet recruiting | Ankara University | 20 | 2026-05-01 | 2026-02-27 |
| Radiopharmaceutical Treatment of Advanced Kidney Cancer 177Lu-PSMA-617 - Metastatic Clear Cell Renal Cell Carcinoma | Phase 2 | Recruiting | European Organisation for Research and Treatment of Cancer - EORTC | 48 | 2026-04-07 | 2026-06-04 |
| Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial Lutetium Lu 177 Vipivotide Tetraxetan, Biospecimen Collection, Patient Monitoring - Metastatic Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma | Phase 3 | Recruiting | Alliance for Clinical Trials in Oncology | 1524 | 2026-03-31 | 2026-10-02 |
| 177Lu-PSMA-617 With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer 177Lu-PSMA-617, Ablation, Trans-arterial chemoembolization (TACE) - Metastatic Prostate Cancer, Prostate Cancer | Phase 1 | Recruiting | University of California, San Francisco | 30 | 2026-03-16 | 2026-06-01 |
| 177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate Cancer Biospecimen Collection, Bone Scan, Computed Tomography - Metastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8 | Phase 1 | Recruiting | City of Hope Medical Center | 30 | 2026-03-06 | 2026-04-20 |
| Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide With Metastasis-Directed Stereotactic Body Radiotherapy for the Treatment of Recurrent, Oligometastatic Prostate Adenocarcinoma Actinium Ac 225 Vipivotide Tetraxetan, Biospecimen Collection, Gallium Ga 68 Gozetotide - Oligometastatic Prostate Adenocarcinoma, Recurrent Prostate Adenocarcinoma | Phase 2 | Recruiting | Jonsson Comprehensive Cancer Center | 107 | 2025-12-12 | 2026-09-17 |
| A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC AMO959, AAA617, Enzalutamide - PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC) With Prior Exposure to One Prior ARPI Who Are Candidates for Taxane-based Chemotherapy | Phase 1 / Phase 2 | Recruiting | Novartis Pharmaceuticals | 123 | 2025-12-05 | 2026-10-15 |
| A Study of 177Lu-PSMA-617 in People With Gliomas Temozolomide, 177Lu-PSMA-617, 68Ga-PSMA-PET scan/ MRI - Glioma, Diffuse Astrocytoma, IDH-Wildtype (Grade 2-4) | Phase 1 | Recruiting | Memorial Sloan Kettering Cancer Center | 20 | 2025-10-27 | 2026-06-04 |
| An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC AAA617, ARPI: Abiraterone, ARPI: Enzalutamide - Metastatic Castration Resistant Prostate Cancer (mCRPC) | Phase 2 | Active not recruiting | Novartis Pharmaceuticals | 7 | 2025-09-11 | 2026-10-21 |
| Personalized vs. Fixed-Activity 177Lu-PSMA-617 Radiopharmaceutical Therapy (PRODIGY-2) 177Lu-PSMA-617 - Metastatic Castrate Resistant Prostate Cancer (mCRPC) | Phase 1 | Recruiting | Jean-Mathieu Beauregard | 60 | 2025-08-15 | 2025-09-09 |
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Prostatic Neoplasms (49) · Kidney Neoplasms (3) · Prostatic Neoplasms, Castration-Resistant (3) · Carcinoma, Renal Cell (2) · Neoplasm Metastasis (2) · Prostatic Diseases (2) · Anemia (1) · Astrocytoma (1) · Carcinoma (1) · Carcinoma, Hepatocellular (1) · Clear-cell metastatic renal cell carcinoma (1) · Cytopenia (1) · Disease (1) · Genital Diseases, Male (1) · Genital Neoplasms, Male (1)
Novartis Pharmaceuticals (10) · Jonsson Comprehensive Cancer Center (3) · Peter MacCallum Cancer Centre, Australia (3) · University of California, San Francisco (3) · Weill Medical College of Cornell University (3) · Alliance for Clinical Trials in Oncology (2) · Australian and New Zealand Urogenital and Prostate Cancer Trials Group (2) · Dana-Farber Cancer Institute (2) · Endocyte (2) · Mayo Clinic (2) · Memorial Sloan Kettering Cancer Center (2) · Radboud University Medical Center (2) · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (2) · University of Washington (2) · Advanced Accelerator Applications (1)
United States (46) · France (13) · Netherlands (9) · Canada (8) · Germany (8) · Spain (8) · Australia (7) · Czechia (5) · United Kingdom (5) · Austria (4) · Belgium (4) · Italy (4) · Poland (4) · South Korea (4) · Sweden (4)
Rahul Aggarwal, MD (3) · Brandon Imber, MD (2) · James Nagarajah, Prof. (2) · Michael Schweizer (2) · Praful Ravi, MB BCHir, MRCP (2) · Scott Tagawa, MD (2) · Alex Chehrazi-Raffle, MD (1) · Amar Kishan (1) · Ana Kiess (1) · Ana Kiess, MD, PhD (1) · Angela Castellanos Rodriguez, MD, MSc (1) · Angela Y Jia, MD, PhD (1) · Arun Azad, MBBS PhD FRACP (1)
PMID 31595044, PMID 33465252, PMID 32928177, PMID 33189510, PMID 33581798, PMID 33883176, PMID 34161051, PMID 34246328, PMID 34373282, PMID 34736509, PMID 36261050, PMID 36350899, PMID 36692682, PMID 36959540, PMID 37230533, PMID 37269841, PMID 37891072, PMID 37922930, PMID 38043558, PMID 38050121, PMID 38185538, PMID 38534939, PMID 39031642, PMID 39162634, PMID 39242323, PMID 39293461, PMID 39293462, PMID 39430616, PMID 39978808, PMID 40425844, PMID 40441170, PMID 40638023, PMID 40680993, PMID 40876952, PMID 40935614, PMID 41073165, PMID 41545068, PMID 41679923, PMID 41785440, PMID 41926960, PMID 41979224, PMID 42561994
2023 (4), 2018 (1), 2025 (1), I01CX002775 (1), P01CA272222 (1), P30CA033572 (1), P30CA138292 (1), R01CA229354 (1), R01CA289631 (1), R37CA286450 (1), U10CA180820 (1)