22 completed, 12 active not recruiting, 10 recruiting, 4 terminated. 29 Phase 2, 12 Phase 3, 9 Phase 1, 8 Early Phase 1, 4 Not applicable.
Follow 68Ga-PSMA-11: new trials by email Literature Review of 68Ga-PSMA-11 trials Research Report on 68Ga-PSMA-11
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 |
|---|---|---|---|---|---|---|
| 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 |
| Response With Interim PSMA PET in Metastatic Castration-sensitive Prostate Cancer for Optimization of Adaptive Metastasis-directed Radiotherapy Delivery Drug: 68-Ga PSMA11, Adaptive stereotactic ablative radiotherapy (SABR), 68Ga-PSMA-11 - Prostate Cancer, Castration Sensitive Prostate Cancer | Early Phase 1 | Not yet recruiting | University of Texas Southwestern Medical Center | 30 | 2026-10-01 | 2026-08-24 |
| Imaging Characteristics of Different ⁶⁸Ga-PSMA Probes in Prostate Cancer 68Ga-GS24-B2-268-T, 68Ga-GS24-B2-250-T, 68Ga-GS24-B2-237-T - Prostate Cancer | Not applicable | Not yet recruiting | Shanghai Zhongshan Hospital | 9 | 2026-01-19 | 2026-01-26 |
| An Investigational Scan (Ga-68 PSMA-11 PET/CT) for Detection of Disease Recurrence or Progression in Patients With Glioma Computed Tomography, Electronic Health Record Review, Ga 68 PSMA-11 - WHO Grade 3 Glioma, WHO Grade 4 Glioma | Phase 2 | Recruiting | Mayo Clinic | 25 | 2026-01-12 | 2026-06-22 |
| 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 |
| PSMA PET Combined With MRI for the Detection of PCa 68Ga-PSMA-11 - PCA, Prostate Cancer | Phase 3 | Active not recruiting | Telix Pharmaceuticals (Innovations) Pty Limited | 338 | 2025-08-18 | 2026-10-20 |
| Phase 2 Clinical Trial of 225Ac-LNC1011 in the Treatment of Metastatic Castration-Resistant Prostate Cancer 225Ac-LNC1011, 68Ga-PSMA-11 - Prostate Cancer | Phase 2 | Active not recruiting | First Affiliated Hospital of Fujian Medical University | 24 | 2025-04-22 | 2026-10-23 |
| 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 |
| An Investigational Scan (Ga-68 PSMA-11 PET/CT) for the Detection of Therapy Response in Patients With Metastatic Adenoid Cystic Carcinoma Computed Tomography, Electronic Health Record Review, Ga-68 PSMA-11 - Metastatic Adenoid Cystic Carcinoma | Phase 2 | Completed | Mayo Clinic | 6 | 2024-08-12 | 2025-09-12 |
| 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 |
| 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 |
| Hormone Therapy (Apalutamide) and Image-guided Stereotactic Body Radiation Therapy for the Treatment of Patients With Prostate Cancer, HEATWAVE Trial Apalutamide, Biospecimen Collection, Computed Tomography - Prostate Adenocarcinoma, Stage II Prostate Cancer AJCC v8 | Phase 2 | Recruiting | Jonsson Comprehensive Cancer Center | 95 | 2024-03-28 | 2026-07-17 |
| 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 |
| Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT 225Ac-PSMA-R2, 68Ga-PSMA-R2, 68Ga-PSMA-11 - Prostate Cancer | Phase 1 | Active not recruiting | Novartis Pharmaceuticals | 33 | 2023-11-07 | 2026-09-11 |
