12 recruiting, 6 active not recruiting, 3 not yet recruiting, 1 completed. 16 Phase 2, 4 Phase 1, 4 Phase 3, 1 Phase 4.
Follow AAA617: new trials by email Literature Review of AAA617 trials Research Report on AAA617
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 |
| 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 |
| 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 |
| 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 |
| A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) JSB462, AAA617 - Prostatic Cancer, Castration-Resistant | Phase 2 | Active not recruiting | Novartis Pharmaceuticals | 138 | 2025-07-03 | 2026-10-09 |
| Low PSMA SUV Boost (LPS-Boost): Intensified 177Lu-PSMA-617 Treatment for Patients With Metastatic Castrate-Resistant Prostate Cancer With Low PSMA Expressing Disease Biospecimen Collection, Bone Scan, Computed Tomography - Metastatic Castration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8 | Phase 2 | Recruiting | University of Washington | 51 | 2025-04-29 | 2026-07-07 |
| A Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study AAA617, Gonadotropin-releasing hormone (GnRH) analogues, Gonadotropin-releasing hormone (GnRH) antagonists - Metastatic Castration-Resistant Prostate Cancer | Phase 1 | Active not recruiting | Novartis Pharmaceuticals | 110 | 2024-11-11 | 2026-10-20 |
| Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer Biopsy Procedure, Biospecimen Collection, Bone Scan - Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma | Phase 2 | Recruiting | Fred Hutchinson Cancer Center | 15 | 2024-09-18 | 2026-08-06 |
| Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial Biospecimen Collection, Computed Tomography, Gallium Ga 68 Gozetotide - Castration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8 | Phase 2 | Recruiting | Jonsson Comprehensive Cancer Center | 40 | 2024-08-01 | 2026-03-13 |
| Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT) Computed Tomography, Gallium Ga 68 Gozetotide, Lutetium Lu 177 Vipivotide Tetraxetan - Prostate Carcinoma, Stage IVB Prostate Cancer American Joint Committee on Cancer (AJCC) v8 | Phase 2 | Recruiting | Jonsson Comprehensive Cancer Center | 90 | 2024-08-01 | 2026-03-10 |
| A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer Stereotactic Ablative Body Radiotherapy (SABR), 177Lu-PSMA-617, Androgen Deprivation Therapy (ADT) - Prostate Cancer Metastatic | Phase 3 | Recruiting | University College, London | 3360 | 2024-06-11 | 2025-09-26 |
| Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer Biospecimen Collection, Bone Scan, Clinical Observation - Castration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8 | Phase 2 | Suspended | Mayo Clinic | 236 | 2024-05-03 | 2026-08-20 |
| Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function AAA617, 68Ga-PSMA-11 - Metastatic Castration-Resistant Prostate Cancer (mCRPC) | Phase 2 | Active not recruiting | Novartis Pharmaceuticals | 23 | 2024-04-04 | 2026-07-10 |
| An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC. AAA617, piflufolastat (18F), gallium (68Ga) gozetotide (25μg) - Oligometastatic Prostate Cancer (OMPC) | Phase 3 | Recruiting | Novartis Pharmaceuticals | 450 | 2024-03-12 | 2026-10-21 |
| A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC AAA617, AAA517, Piflufolastat F 18 - Prostatic Neoplasm | Phase 2 | Active not recruiting | Novartis Pharmaceuticals | 49 | 2024-01-03 | 2026-10-21 |
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Prostatic Neoplasms (15) · Prostatic Neoplasms, Castration-Resistant (1) · Renal Insufficiency (1)
Novartis Pharmaceuticals (10) · Jonsson Comprehensive Cancer Center (3) · Mayo Clinic (2) · University of Washington (2) · City of Hope Medical Center (1) · ECOG-ACRIN Cancer Research Group (1) · Emory University (1) · Fred Hutchinson Cancer Center (1) · University College, London (1) · University of Michigan Rogel Cancer Center (1)
United States (20) · Germany (8) · Spain (8) · France (7) · Canada (5) · Czechia (5) · Italy (5) · Netherlands (5) · United Kingdom (5) · Austria (4) · China (4) · Singapore (4) · Australia (3) · Belgium (3) · Japan (3)
Michael Schweizer (2) · Alex Chehrazi-Raffle, MD (1) · Amar Kishan (1) · Angela Castellanos Rodriguez, MD, MSc (1) · Jacob E Berchuck, MD (1) · Jeremie Calais (1) · Jeremie Calais, MD (1) · Kirk A Frey, MD (1) · Louise Brown (1) · Matthew K. Tollefson, MD (1) · Matthew P. Thorpe, M.D., Ph.D. (1) · Michael Schweizer, MD (1) · Nick James (1)
PMID 40876952, PMID 41679923, PMID 41764712, PMID 42561994
2023 (3), 2025 (1), P30CA033572 (1), P30CA138292 (1), R01CA289631 (1), R37CA286450 (1), U10CA180820 (1)