| 68Ga-PSMA-11 Efficacy in Detecting BCR Prostate Cancer in Chinese Patients 68Ga-PSMA-11, PET/CT or PET/MRI - Biochemical Recurrence of Malignant Neoplasm of Prostate, Prostate Cancer | Phase 3 | Unknown | Telix Pharmaceuticals (Innovations) Pty Limited | 110 | 2023-07-19 | 2024-07-03 |
| A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Dosimetry of [177Lu]Lu-PSMA-617 in Chinese Adult Male Patients With Progressive PSMA-Positive mCRPC [177Lu]Lu-PSMA-617, Best supportive/best standard of care (BS/BSOC), 68Ga-PSMA-11 - Metastatic Castration-Resistant Prostate Cancer (mCRPC) | Phase 2 | Completed | Novartis Pharmaceuticals | 62 | 2023-05-16 | 2026-09-15 |
| Gallium-68 PSMA-11 PET in Participants With Prostate Cancer Computed Tomography, Gallium Ga 68-labeled PSMA-11, Magnetic Resonance Imaging - Metastatic Prostate Carcinoma, Recurrent Prostate Carcinoma | Phase 2 | Withdrawn | M.D. Anderson Cancer Center | 2022-09-26 | 2024-03-07 | |
| Head-to-head Comparison of 68Ga-PSMA-11 and 18F-PSMA-1007 18F-PSMA-1007, 68Ga-PSMA-11 - Prostate Cancer | Not applicable | Completed | Insel Gruppe AG, University Hospital Bern | 100 | 2022-07-07 | 2024-12-10 |
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Prostatic Neoplasms (45) · Carcinoma, Hepatocellular (4) · Ovarian Neoplasms (2) · Adenocarcinoma (1) · Breast Neoplasms (1) · Carcinoma, Adenoid Cystic (1) · Carcinoma, Lobular (1) · Carcinoma, Renal Cell (1) · Colonic Neoplasms (1) · Esophageal Neoplasms (1) · Lung Neoplasms (1) · Neoplasm Metastasis (1) · Neoplasms (1) · Pancreatic Neoplasms (1) · Prostatic Diseases (1)
Jonsson Comprehensive Cancer Center (14) · Mayo Clinic (8) · Novartis Pharmaceuticals (7) · Andrei Iagaru (3) · First Affiliated Hospital of Fujian Medical University (3) · Peking Union Medical College Hospital (2) · Telix Pharmaceuticals (Innovations) Pty Limited (2) · University of California, San Francisco (2) · Weill Medical College of Cornell University (2) · British Columbia Cancer Agency (1) · Cancer Targeted Technology (1) · Central Hospital, Nancy, France (1) · City of Hope Medical Center (1) · Dana Mathews (1) · Emory University (1)
United States (46) · China (8) · Canada (6) · France (6) · Germany (4) · Spain (4) · Czechia (3) · Italy (3) · Poland (3) · Switzerland (3) · Australia (2) · Austria (2) · Belgium (2) · Japan (2) · Netherlands (2)
Jeremie Calais (5) · Jeremie Calais, MD (3) · Ajit H. Goenka, M.D. (2) · Amar Kishan (2) · Brian J. Burkett, MD, MPH (2) · Andrea Farolfi, MD (1) · Andrei H Iagaru, MD (1) · Andrei Iagaru (1) · Andrei Iagaru, MD (1) · Axel Rominger, MD (1) · Beatrice Langton-Webster, PhD (1) · David M Schuster, MD (1) · Delphine L. Chen, M.D. (1)
PMID 41698328, PMID 31375469, PMID 33602654, PMID 36512649, PMID 29242398, PMID 29242404, PMID 30616601, PMID 30920593, PMID 32808077, PMID 32958451, PMID 33386288, PMID 33674398, PMID 34326126, PMID 34406051, PMID 34529005, PMID 34649942, PMID 34783177, PMID 35853017, PMID 36396456, PMID 37233785, PMID 37482512, PMID 37902861, PMID 38976035, PMID 39136560, PMID 39254446, PMID 39293462, PMID 39420060, PMID 40441170, PMID 40638023, PMID 40680993, PMID 40876952, PMID 41101974, PMID 41366119, PMID 41679923, PMID 41764712, PMID 42561994
2023 (3), P30CA033572 (1), P30CA138292 (1), R01CA289631 (1), R37CA286450 (1), R44CA239461 (1)